All in Japan: Statins
Enterprise-wide Use License -
All
approved medicinal products
in Japan
STATINS
Table of Contents
1. Introduction
Key Findings
2. Type/generations of statins
Table 1. Type/generations of statins
3. Statin products approved in Japan
Table 2. Approval classification of the prescription
medicinal products
Table 3. Approval statistics of statin products in Japan
Graph 1. Approval share by type of statins
Graph 2. Approval share by approval class
Table 4. Alphabetical list of statin products approved in
Japan
Table 5. Individual statin products approved in Japan
Disclaimer and Publisher Information
Note: The documents from the Japan Monitor "All in Japan" series provide concise up-
to-date description of each product from a definite therapeutic category
approved in Japan. Further details could be found in the web site of JKS, in the
Key and Basic documents available in the JKS Document Store or by enquiring
directly to JKS at regulatory@jouhoukoukai.com.
1. Introduction
The prototype of the product line, known now as statins, was
discovered by Dr. Akira Endo in Sankyo's Tokyo laboratories in the early 1970s.
The identification of mevastatin (ML-236B, compactin) resulted from nearly a
century of biomedical research on the cholesterol biosynthesis, determining
HMG-CoA reductase function in the conversion to a key metabolic precursor,
mevalonate, provided the opportunity to therapeutically inhibit this enzyme.
The consequential intensive laboratory, preclinical and clinical
development led to the first world-wide approval of this prototype statin drug in
1986. Generically known as pravastatin sodium (and more commonly referred
to as just "pravastatin"), it was sold in US as Pravachol. In Japan pravastatin was
registered by Sankyo as Mevalotin which became the first Japanese domestic
"blockbuster" drug with sales over 1 billion US$ annually.
Further scientific endeavor and commercial competition has brought 8
chemical entities from the statin family to the international pharmaceutical
market (Table 1). In Japan, five of these statin entities (pravastatin, simvastatin,
fluvastatin, atorvastatin and pitavastatin) have gained approval, however in
2001 fluvastatin was withdrawn, while an application for Rosuvastatin was
submitted in 2003 and lovastatin is yet to enter development in Japan.
In terms of efficacy, statin entities are unofficially classified as I, II and III
generation, or alternatively as "standard" statins (I and II generation) and
"strong" or superstatins (III generation). Pitavastatin aside, the general trend has
been for the statin entity to be approved abroad before registered in Japan
albeit in case of simvastatin the difference between FDA and MHLW approval
timelines was on the scale of less than a year (Table 1).
In contrast to other therapeutic classes, the introduction and
development of statin medicinal products in Japan have been both
commercially highly successful and lacking the cultural controversies normally
associated with the launch of foreign based entities in Japan. However, the
incremental increase in Japan registered statins has been drastically affected by
two milestone events. Firstly, following a series of rhabdomyolysis-related deaths
worldwide, Bayer Yakuhin KK decided to voluntarily withdraw in 2001 Baycol
thus lowering the number of approved statins in Japan to just three. Secondly
the expiration of the patent rights for both pravastatin and simvastatin, resulted
in a flurry of generics approved en masse in July 2003. As detailed in Table 3
and Graph 1 and Graph 2, at present, the "standard" statins (or I generation)
group is completely dominated by generic versions namely 27 generic products
of pravastatin and 17 of simvastatin.
Regarding market prospects, some preliminary figures indicate that
market share of "standard" statins will further erode due to both advance of the
superstatins - including tentatively rosuvastatin, and ceding to generics
competitors. In May 2004, Sankyo KK released the Mevalotin revenues for the
fiscal 2002, 2003 and 2004 (estimation) as follows: 110.7, 98.3 and 82.3 billion
Yen and in efforts to bolster further sales attrition, have launched a marketing
strategy targeting the pleiotropic effects of the drug .
The overall outlook of the Japanese statin market is positive as New
Chemical Entity statins innovated from Japan pharma will continue to buoy the
dyslipidemia market, with a 55% stake of all Japan registered statins; pravastatin
continues to be the mainstay. Since expiry of the Mevalotin(r) patent in July
2003, competitiveness of the Japan statin market normally enticed by
blockbuster New Chemical Entities has become swamped by "standard" statin
generics, totaling a 86% share from both pravastatin and simvastatin Japan
registered statins alone. The Japanese superstatin market is still in its infancy
with only a mere representation of less than 6% of the total Japan registered
statins volume. The combined volume of standard and superstatins is projected
to exceed 2, 500 billion Yen in 2004 and near 4,000 billion Yen in 2008 .
Key Findings
* Apart from globally withdrawn cerivastatin, out of all 7
known New Chemical Entities of statins registered
world-wide, 5 are already approved in Japan and
Rosuvastatin is expecting approval.
* Post July 2003 expiry of the Mevalotin(r) patent saw the
MHLW approved 44 generics comprising of pravastatin
(27) and simvastatin (17) formulations, making up 86%
of the total Japan registered statins volume.
* Pravastatin still dominates the statin prescription
registry with 55% of the total Japan registered statins
volume, followed by simvastatin at 35%; the
superstatin class with pitavastatin and atorvastatin
accounts for barely under 6%.
* Currently only Mevalotin(r) and Mevatorte are the two
Japan registered statins prescribed as a granule
formulation in Japan.
* Time lag between international and Japanese
approvals has been 10 years, 3 years, 2 years, 2 years
and 0 years for fluvastatin, pravastatin, atorvastatin,
cerivastatin (withdrawn worldwide) and simvastatin
respectively.
2. Type/generations of statins
Table 1. Type/generations of statins
Statin
International status
Approval in Japan
Generic
Gene-
ration
Brand
First
approval
Maker /
Marketing
Approval
Brand
Maker /
Marketing
pravastatin
I
Pravachol
1986
BMS
1989
Mevalotin
(+ 27 generics)
Sankyo KK
lovastatin
I
Mevacor
1987
Merck
Not entered
simvastatin
I
Zocor
1991
Merck
1991
Lipovas
(+ 17 generics)
Banyu/Merck
fluvastatin
II
Lescol
1993
Novartis
2003
Lochol
Novartis Pharma
KK
cerivastatin
III
Baycol
1997
Bayer
1999
Baycol
Bayer Yakuhin
KK
atorvastatin
III
Lipitor
1998
Pfizer
2000
Lipitor
Pfizer KK
rosuvastatin
III
Crestor
2003
AstraZeneca
Submitted in 2003
pitavastatin
III
Livalo
2003
Kowa KK /
Sankyo KK
2003
Livalo
Kowa KK /
Sankyo KK
3. Statin products approved in Japan
All formulations of the statin products registered in Japan by June 2004
are listed in Table 5 below. Included are a comprehensive profile of each
product's approval and market entry timeline, as well as relevant medical,
regulatory, formulation and therapeutic remarks on the product. The
formulations are grouped by brand and the year of approval, arranged
alphabetically.
Table 2. Approval classification of the prescription medicinal products in
Japan
Class
Description
1
Medicines with new active ingredients
2
New combination medicines excluding medicines
Class 7-2 and trivial combinations
3
Medicines with new route of administration
4
Medicines with new indications
5
Medicines with new dosage forms
6
Medicines with new doses
7
Medicines with additional dosage forms: excluding
the medicines Class 5
7-2
Medicines with similar formulations
8
Miscellaneous
Table 3. Approval statistics of statin products in Japan
Generic Name /
Drug Candidate
Approved in
Japan -
n (% of total
Statins)
Approval Classification - Number in each
approval class (% of total Statins)
Class 1 Class 7 Class 7-2 Class 8
Additional
Formulation -
n (Other than
Tablet e.g.
granules)
Approval in July
2003 - n (% of total
Statins; Class One
Approval Date)
Atorvastatin Calcium Hydrate
1(1.96)
1(1.96) - - - -
-
- (May 2000)
Fluvastatin Sodium
2(3.92)
1(1.96) - - 1(1.96)
-
- (June 2003)
Pitavastatin Calcium
2(3.92)
1(1.96) - - 1(1.96)
-
- (Sept. 2003)
Pravastatin Sodium
28(54.9)
1(1.96) 1(1.96) 20(39.2) 6(11.8)
2 (granules)
27 (52.9; Sept
2001)
Simvastatin
18(35.3)
1(1.96) - 12(23.5) 5(9.80)
-
17 (33.3; Nov. 1991)
Total
51(100)
5(9.80) 1(1.96) 32(64.7) 13(23.5)
44 (86.2)
Graph 1. Approval share by type of statins
Graph 2. Approval share by approval class
Table 4. Alphabetical list of statin products approved in Japan
1. Alsetin
2. Amel Pravastatin Na
3. Amel Simvastatin
4. Cholerit
5. KN Pravastatin Na
6. KN Pravastatin Na
7. Liduc M
8. Lipitor
9. Lipoblock
10. Lipodown
11. Lipodown
12. Lipokoban
13. Lipo-off
14. Lipovas
15. Lipovatol
16. Lipozart
17. Livalo
18. Livalo
19. Lochol
20. Lochol
21. Maibastan
22. Meek Simvastatin
23. Meek Simvastatin
24. Mevalation
25. Mevalation
26. Mevalect
27. Mevalect
28. Mevalect
29. Mevalocut
30. Mevalotin (Tablet & Granules)
31. Mevan
32. Mevarich
33. Mevarich
34. Mevasrolin
35. Mevastan
36. Mevatorte (Tablet & Granules)
37. Mindorotin
38. Ohara Simvastatin
39. Ohara Simvastatin
40. Ohara Simvastatin
41. Pravalon
42. Pravamate
43. Pravastan
44. Pravastan
45. Pravastatin Sodium
46. Pravatin
47. Ramian
48. Simvamerck
49. Sinstatin
50. Sinstatin
51. Tatsuplamin
Table 5. Individual statin products approved in Japan
1. ALSETIN Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
ALSETIN
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00302000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG-CoA Reductase
Inhibitor -
Dyslipidemia Medicine
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(1st revision, new format)
Prescription Medicine
July 2003
July 2003
Product information continues on the next page
1. ALSETIN Tablets
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Pravastatin sodium 5mg;
10mg Additives:
magnesium stearate;
trace additives:
hydroxycellulose, D-
mannitol, ferric oxide
Chemical Formula: C23H35NaO7
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Alsetin 5mg, Tablets of 100 1,200
1,400 (PTP (Press through packing));
500 (Bottled packaging)
Alsetin 10mg, Tablets of 100, 600,
700, 1,200 (PTP packaging)
500 (Bottled packaging)
5mg: Diameter - 6.5mm; Weight - 90
mg; Thickness - 2.2mm Comments:
White tablet; 10mg: Diameter -
7.5mm; Weight - 140mg; Thickness -
2.5mm; Comments: White with
minute red line dividing half the
tablet
5mg 10mg
Manufacturer &
Marketing Agent:
Pacific
Pharmaceutical
Industries K.K.
16-29 Marunouchi 2
Chome, Chuo-ku,
Nagoya
2. AMEL PRAVASTATIN Na 5mg/10mg Tablets
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
AMEL PRAVASTATIN Na
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
(15AM)358
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(2nd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
2. AMEL PRAVASTATIN Na 5mg/10mg Tablets
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Effective ingredient in 1
tablet: 5mg/10mg of
pravastatin sodium
Additives: Anhydrous
lactose, microcystalline
hydroxypropylcellulose,
maize starch, talc,
hydroxypropylcellulose,
calcium stearate
C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
5mg of Pravastatin Na: 100, 700,
1,000 tablets (PTP & bottled packing)
10mg of Pravastatin Na: 100, 700,
1,000 tablets (PTP)), 500 (bottled)
Tablet Form: Round with half line on
one side, pink/red.
Size: 7.5mm, 2.5mm, 140mg weight
Manufacturer &
Marketing Agent:
Kyowa Yakuhin K.K.,
5-13-9, Nishi-
Nakashima,
Yodogawa-ku, Osaka-
City
3. AMEL SIMVASTATIN Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
AMEL SIMVASTATIN
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
(15AM)355
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG CoA Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(2nd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
3. AMEL SIMVASTATIN Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
One tablet, contains 5 mg
of simvastatin;
Excipients: lactose,
microcrystalline
cellulose,
hydroxypropylcellulose,
citric acid, magnesium
stearate magnesium,
anhydrous silicic acid,
butylhydroxyanisol
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethyl]-1-naphtyl-2,2-dimethylbutanoate;
100 tablets (PTP), 500 tablets (foil ),
700 tablets (PTP), 1,000 tablets
(PTP)
White with one side as a two division
line; Size: diameter 6.5mm;
thickness 2.4mm; weight 100mg
Manufacturer &
Marketing Agent:
Kyowa
Pharmaceutical Co.
Ltd.
5-13-9, Nishi-
Nakashima,
Yodogawa-ku, Osaka
4. CHOLERIT Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
CHOLERIT
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00337
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG CoA Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
January 2002
(5th Revision)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
4. CHOLERIT Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Cholerit 10mg contains 10
mg of pravastatin sodium
per tablet.
Also contains lactose,
maize starch,
hydroxypropylcellulose,
magnesium stearate,
ferric oxide as additives
Chemical Formula: C23H35NaO7;
Chemical Name: sodium(+)-(3R,5R)-3,5-
Dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate;
Cholerit 5 mg: 100 tablets (10 tablet
× 10), 500 tablets (10 tablet × 50)
(PTP)
Cholerit 10 mg: 100 tablets (10
tablet × 10), 500 tablets (10 tablet ×
50) (PTP)
Cholerit 10 mg are red tablets
marked with a line on one side.
Diameter 8.0 mm; thickness 2.4 mm
Manufacturer &
Marketing Agent:
Fusou Yakuhin Kogyo
K.K.
7-10,1-chome,Syudo-
Cho, Osaka
5. KN PRAVASTATIN Na 5/10 Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
KN PRAVASTATIN Na
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
(15AM)299
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(2nd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
5. KN PRAVASTATIN Na 5/10 Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Effective ingredient in 1
tablet: 5mg/10mg of
pravastatin sodium
Additives: D-mannitol,
crystalline cellulose,
modified starch,
magnesium stearate
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
KN Pravastatin Na Tablets 5mg: 100,
700, 1,000 tablets (PTP) & 1000
(bottled)
KN Pravastatin Na Tablets 10mg: 100,
700, 1,000 tablets (PTP), 500
(bottled)
Round white tablet; Size: 6.6mm,
2.2mm, 90mg weight
Manufacturer &
Marketing Agent:
Kobayashi Chemical
K.K. 26-17, 2-Chome,
Ichihime, Kanadu-
Cho, Sakai-gun, Fukui
6. KN PRAVASTATIN Na 5/10 Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
KN PRAVASTATIN Na
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
(15AM)299
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(2nd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
6. KN PRAVASTATIN Na 5/10 Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Effective ingredient in 1
tablet: 5mg/10mg of
pravastatin sodium
Additives: D-mannitol,
crystalline cellulose,
modified starch,
magnesium stearate
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
KN Pravastatin Na Tablets 5mg: 100,
700, 1,000 tablets (PTP) & 1000
(bottled)
KN Pravastatin Na Tablets 10mg: 100,
700, 1,000 tablets (PTP)), 500
(bottled)
Round white tablet: 6.6mm, 2.2mm,
90mg weight
Manufacturer &
Marketing Agent:
Kobayashi Chemical
K.K. 26-17, 2-Chome,
Ichihime, Kanadu-
Cho, Sakai-gun, Fukui
7. LIDUC M 10 Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
LIDUC M (r)
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00255000
Class 7-2
Hyperlipidemia
Familial Hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(2nd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
7. LIDUC M 10 Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Liduc M 10mg tablet
contains: pravastatin
sodium 10mg. Additives:
anhydrous citric acid
powder, ferric oxide,
dimethylpolysiloxane
(clinical grade), refined
stevia extract, maize
starch, fractionated
polyvinylalcohol, D-
mannitol and l-menthol
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Liduc M 10mg:
100 and 1000 tablets (PTP)
Liduc M 10mg: Pink tablet a side line,
Diameter 9.5mm, Thickness 3.9mm,
Weight 280mg
Manufacturer:
San Nova K.K. 3038-2,
Serada, Ojima-machi,
Nitta-gun, Gunma
Marketing Agent:
Elmed Ezai K.K. 3-23-
5, Higashi-Ikebukuro,
Toshima-ku, Tokyo
8. LIPITOR 5mg/10mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
LIPITOR(r)
Atorvastatin Calcium Hydrate
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
May 2000
21200AMZ00158
Class 1
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
August 2003
(10th Edition)
Prescription Medicine
May 2000
May 2000
Product Information continues on the next page
8. LIPITOR 5mg/10mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Lipitor 5mg tablet
contains: atorvastatin
calcium hydrate 5.42mg
(5.0mg as atorvastatin),
lactose, crystal cellulose,
sublimed calcium
carbonate,
croscarmellose sodium,
polysolvent 80,
hydroxypropylcellulose,
magnesium stearate,
hydroxypropylmethylcellu
lose, macrogol, titanium
oxide, talc, ferric oxide;
Lipitor 10mg tablet
contains: atorvastatin
calcium hydrate 10.84mg
(10.0mg as atorvastatin),
lactose, crystal cellulose,
sublimed calcium
carbonate,
croscarmellose sodium,
polysolvent 80,
hydroxypropylcellulose,
magnesium stearate,
hydroxypropylmethylcellu
lose, macrogol, titanium
oxide, talc
Chemical Formula: C66H68CaF2N4O10・3H2O;
Chemical Name: (-)-Monocalcium bis {[3R,5R）-
7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-
phenylcarbamoyl-1H-pyrrol-1-yl]-3,5-
dihydroxyheptanoate}trihydrate
Lipitor 5mg (PTP): 100 tablets、140
（14 tablets x 10）, 500 tablets.
Lipitor 10.0mg (PTP): 100 tablets,
140 (14 tablets × 10), 500 tablets、
700 (14 tablets × 50), 1000 tablets
Lipitor 10.0mg (Bottled): 500 tablets
Lipitor 5mg: Very thin pink film
coated tablet, Diameter 5.6mm,
Thickness 2.7mm, Weight 72mg
Lipitor 10mg: White tablet, Diameter
6.1mm, Thickness 2.7mm, Weight
88mg
Manufacturer:
Yamanouchi Seiyaku
K.K. 2-3-11,
Nihonbashi-honcho,
Chuo-ku, Tokyo
Marketing Agent:
Pfizer K.K. 3-22-7,
Yoyogi, Shibuya-ku,
Tokyo
9. LIPOBLOCK 5 Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
LIPOBLOCK
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00278000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor -
Dyslipidemia Medicine
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(2nd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
9. LIPOBLOCK 5 Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Lipoblock 5 tablet
contains: simvastatin
5.0mg. Additives: lactose,
cellulose,
hydroxypropylcellulose,
butylhydroxyanisol, citric
acid, magnesium stearate
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethyl]-1-naphthyl 2,2-dimethylbutanoate
Lipoblock 5:
PTP: 100,140, 700 and 1000 tablets
Bottled: 500 tablets
Lipoblock 5: White with one side
line, Diameter 6.35mm, Thickness
2.4mm, Weight 100mg
Manufacturer &
Marketing Agent:
Towa Yakuhin K.K. 2-
11, Shinbashi-cho,
Kadoma-city, Osaka
10. LIPODOWN 5 Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
LIPODOWN
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00374000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor -
Dyslipidemia Medicine
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
October 2003
(3rd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
10. LIPODOWN 5 Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Lipodown 5 tablet
contains: simvastatin
5.0mg. Additives: citric
acid, anhydrous silicilic
acid, magnesium
stearate, maize starch,
lactose,
hydroxyprpylcellulose,
butyhydroxyanisol
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethyl]-1-naphthyl 2,2-dimethylbutanoate
Lipodown 5:
PTP: 100 (10 tablets × 10), 500 (10
tablets × 50), 700 (14 tablets × 50)
Lipodown 5: White odorless tablet
with one side line, Diameter 6.5mm,
Thickness 2.4mm, Weight 100mg
Manufacturer:
Medisa Shinyaku K.K.
15-9, 4-Chome,
Nihonbashi-honcho,
Chuo-ku, Tokyo
Marketing Agent:
Asahi Kasei Pharma
K.K. 9-1, Kanda-
mitoshiro-cho,
Chiyoda-ku, Tokyo
11. LIPODOWN 5 Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
LIPODOWN
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00374000
Class 8
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor -
Dyslipidemia Medicine
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
October 2003
(3rd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
11. LIPODOWN 5 Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Lipodown 5 tablet
contains: simvastatin
5.0mg. Additives: citric
acid, anhydrous silicilic
acid, magnesium
stearate, maize starch,
lactose,
hydroxyprpylcellulose,
butyhydroxyanisol
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethyl]-1-naphthyl 2,2-dimethylbutanoate
Lipodown 5:
PTP: 100 (10 tablets × 10), 700 (14
tablets × 50), 1000 (10 tablets x 100)
Lipodown 5: White with one side
line, Diameter 6.5mm, Thickness
2.4mm, Weight 100mg
Manufacturer:
Medisa Shinyaku K.K.
15-9, 4-Chome,
Nihonbashi-honcho,
Chuo-ku, Tokyo
Marketing Agent:
Sawai Seiyaku K.K. 4-
25, 1-chome,
Akagawa, Asahi-ku,
Osaka-city
12. LIPOKOBAN Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
LIPOKOBAN
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00408000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor -
Dyslipidemia Medicine
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003
(2nd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
12. LIPOKOBAN Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Lipokoban 5 tablet
contains: simvastatin
5.0mg. Additives:
Lactose, maize starch,
microcrystalline
cellulose, citric acid,
crospovidone,
hydroxypropylcellulose,
magnesium stearate
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-
2-yl]ethyl]-1-naphthyl 2,2-dimethylbutanoate
Lipokoban tablet:
100 tablets(10 tablets ×10; PTP)
500 tablets (10 tablets × 50; PTP)
500 tablets（bottled）
700 tablets (14 tablets × 50; PTP)
Lipokoban tablet: White with one
side line, Diameter 6.5mm, Thickness
2.3mm, Weight 100mg
Manufacturer:
Kobayashi Yakugaku
Kogyo K.K. 4-2, 3-
chome, Shimo-
meguro, Meguro-ku,
Tokyo
Marketing Agent:
Noppon Iyakuhin
Kogyo K.K. 6-21, 1-
chome, Sougawa,
Toyama-city, Toyama
13. LIPO-OFF 5 Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
LIPO-OFF
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00407000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor -
Dyslipidemia Medicine
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003
(2nd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
13. LIPO-OFF 5 Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Lipo-off 5 tablet contains:
simvastatin 5.0mg.
Additives: Lactose, maize
starch, microcrystalline
cellulose, citric acid,
crospovidone,
hydroxypropylcellulose,
magnesium stearate
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethyl]-1-naphthyl 2,2-dimethylbutanoate
Lipo-off 5:
100 (10 tablets ×10; PTP)
500 (10 tablets × 50; PTP)
500 tablets (bottled)
700 (14 tablets × 50; PTP)
Lipo-off 5: White with one side line,
Diameter 6.5mm, Thickness 2.3mm,
Weight 100mg
Manufacturer &
Marketing Agent:
Nippon Iyakuhin Ko-
gyo K.K. 6-21, 1-
chome, Sougawa,
Toyama-city, Toyama
14. LIPOVAS 5/10/20 Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
LIPOVAS(r)
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
November 1991
20300AMZ00735000
Lipovas 5
June 2002
21300AMZ00847000
Lipovas 10, 20
Class 1
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor -
Dyslipidemia Medicine
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
February 2004
(12th Edition)
Prescription Medicine
November 1991
Lipovas 5
June 2002
Lipovas 10, 20
December 1991
Lipovas 5
June 2002
Lipovas 10, 20
Product Information continues on the next page
14. LIPOVAS 5/10/20 Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Lipovas 5, 10 & 20 tablets
contain: simvastatin
5.0mg, 10.0mg & 20.0mg
respectively; Additives:
Lactose, cellulose,
processed starch,
hydrolyzed gelatin,
crospovidone, citric acid,
BHA, magnesium stearate
Chemical Formula: C25H38O5;
Chemical Name:(+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethyl]-1-naphthyl 2,2-dimethylbutanoate
Lipovas 5: 100 (10 tablets × 10),
500 (10 tablets × 50),
700 (14 tablets × 50),
1,000 (10 tablets × 100) (PTP); 500
tablets (Bottled)
Lipovas 10: 100 (10 tablets × 10),
500 (10 tablets × 50), 700 (14 tablets
× 50), 1,000 (10 tablets × 100) PTP
Lipovas 20: 28 (14 tablets × 2), 100
(10 tablets × 10), 500 (10 tablets ×
50),
700 (14 tablets × 50) PTP
Lipovas 5: White with one side line,
Diameter 6.4mm, Thickness 2.4mm:
Lipovas 10: White with one side line,
Diameter 8.0mm, Thickness 3.0mm:
Lipovas 20: White with one side line,
Length 14.0mm, Width 7.5mm,
Thickness 4.6mm:
Manufacturer &
Marketing Agent:
Banyu Yakuhin K.K. 2-
2-3, Nihonbashi-
honcho, Chu-o-ku,
Tokyo
15. LIPOVATOL 5 Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
LIPOVATOL
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00278000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor -
Dyslipidemia Medicine
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(2nd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
15. LIPOVATOL 5 Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Lipovatol 5 tablet
contains: simvastatin
5.0mg. Additives:
sucrose, alpha-starch,
cellulose, crospovidone,
citric acid,
hydroxypropylcellulose,
anhydrous silicilic acid,
BHA, magnesium stearate
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethyl]-1-naphthyl 2,2-dimethylbutanoate
Lipovatol 5:
PTP: 100, 500 and 1000 tablets
Bottled: 500 tablets
Lipodown 5: White with one side
line, Diameter 6.5mm, Thickness
2.35mm, Weight 100mg
Manufacturer &
Marketing Agent:
Toyo Pharma K.K.
287-1, Shimocho,
Moroe-machi,
Kanazawa
16. LIPOZART 5 Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
LIPOZART
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00416000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor -
Dyslipidemia Medicine
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(Newly Revised 1st
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
16. LIPOZART 5 Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Lipozart 5 tablet
contains: simvastatin
5.0mg; Additives:
Carmellose calcium,
microcrystalline
cellulose, magnesium
stearate, lactose,
hydroxypropylcellulose,
butylhydroxyanisol
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-
2-yl]ethyl]-1-naphthyl 2,2-dimethylbutanoate
Lipozart 5:
100, 600, 700, and 1,200 tablets
(PTP), 500 (bottled)
Lipozart 5: White with one side line,
Diameter 6.5mm, Thickness 2.3mm,
Weight 100mg
Manufacturer &
Marketing Agent:
Yaiyo Yakuhin Kogyo
K.K. 16-29 2-Chome,
Marunouchi, Naka-ku,
Nagoya-city
17. LIVALO 1mg/2mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
LIVALO(r)
Pitavastatin Calcium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
September 2003
21500AMZ00459
Class 1
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
September 2003
(2nd Edition)
Prescription Medicine
September 2003
September 2003
Product Information continues on the next page
17. LIVALO 1mg/2mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Livalo 1mg tablet
contains: pitavastatin
calcium 1mg. Additives:
lactose,
hydroxypropylcellulose,
hydroxypropylmethylcellu
lose, magnesium alumina
meta-citrate, magnesium
stearate, triethyl citrate,
silicon dioxide, titanium
oxide, Carnauba Wax
Livalo 2mg tablet
contains: pitavastatin
calcium 1mg. Additives:
lactose,
hydroxypropylcellulose,
hydroxypropylmethylcellu
lose, magnesium alumina
meta-citrate, magnesium
stearate, triethyl citrate,
silicon dioxide, titanium
oxide, Carnauba Wax
Chemical Formula: C50H46CaF2N2O8;
Chemical Name: (+)-Monocalcium bis{(3R,5S,6E)-
7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-
3,5-dihydroxy-6-heptenoate}
Livalo 1mg (PTP Packaging)：100
tablets, 140（14 tablets ×10）, 500
tablets
Livalo 2mg (PTP Packaging)：100
tablets, 140（14 tablets × 10）, 500
tablets、700（14 tablets × 50）,
1000 tablets
Livalo 2mg (Bottled): 500 tablets
Livalo 1mg: White film coated tablet,
Diameter 6.2mm, Thickness 2.6mm,
Weight 85mg
Livalo 2mg: White film coated tablet,
Diameter 7.2mm, Thickness 3.0mm,
Weight 127mg
Manufacturer:
Kowa K.K. 6-29, 3-
Chome, Nishiki, Naka-
ku, Nagoya-shi
Marketing Agent:
Sankyo K.K. 3-5-1
Nihonbashi-Honcho,
Chuo-ku, Tokyo
18. LIVALO 1mg/2mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
LIVALO(r)
Pitavastatin Calcium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
September 2003
21500AMZ00459
Class 8
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
September 2003
(2nd Edition)
Prescription Medicine
September 2003
September 2003
Product Information continues on the next page
18. LIVALO 1mg/2mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Livalo 1mg tablet
contains: pitavastatin
calcium 1mg; Additives:
lactose,
hydroxypropylcellulose,
hydroxypropylmethylcellu
lose, magnesium alumina
meta-citrate, magnesium
stearate, triethyl citrate,
silicon dioxide, titanium
oxide, Carnauba
Wax
Livalo 2mg tablet
contains: pitavastatin
calcium 2mg. Additives:
lactose,
hydroxypropylcellulose,
hydroxypropylmethylcellu
lose, magnesium alumina
meta-citrate, magnesium
stearate, triethyl citrate,
silicon dioxide, titanium
oxide, Carnauba
Wax
Chemical Formula: C50H46CaF2N2O8;
Chemical Name: (+)-Monocalcium bis{(3R,5S,6E)-
7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-
3,5-dihydroxy-6-heptenoate}
Livalo 1mg (PTP): 100 tablets、140
（14 tablets ×10）, 500 tablets
Livalo 2mg (PTP): 100 tablets、140
（14 tablets × 10）, 500 tablets、700
（14 tablets × 50）, 1000 tablets
Livalo 2mg (Bottled): 500 tablets
Livalo 1mg: White film coated tablet,
Diameter 6.2mm, Thickness 2.6mm,
Weight 85mg
Livalo 2mg: White film coated tablet,
Diameter 7.2mm, Thickness 3.0mm,
Weight 127mg
Manufacturer &
Marketing Agent:
Kowa K.K. 6-29, 3-
Chome, Nishiki, Naka-
ku, Nagoya-shi
19. LOCHOL 10mg/20mg/30mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
LOCHOL
Fluvastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
June 2003
21500AMZ00035000
LOCHOL 10mg
June 2003
21500AMZ00036000
LOCHOL 20mg
June 2003
21500AMZ00037000
LOCHOL 30mg
Class 1
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003 (2nd Edition)
Prescription Medicine
June 2003
June 2003
Product Information continues on the next page
19. LOCHOL 10mg/20mg/30mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Lochol 10mg, 20mg &
30mg tablet contains:
fluvastatin sodium
10.53mg, 21.06mg &
31.59mg (as 10.0mg,
20.0mg & 30.0mg
fluvastatin) respectively.
Additives: sodium
hydrogen carbonate,
calcium carbonate,
cellulose, carmellose
calcium, talc, magnesium
stearate,
hydroxypropylmethylcellu
lose, macrogol, titanium
oxide, ferric oxide
Chemical Formula: C24H25FNNaO4;
Chemical Name: (±)-(3RS,5SR,6E)-Sodium-7-[3-
(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-
yl]-3,5-dihydroxy-6-heptenoate
Lochol 10mg:
PTP: 100 (10 tablets × 10), 500 (10
tablets × 50)
Lochol 20mg:
PTP: 100 (10 tablets × 10), 500 (10
tablets × 50), 700 (14 tablets × 50),
1,000 (10 tablets × 100)
Plastic bottle: 500 tablets
Lochol 30mg:
PTP: 100 (10 tablets × 10), 500 (10
tablets × 50)
Manufacturer:
Nippon Ciba Geigy
K.K. 4-17-30, Nishi-
Azabu, Minato-ku,
Tokyo
Marketing Agent:
Tanabe Seiyaku K.K.
2-10, 3-chome, Dosyo-
machi, Chuo-ku, Saka-
city
Product Information continues on the next page
19. LOCHOL 10mg/20mg/30mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Lochol 10mg, 20mg &
30mg tablet contains:
fluvastatin sodium
10.53mg, 21.06mg &
31.59mg (as 10.0mg,
20.0mg & 30.0mg
fluvastatin) respectively.
Additives: sodium
hydrogen carbonate,
calcium carbonate,
cellulose, carmellose
calcium, talc, magnesium
stearate,
hydroxypropylmethylcellu
lose, macrogol, titanium
oxide, ferric oxide
Chemical Formula: C24H25FNNaO4;
Chemical Name: (±)-(3RS,5SR,6E)-Sodium-7-[3-
(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-
yl]-3,5-dihydroxy-6-heptenoate
Lochol 10mg: Buff filmed coated
tablet, Diameter 5.7mm, Thickness
2.4mm, Weight 66mg
Lochol 20mg tablet: Buff filmed
coated tablet, Diameter 6.7mm,
Thickness 3.4mm, Weight 129mg
Lochol 30mg tablet: Buff filmed
coated tablet, Diameter 7.7mm,
Thickness 3.8mm, Weight 192mg
Manufacturer:
Nippon Ciba Geigy
K.K. 4-17-30, Nishi-
Azabu, Minato-ku,
Tokyo
Marketing Agent:
Tanabe Seiyaku K.K.
2-10, 3-chome, Dosyo-
machi, Chuo-ku, Saka-
city
20. LOCHOL 10mg/20mg/30mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
LOCHOL
Fluvastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
June 2003
21500AMZ00035000
LOCHOL 10mg
June 2003
21500AMZ00036000
LOCHOL 20mg
June 2003
21500AMZ00037000
LOCHOL 30mg
Class 8
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003
(2nd Edition)
Prescription Medicine
June 2003
June 2003
Product Information continues on the next page
20. LOCHOL 10mg/20mg/30mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Lochol 10mg, 20mg &
30mg tablet contains:
fluvastatin sodium
10.53mg, 21.06mg &
31.59mg (as 10.0mg,
20.0mg & 30.0mg
fluvastatin) respectively.
Additives: sodium
hydrogen carbonate,
calcium carbonate,
cellulose, carmellose
calcium, talc, magnesium
stearate,
hydroxypropylmethylcellu
lose, macrogol, titanium
oxide, ferric oxide
Chemical Formula: C24H25FNNaO4;
Chemical Name: (±)-(3RS,5SR,6E)-Sodium-7-[3-
(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-
yl]-3,5-dihydroxy-6-heptenoate
Lochol 10mg:
PTP: 100 (10 tablets × 10), 500 (10
tablets × 50)
Lochol 20mg:
PTP: 100 (10 tablets × 10), 500 (10
tablets × 50), 700 (14 tablets × 50),
1,000 (10 tablets × 100)
Individual & bottled: 500 tablets
Lochol 30mg:
PTP: 100 (10 tablets × 10), 500 (10
tablets × 50)
Manufacturer:
Nippon Ciba Geigy
K.K. 4-17-30, Nishi-
Azabu, Minato-ku,
Tokyo
Marketing Agent:
Novartis Pharma K.K.
4-17-30, Nishi-azabu,
Minato-ku, Tokyo
Product Information continues on the next page
20. LOCHOL 10mg/20mg/30mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Lochol 10mg, 20mg &
30mg tablet contains:
fluvastatin sodium
10.53mg, 21.06mg &
31.59mg (as 10.0mg,
20.0mg & 30.0mg
fluvastatin) respectively.
Additives: sodium
hydrogen carbonate,
calcium carbonate,
cellulose, carmellose
calcium, talc, magnesium
stearate,
hydroxypropylmethylcellu
lose, macrogol, titanium
oxide, ferric oxide
Chemical Formula: C24H25FNNaO4;
Chemical Name: (±)-(3RS,5SR,6E)-Sodium-7-[3-
(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-
yl]-3,5-dihydroxy-6-heptenoate
Lochol 10mg: Buff filmed coated
tablet, Diameter 5.7mm, Thickness
2.4mm, Weight 66mg
Lochol 20mg: Buff filmed coated
tablet, Diameter 6.7mm, Thickness
3.4mm, Weight 129mg
Lochol 30mg: Buff filmed coated
tablet, Diameter 7.7mm, Thickness
3.8mm, Weight 192mg
Manufacturer:
Nippon Ciba Geigy
K.K. 4-17-30, Nishi-
Azabu, Minato-ku,
Tokyo
Marketing Agent:
Novartis Pharma K.K.
4-17-30, Nishi-azabu,
Minato-ku, Tokyo
21. MAIBASTAN 5mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MAIBASTAN
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00363
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(1st Newly Revised
Edition; Precautionary
Prescription Clause
Added)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
21. MAIBASTAN 5mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Each tablet contains 5mg
or 10mg as pravastatin
sodium.
Additives: D-mannitol,
hydroxypropylcellulose,
silicic anhydride,
magnesium stearate,
ferric oxide
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Maibastan 5mg: 100 tablets, 140
tablets, 700 tablets, 1000 tablets
(PTP)
Maibastan 5mg Tablets: 1000 tablets
(Bottled)
Maibastan 10mg: 100 tablets, 140
tablets, 700 tablets, 1000 tablets
(PTP)
Maibastan 10mg Tablets: 500 tablets
(Bottled)
Maibastan 5mg Tablet: White,
diameter 6.5mm, thickness 2.2mm,
weight 90mg
Maibastan 10mg Tablet: Pinkish
tablet with a mid-line, diameter
7.5mm, thickness 2.6mm , weight
140mg
Manufacturer &
Marketing Agent:
Tohwa Yakuhin K.K.
2-11, Shinbashi-Cho,
Kasadoma-city, Osaka
22. MEEK SIMVASTATIN Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MEEK SIMVASTATIN
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
(15AM)296
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG CoA Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(1st Newly Revised
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
22. MEEK SIMVASTATIN Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
One tablet contains 5mg
of simvastatin;
Excipients: lactose,
microcrystalline
cellulose, anhydrous
calcium hydrogen
phosphate,
hydroxypropylated starch,
aspartame (containing L -
phenylalanine), citrus oil,
butyl hydroxyanisol,
magnesium stearate
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethyl]-1-naphtyl-2,2-dimethylbutanoate;
Meek Simvastatin 5mg: 100, 280 and
500 tablets (PTP)
White with one side as a two division
line; Size: diameter 7.1mm;
thickness 2.8mm; weight 140mg
Marketing Agent:
Meiji Seika Co. Ltd.
4-16 Kyobashi 2-
chome, Chuo-ku,
Tokyo 104-8002
Manufacturer:
Kobayashi Kako K.K.
26-17, 2-Chome,
Ichihime, Kanadu-
Cho, Sakai-gun, Fukui,
919-0621
23. MEEK SIMVASTATIN Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MEEK SIMVASTATIN
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
(15AM)296
Class 8
Hyperlipidemia, Familial
hypercholesterolemia
HMG CoA Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(1st Newly Revised
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
23. MEEK SIMVASTATIN Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
One tablet, contains 5mg
of simvastatin;
Excipients: Lactose,
microcrystalline
cellulose, anhydrous
calcium hydrogen
phosphate,
hydroxypropylated starch,
aspartame (containing L -
phenylalanine), citrus oil,
butyl hydroxyanisol,
magnesium stearate
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethyl]-1-naphtyl-2,2-dimethylbutanoate;
Meek Simvastatin 5mg: 100, 280 and
500 tablets (PTP)
White with one side as a two division
line; Size: diameter 7.1mm;
thickness 2.8mm; weight 140mg
Manufacturer &
Marketing Agent
Kobayashi Kako K.K.
26-17, 2-Chome,
Ichihime, Kanadu-
Cho, Sakai-gun, Fukui
919-0621
24. MEVALATION 5mg/10mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MEVALATION
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00238000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(2nd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
24. MEVALATION 5mg/10mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Mevalation 5mg tablet
contains: pravastatin
sodium 5mg; Additives:
lactose, cellulose,
carboxymethylated starch
sodium salt, calcium
stearate; Mevalation
10mg tablet contains:
pravastatin sodium 10mg.
Additives: lactose,
cellulose,
carboxymethylated starch
sodium salt, ferric oxide,
calcium stearate
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Mevalation 5mg: Tablets (PTP) in lots
of 100, 700, 1000 and 500 (Bottled)
Mevalation 10mg: Tablets (PTP) in
lots of 100, 700, 1000 and 500
(Bottled)
Mevalation 5mg: White tablet,
Diameter 6.0mm, Thickness 2.4mm,
Weight c.a. 90mg;
Mevatorte 10mg: Pink tablet with
one side line, Diameter 7.5mm,
Thickness 2.8mm, Weight 140mg;
Manufacturer &
Marketing Agent:
Choseido Seiyaku K.K.
92 Kou, Kokufu-cho,
Tokushima-city,
Tokushima
25. MEVALATION 5mg/10mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MEVALATION
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00238
Class 8
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(2nd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
25. MEVALATION 5mg/10mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Mevalation 5mg tablet
contains: pravastatin
sodium 5mg. Additives:
lactose, cellulose,
carboxymethylated starch
sodium salt, calcium
stearate; Mevalation
10mg tablet contains:
pravastatin sodium 10mg.
Additives: lactose,
cellulose,
carboxymethylated starch
sodium salt, ferric oxide,
calcium stearate
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Mevalation 5mg: Tablets (PTP) in lots
of 100, 700, 1000 and 500 (Bottled)
Mevalation 10mg: Tablets (PTP) in
lots of 100, 700, 1000 and 500
(Bottled)
Mevalation 5mg: White tablet,
Diameter 6.0mm, Thickness 2.4mm,
Weight c.a. 90mg;
Mevatorte 10mg: Pink tablet with
one side line, Diameter 7.5mm,
Thickness 2.8mm, Weight 140mg;
Manufacturer:
Choseido Seiyaku K.K.
92 Kou, Kokufu-cho,
Tokushima-city,
Tokushima
Marketing Agent:
Merck Hoei Co., Ltd.
6-8 Honmachi 2-
Chome, Chuo-ku,
Osaka
26. MEVALECT 5mg/10mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MEVALECT
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00263000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003
(1st Newly Revised
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
26. MEVALECT 5mg/10mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Mevalect 5mg tablet
contains: pravastatin
sodium 5mg. Additives:
Lactose, microcrystalline
cellulose, magnesium
aluminum maleate,
hydroxypropylcellulose,
croscarmellose sodium,
magnesium stearate;
Mevalect 10mg tablet
contains: pravastatin
sodium 10mg. Additives:
lactose, microcrystalline
cellulose, magnesium
aluminum maleate,
hydroxypropylcellulose,
croscarmellose sodium,
ferric oxide, magnesium
stearate
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-〔(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-〔(S)-2-methylbutyryloxy〕-1,2,6,7,8,8a-
hexahydro-1-naphthyl〕heptanoate
Mevalect 5mg：100 (PTP)、1000 (PTP)
Mevalect 10mg：100 (PTP), 1000
(PTP)
Mevalect 5mg: White tablet,
Diameter 6.5mm, Thickness 2.2mm,
Weight 90mg;
Mevalect 10mg: Pink tablet with one
side line, Diameter 7.5mm, Thickness
2.6mm, Weight 140mg;
Manufacturer &
Marketing Agent:
Toryo-Yakuhin Kogyo
K.K. 1-10-1,
Yurakucho, Chiyoda-
ku, Tokyo
27. MEVALECT 5mg/10mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MEVALECT
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00263000
Class 8
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003
(1st Newly Revised
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
27. MEVALECT 5mg/10mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Mevalect 5mg tablet
contains: pravastatin
sodium 5mg. Additives:
lactose, microcrystalline
cellulose, magnesium
aluminum maleate,
hydroxypropylcellulose,
croscarmellose sodium,
magnesium stearate;
Mevalect 10mg tablet
contains: pravastatin
sodium 10mg. Additives:
lactose, microcrystalline
cellulose, magnesium
aluminum maleate,
hydroxypropylcellulose,
croscarmellose sodium,
ferric oxide, magnesium
stearate
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Mevalect 5mg：100 (PTP)、1000 (PTP)
Mevalect 10mg：100 (PTP), 1000
(PTP)
Mevalect 5mg: White tablet,
Diameter 6.5mm, Thickness 2.2mm,
Weight 90mg;
Mevalect 10mg: Pink tablet with one
side line, Diameter 7.5mm, Thickness
2.6mm, Weight 140mg;
Manufacturer:
Toryo Yakuhin Kogyo
K.K. 1-10-1,
Yurakucho, Chiyoda-
ku, Tokyo
Marketing Agent:
Nippon Hekisaru K.K.
1-10, 3-chome, Mita,
Minato-ku, Tokyo
Product Information continues on the next page
28. MEVALECT 5mg/10mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MEVALECT
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00263000
Class 8
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003
(1st Newly Revised
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
28. MEVALECT 5mg/10mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Mevalect 5mg tablet
contains: pravastatin
sodium 5mg. Additives:
lactose, microcrystalline
cellulose, magnesium
aluminum maleate,
hydroxypropylcellulose,
croscarmellose sodium,
magnesium stearate;
Mevalect 10mg tablet
contains: pravastatin
sodium 10mg. Additives:
lactose, microcrystalline
cellulose, magnesium
aluminum maleate,
hydroxypropylcellulose,
croscarmellose sodium,
ferric oxide, magnesium
stearate
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Mevalect 5mg：100 (PTP)、1000 (PTP)
Mevalect 10mg： 100 (PTP), 1000
(PTP)
Mevalect 5mg: White tablet,
Diameter 6.5mm, Thickness 2.2mm,
Weight 90mg;
Mevalect 10mg: Pink tablet with one
side line, Diameter 7.5mm, Thickness
2.6mm, Weight 140mg;
Manufacturer:
Toryo Yakuhin Kogyo
K.K. 1-10-1, Yuraku-
cho, Chiyoda-ku,
Tokyo
Marketing Agent:
Nippon Garen K.K. 12-
18, 2-chome,
Kawaguchi,
Kawaguchi-city,
Saitama
29. MEVALOCUT 5mg/10mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MEVALOCUT
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00263000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003
(1st Newly Revised
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
29. MEVALOCUT 5mg/10mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Mevalocut 5mg tablet
contains: pravastatin
sodium 5mg; Additives:
Lactose, microcrystalline
cellulose, magnesium
aluminum maleate,
hydroxypropylcellulose,
croscarmellose sodium,
magnesium stearate;
Mevalocut 10mg tablet
contains: pravastatin
sodium 10mg; Additives:
Lactose, microcrystalline
cellulose, magnesium
aluminum maleate,
hydroxypropylcellulose,
croscarmellose sodium,
ferric oxide, magnesium
stearate
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl] heptanoate
Mevalocut 5mg：100, 500, 1000 (PTP);
500 (bottled)
Mevalocut 10mg：100, 500, 1000
(PTP); 500 (bottled)
Mevalocut 5mg: White tablet,
Diameter 6.6mm, Thickness 2.1mm,
Weight 90mg;
Mevalocut 10mg: Pink tablet with
one side line, Diameter 7.6mm,
Thickness 2.5mm, Weight 140mg;
Manufacturer &
Marketing Agent:
Toyo Pharma K.K.
287-1, Shimocho,
Moroe-machi,
Kanazawa-shi,
Ishikawa
30. MEVALOTIN 5mg/10mg Tablet, 0.5%/1.0% Granules
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MEVALOTIN(r)
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
September 2001
21300AMZ00549
Class 7
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
October 2003
(8th Newly Revised
Edition)
Prescription Medicine
September 2001
October 1989
Product Information continues on the next page
30. MEVALOTIN 5mg/10mg Tablet, 0.5%/1.0% Granules
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Mevalotin 5mg tablet
contains: pravastatin
sodium 5mg; Additives:
hydroxypropylcellulose,
low molecular weight
microcrystalline
hydroxypropylcellulose,
magnesium aluminium
silicate, lactose,
magnesium stearate;
Mevalotin 10mg tablet
contains: pravastatin
sodium 10mg; Additives:
hydroxypropylcellulose,
low molecular weight
microcrystalline
hydroxypropylcellulose,
magnesium aluminium
silicate, microcrytalline
cellulose, lactose, ferric
oxide, magnesium
stearate
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Mevalotin 5mg: 100 tablets, 140 (10 x
14 tablets), 500 tablets, 700 (50 x 14
tablets)- PTP; 1,000 tablets
(PTP/Bottled)
Mevalotin 10mg: 100 tablets, 140 (10
x 14 tablets), 300 tablets, 700 （50 x
14 tablets), 1000 tablets - PTP; 500
tablets (PTP/Bottled)
Mevalotin 0.5% granules：100g
(bottled), 1g×504 sachets
Mevalotin 5mg: White tablet,
Diameter 6.5mm, Thickness 2.1mm,
Weight 90mg;
Mevalotin 10mg: Pink tablet with one
side line, Diameter 7.5mm, Thickness
2.6mm, Weight 140mg;
Manufacturer &
Marketing Agent:
Sankyo K.K., 3-5-1
Honmachi,
Nihonbashi, Chuo-ku,
Tokyo
Product Information continues on the next page
30. MEVALOTIN 5mg/10mg Tablet, 0.5%/1.0% Granules
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
1.0g of Mevalotin 0.5%
granules contains:
pravastatin sodium 5mg;
hydroxypropylcellulose,
low molecular weight
microcrystalline
hydroxypropylcellulose,
magnesium aluminium
silicate, lactose,
magnesium stearate; 1.0g
of Mevalotin 1% granules
contains: pravastatin
sodium 10mg;
hydroxypropylcellulose,
low molecular weight
microcrystalline
hydroxypropylcellulose,
magnesium aluminium
silicate, microcrytalline
cellulose, lactose, ferric
oxide, magnesium
stearate
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Mevalotin 0.5% granules：100g
(bottled), 1g×504 sachets
Mevalotin 1% granules： 100g
(bottled)
Manufacturer &
Marketing Agent:
Sankyo K.K., 3-5-1
Honmachi,
Nihonbashi, Chuo-ku,
Tokyo
31. MEVAN 5mg/10mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MEVAN
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21300AMZ00549
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor;
Hypercholesterolemia
Treatment
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003
(1st Newly Revised
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
31. MEVAN 5mg/10mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Mevan 5mg tablet
contains: pravastatin
sodium 5mg; Additives:
lactose, cellulose,
hydroxypropylcellulose,
magnesium stearate;
Mevan 10mg tablet
contains: pravastatin
sodium 10mg; Additives:
lactose, cellulose,
hydroxypropylcellulose,
ferric oxide, magnesium
stearate
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Mevan 5mg:
100 (10 tablets x 10; PTP), 500 (10
tablets x 50; PTP), 500 tablets
(bottled), 700 (14 tablets x 50; PTP)
Mevan 10mg:
100 (10 tablets x 10; PTP), 140 (14
tablets x 10; PTP), 500 (10 tablets x
50; PTP), 500 tablets (bottled)
700 (14 tablets x 50; PTP)
Mevan 5mg: White tablet, Diameter
6.0mm, Thickness 2.5mm, Weight
90mg;
Mevan 10mg: Pink tablet with one
side line, Diameter 7.0mm, Thickness
2.9mm, Weight 140mg;
Manufacturer &
Marketing Agent:
Nippon Iyakuhin Kogyo
K.K. 6-21, 1-chome,
Sougawa, Toyama-
city, Toyama
32. MEVARICH 5mg/10mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MEVARICH
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00253000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(1st Newly Revised
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
32. MEVARICH 5mg/10mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Mevarich 5mg tablet
contains: pravastatin
sodium 5mg. Additives:
Lactose, maize starch,
microcrystalline
cellulose, sodium
hydrogen phosphate,
carmellose calcium, ferric
oxide, magnesium
stearate; Mevalation
10mg tablet contains:
pravastatin sodium 5mg.
Additives: lactose,
cellulose,
carboxymethylated starch
sodium salt, ferric oxide,
calcium stearate
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Mevarich 5mg: 100 (10 PTP sheets of
10 tablets), 500 (50 PTP sheets of 10
tablets), 500 tablets, 700 (50 PTP
sheets of 14 tablets), 1000 (100 PTP
sheets of 10 tablets)
Mevarich 10mg: 100 (10 PTP sheets
of 10 tablets), 500 (50 PTP sheets of
10 tablets), 500 tablets, 700 (50 PTP
sheets of 14 tablets), 1000 (100 PTP
sheets of 10 tablets)
Mevarich 5mg: White tablet,
Diameter 6.0mm, Thickness 1.9mm,
Weight c.a. 70mg;
Mevarich 10mg: Pink tablet with one
side line, Diameter 7.0mm, Thickness
2.6mm, Weight 120mg;
Manufacturer:
Nisshin Seiyaku K.K.
1331 Aza Fujidan, O-
aza Syouge, Tendou-
city, Yamagata
Marketing Agent:
Kaken Seiyaku K.K.
28-8. 2-Chome,
Honkomagome,
Bunjyo-ku, Tokyo
33. MEVARICH 5mg/10mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MEVARICH
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00253000
Class 8
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003
(1st Newly Revised
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
33. MEVARICH 5mg/10mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Mevarich 5mg tablet
contains: pravastatin
sodium 5mg. Additives:
lactose, maize starch,
microcrystalline
cellulose, sodium
hydrogen phosphate,
carmellose calcium, ferric
oxide, magnesium
stearate; Mevalation
10mg tablet contains:
pravastatin sodium 10mg.
Additives: lactose,
cellulose,
carboxymethylated starch
sodium salt, ferric oxide,
calcium stearate
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Mevarich 5mg: 100 (10x10 tablets),
500 (50x10 tablets), 500 tablets, 700
(50x14 tablets), 1000 (100x10
tablets) (PTP), 1000 tablets (Bottled)
Mevarich 10mg: 100 (10x10 tablets),
500 (50x10 tablets), 500 tablets, 700
(50x14 tablets), 1000 (100x10
tablets), 1000 tablets (Bottled)
Mevarich 5mg: White tablet,
Diameter 6.0mm, Thickness 1.9mm,
Weight c.a. 70mg;
Mevarich 10mg: Pink tablet with one
side line, Diameter 7.0mm, Thickness
2.6mm, Weight 120mg;
Manufacturer &
Marketing Agent:
Nisshin Seiyaku K.K.
1331 Aza Fujidan, O-
aza Syouge, Tendou-
city, Yamagata
34. MEVASROLIN 10mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MEVASROLIN
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00350000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003
(1st Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
34. MEVASROLIN 10mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Each tablet contains:
pravastatin sodium 10mg.
Additives: lactose,
microcrystalline
cellulose, croscarmellose
sodium, magnesium
stearate, ferric oxide,
yellow ferric oxide
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Mevasrolin 10mg tablet: 100, 500
Tablets
Mevasrolin 10mg tablet is pink in
color and has a line on one side with
the identifying symbol TSU755.
Diameter 7.5mm、Thickness 2.4mm,
Weight 140mg
Manufacturer &
Marketing Agent:
Turuhara Seiyaku K.K.
16-1, 1 Chome,
Toyoshima-kita,
Ikeda-city, Osaka
35. MEVASTAN 10 Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MEVASTAN
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00265
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(2nd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
35. MEVASTAN 10 Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Each tablet contains:
pravastatin sodium 10mg;
Additives: aspartame,
yellow ferric oxide,
polyplasdone XL, calcium
stearate, ferric oxide,
Japan Pharmacopoeia
(JP) grade magnesium
stearate, JP grade D-
mannitol, flavoring
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Mevastan 10mg: 100 (10 tablets x
10), 500 tablets (10 tablets x 50)
(PTP)
Mevastan 10mg Tablet: Pink,
Diameter 8.0mm, Thickness 3.6mm,
Weight 180mg
Manufacturer:
Mohann-Yakuhin
Laboratory K.K.,
4-13-5, Nishi-sugamo,
Toshima-ku, Tokyo
Marketing Agent:
Kyowa Hakkou Kogyo
K.K. 1-6-1, Otemachi,
Chiyoda-ku, Tokyo
36. MEVATORTE 5/10 Tablet & Granules
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MEVATORTE
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00329
Class 8
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
October 2003
(3rd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
36. MEVATORTE 5/10 Tablet & Granules
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Each tablet of Mevatorte
5 contains: pravastatin
sodium 5mg; Additives:
lactose, cellulose,
hydroxypropylcellulose,
hydroxypropylmethylcellu
lose, magnesium
stearate; Mevatorte 10:
pravastatin sodium 10mg;
Additives: Lactose,
cellulose,
hydroxypropylcellulose,
hydroxypropylmethylcellu
lose, ferric oxide,
magnesium stearate; &
Mevatorte Granules:
pravastatin sodium 10mg,
hydroxypropylcellulose,
hydroxypropylmethylcellu
lose, ferric oxide, talc,
magnesium stearate.
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Mevatorte 5/10mg 100 tablets; PTP
(10 tablets x 10); 5/10 mg 700
tablets; PTP (14 tablets x 50); 5/10
mg 1000 tablets; PTP (10 tablets x
100); 5/10 mg 500 tablets (Bottled)
Mevatorte 1% 100g Granules
Mevatorte 5mg: White tablet,
Diameter 6.5mm, Thickness 2.2mm,
Weight c.a. 90mg;
Mevatorte 10mg: Pink tablet with
one side line, Diameter 7.5mm,
Thickness 2.6mm, Weight c.a.
140mg;
Mevatorte Granules: Pink
Manufacturer &
Marketing Agent:
Taisyo Yakuhin Kogyo
K.K. 3, Ohara-Ichiba,
Kouka-chou, Kouka-
gun, Shiga
37. MINDOROTIN 5mg/10mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
MINDOROTIN
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00316000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(2nd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
37. MINDOROTIN 5mg/10mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Each 5mg tablet contains
5mg as pravastatin
sodium. Additives:
microcrystalline
cellulose, lactose,
calcium stearate, sodium
lauryl sulfate, sodium
phosphate dibasic,
croscarmellose sodium,
povidone, light anhydrous
silicic acid, magnesium
stearate.
Each 10mg tablet
contains 10mg as
pravastatin sodium.
Additives:
microcrystalline
cellulose, lactose,
calcium stearate, sodium
lauryl sulfate, sodium
phosphate dibasic,
croscarmellose sodium,
povidone, ferric oxide,
light anhydrous silicic
acid, magnesium
stearate.
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Mindorotin 5mg: 100 tablets, 500
tablets (PTP); 1000 tablets (bottled)
Mindorotin 10mg: 100 tablets, 500
tablets (PTP); 500 tablets (bottled)
Mindorotin 5mg Tablet: White,
Diameter 6.0mm, Thickness 2.4mm,
Weight 90mg
Mindorotin 10mg Tablet: Pink,
Diameter 7.0mm、Thickness 2.4mm,
Weight 100mg
Manufacturer &
Marketing Agent:
Maruko Yakuhin K.K.
5-17, 1-chome,
Kodama, Nishi-ku,
Nagoya
38. OHARA SIMVASTATIN Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
OHARA SIMVASTATIN
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00327000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG CoA Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003
(1st Newly Revised
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
38. OHARA SIMVASTATIN Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
One tablet, contains 5mg
of simvastatin
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethyl]-1-naphtyl-2,2-dimethylbutanoate;
Ohara Simvastatin 5mg: (PTP), 100
tablets ( 10 tablet × 10 ) 500 tablets
( 10 tablet × 50 ), 700 tablets (14
tablet × 50 )
White with a line marking on one
side; Size: diameter 6.5mm;
thickness 2.3mm; weight 100mg
Manufacturer:
Yoshindo K. K.
3697-8, Haginoshima,
Fuchu-machi, Nei-
gun, Toyama
Marketing Agent:
Nippon Chemiphar
Co., Ltd.
2-2-3, Iwamoto-cho,
Chiyoda-ku, Tokyo,
101-8678
39. OHARA SIMVASTATIN Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
OHARA SIMVASTATIN
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00327000
Class 8
Hyperlipidemia, Familial hypercholes
terolemia
HMG CoA Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003
(1st Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
39. OHARA SIMVASTATIN Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
One tablet, contains 5mg
of simvastatin
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethyl]-1-naphtyl-2,2-dimethylbutanoate
Ohara Simvastatin 5mg: (PTP), 100
tablets ( 10 tablet × 10 ) 500 tablets
( 10 tablet × 50 ), 700 tablets ( 14
tablet × 50 )
White with a line marking on one
side; Size: diameter 6.5mm;
thickness 2.3mm; weight 100mg
Manufacturer:
Ohara Chemical
Industries, Ltd.
43-1 Oharaichiba
Koka-Cho, Koka-Gun
Shiga, 520-3433
Marketing Agent:
Takata Seiyaku
13-10, 2-chome,
Trigoe, Taito-ku
Tokyo
40. OHARA SIMVASTATIN Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
OHARA SIMVASTATIN
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00327000
Class 8
Hyperlipidemia
Familial hypercholesterolemia
HMG CoA Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003
(1st Newly Revised
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
40. OHARA SIMVASTATIN Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
One tablet, contains 5mg
of simvastatin
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethyl]-1-naphtyl-2,2-dimethylbutanoate
Ohara Simvastatin 5mg: (PTP), 100
tablets ( 10 tablet × 10 ) 500 tablets
( 10 tablet × 50 ), 700 tablets ( 14
tablet × 50 )
White with a line marking on one
side; Size: diameter 6.5mm;
thickness 2.3mm; weight 100mg
Manufacturer &
Marketing Agent:
Ohara Chemical
Industries, Ltd.
43-1 Oharaichiba
Koka-Cho, Koka-Gun
Shiga, 520-3433
41. PRAVALON 5/10 Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
PRAVALON
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00177000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(1st Newly Revised
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
41. PRAVALON 5/10 Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Effective ingredient in 1
5mg tablet: 5mg of
pravastatin sodium.
Additives: Lactose, maize
starch,
hydroxypropylcellulose,
magnesium stearate
Effective ingredient in 1
10mg tablet: 10mg of
pravastatin sodium.
Additives: Lactose, maize
starch,
hydroxypropylcellulose,
ferric oxide, magnesium
stearate
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Pravalon 5
PTP: 56 tablets (14 tablet × 4),100
tablets (10 tablet × 10), 500 tablets
(10 tablet × 50), 700 tablets (14
tablet × 50), Bottled: 1,000 tablets
Pravalon 10
PTP: 56 tablets (14 tablet × 4),100
tablets (10 tablet × 10), 500 tablets
(10 tablet × 50), 700 tablets (14
tablet × 50), Bottled: 500 tablets
10mg Tablet: Pinkish red, half line on
one side, odorless slightly bitter
tasting, 8.0mm diameter, 2.4mm
thickness & 150mg weight
Marketing Agent:
Teikoku Medic K. K.
9-19 Tosawamachi,
Nihonbashi, Chuo-ku,
Tokyo
Manufacturer:
Daito K.K.
326 Yokamachi,
Toyama-shi, Toyama
939-8221
42. PRAVAMATE 5mg/10mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
PRAVAMATE
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00325000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003
(1st Newly Revised
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
42. PRAVAMATE 5mg/10mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Effective ingredient in 1
5mg tablet: 5mg of
pravastatin sodium
Effective ingredient in 1
10mg tablet: 10mg of
pravastatin sodium
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Pravamate 5mg
PTP Packaging: 100 tablets (10
tablets × 10), 500 (10 tablet x 50),
700 tablets (14 tablet × 50), 1000
tablets (10 tablet x 100)
Bottled Packaging: 1000 tablets
Pravamate 10mg
PTP Packaging: 100 tablets (10
tablets × 10), 300 (10 tablets x 30),
500 (10 tablets x 50), 700 tablets (14
tablet × 50), 1000 tablets (10 tablets
x 100), Bottled Packaging: 500
tablets
5mg Tablet: 6.5mm diameter, 2.4mm
thickness & 100mg weight
10mg Tablet: 7.5mm diameter,
2.4mm thickness & 130mg weight
Manufacturer &
Marketing Agent:
Ohara Chemical
Industries Ltd.
43-1 Oharaichiba
Kouka-cho, Kouka-
Gun Shiga, 520-3433
43. PRAVASTAN Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
PRAVASTAN
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00154000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(1st Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
43. PRAVASTAN Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Effective ingredient in 1
5mg tablet: 5mg of
pravastatin sodium.
Additives: sodium
caramellose, magnesium
stearate, cellulose,
lactose;
Effective ingredient in 1
10mg tablet: 10mg of
pravastatin sodium.
Additives: Yellow ferric
oxide, caramellose
sodium, ferric oxide,
magnesium stearate,
cellulose, lactose
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Pravastan 5mg
PTP Packaging: 100 tablets (10
tablets × 10), 500 tablets (10 tablet ×
50), 700 tablets (14 tablet × 50)
Bottled Packaging : 1000 tablets
Pravastan 10mg
PTP Packaging: 100 tablets (10
tablets × 10), 500 tablets (10 tablet ×
50), 700 tablets (14 tablet × 50)
Bottled Packaging : 500 tablets
White tablet
5 mg: 6.5mm diameter, 2.0mm
thickness & 90mg weight
10mg: 7.5mm diameter, 3.0mm
thickness & 140mg weight
Manufacturer &
Marketing Agent:
Japan Yakuhin Kogyo
K.K. 2-3
Ishimotomachi 2-
Chome, Chiyoda-ku,
Tokyo
44. PRAVASTAN 5/10 Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
PRAVASTAN
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00154000
Class 8
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(1st Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
44. PRAVASTAN 5/10 Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Effective ingredient in 1
5mg tablet: 5mg of
pravastatin sodium.
Additives: sodium
caramellose, magnesium
stearate, cellulose,
lactose
Effective ingredient in 1
10mg tablet: 10mg of
pravastatin sodium.
Additives: Yellow ferric
oxide, caramellose
sodium, ferric oxide,
magnesium stearate,
cellulose, lactose
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Pravastan 5 mg
PTP Packaging: 100 tablets (10
tablets × 10), 500 tablets (10 tablet ×
50), 700 tablets (14 tablet × 50)
Bottled Packaging: 1000 tablets
Pravastan 10 mg
PTP Packaging: 100 tablets (10
tablets × 10), 500 tablets (10 tablet ×
50), 700 tablets (14 tablet × 50)
Bottled Packaging: 500 tablets
5mg: 6.5mm diameter, 2.0mm
thickness & 90mg weight
10mg: 7.5mm diameter, 3.0mm
thickness & 140mg weight
Manufacturer:
Japan Yakuhin Kogyo
K.K. 2-3
Iwamotomachi 2-
Chome, Chiyoda-ku,
Tokyo, 101-8678
Marketing Agent:
Chemiphar K.K.
2-2-3, Iwamoto-cho,
Chiyoda-ku, Tokyo,
101-8678
45. PRAVASTATIN SODIUM 5mg/10mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
PRAVASTATIN SODIUM
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00281
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(1st Newly Revised
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
45. PRAVASTATIN SODIUM 5mg/10mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Effective ingredient in 1
tablet: 5mg/10mg of
pravastatin sodium
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyrylox]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Pravastatin Sodium 5mg
PTP Packaging: 100 tablets (10
tablets × 10), 500 tablets (10 tablets
× 50), 700 tablets (14 tablets × 50)
Bottled Packaging : 500 tablets
Pravastatin Sodium 10 mg
PTP Packaging: 100 tablets (10
tablets × 10), 500 tablets (10 tablet ×
50), 700 tablets (14 tablet × 50)
Bottled Packaging : 500 tablets
Odourless white tablet, slightly bitter
tasting.
(No tablet size specification)
Manufacturer &
Marketing Agent:
Yoshindo K.K, 3697-8,
Haginoshima, Fuchu-
machi , Nei-gun,
Toyama
46. PRAVATIN 5/10 Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
PRAVATIN
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00354000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(2nd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
46. PRAVATIN 5/10 Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Effective ingredient in 1
5mg tablet: 5mg of
pravastatin sodium.
Additives: magnesium
stearate, lactose,
hydroxypropylcellulose,
meta-citric acid,
magnesium aluminate
Effective ingredient in 1
10mg tablet: 10mg of
pravastatin sodium
Additives: ferric oxide,
magnesium stearate,
lactose,
hydroxypropylcellulose,
meta-citric acid,
magnesium aluminate
Chemical Formula: C23H35NaO7;
Chemical Name: Sodium(+)-(3R,5R)-3,5-
dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1,2,6,7,8,8a-
hexahydro-1-naphthyl]heptanoate
Pravatin 5
PTP: 100 (10 tablets x 10), 700 (14
tablets x 50), 1000 (10 tablets x 100)
Bottled: 1000 tablets
Pravatin 10
PTP: 100 (10 tablets x 10), 700 (14
tablets x 50), 1000 (10 tablets x 100)
Bottled: 1000 tablets
5mg Tablet: 6.5mm diameter, 2.1mm
thickness & 85mg weight
10mg Tablet: 7.0mm diameter,
2.4mm thickness & 110mg weight
Manufacturer &
Marketing Agent:
Sawai Seiyaku K.K.
4-25, Akagawa 1-
chome, Asahi-ku,
Osaka 535-0005
47. RAMIAN 5mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
RAMIAN(r)
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00332000
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003
(2nd Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
47. RAMIAN 5mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
Ramian 5mg tablet
contains: simvastatin
5mg. Additives: citric
acid, microcrystalline
cellulose, magnesium
stearate, maize starch,
lactose,
hydroxypropylmethylcellu
lose 2910,
butylhydroxyanisol
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethyl]-1-naphthyl 2,2-dimethylbutanoate
Ramian 5mg:
100 (10 tablets x 10)
500 tablets (bottled)
1000 (10 tablets x 100)
Ramian 5mg: White tablet, Diameter
6.5mm, Thickness 2.3mm, Weight
100mg
Manufacturer:
Taisyo Yakuhin Kogyo
K.K. 3, Ohara-Ichiba,
Kouka-chou, Kouka-
gun, Shiga
Marketing Agent:
Teikoku Zouki Seiyaku
K.K. 5-1, 2-chome,
Shibaura, Minato-ku,
Tokyo
48. SIMVAMERCK Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
SIMVAMERCK
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00349
Class 7-2
Hyperlipidemia, Familial
hypercholesterolemia
HMG CoA Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(1st Newly Revised
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
48. SIMVAMERCK Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
One tablet, contains 5mg
of simvastatin;
Excipients: lactose,
hydropropylated starch,
sodium croscarmellose, t-
butylhydroxytoluene,
magnesium stearate
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethyl]-1-naphtyl-2,2-dimethylbutanoate
Simvamerck Tablet 5mg
Bottled: 500 tablets
PTP: 100 & 500 tablets
White with one side as a two division
line; Size: diameter 6.5mm;
thickness 2.3mm; weight 100mg
Manufacturer:
Mohann-Yakuhin
Laboratory K.K., 4-13-
5, Nishi-sugamo,
Toshima-ku, Tokyo
Marketing Agent:
Merck Hoei K.K.,
6-8 Honmachi 2-
Chome, Chuo-ku,
Osaka
49. SINSTATIN Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
SINSTATIN
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00280
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG CoA Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(1st Newly Revised
Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
49. SINSTATIN Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
1 tablet, contains 5mg of
simvastatin
as an additive, contains
butylhydroxyanisol
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethyl]-1-naphtyl-2,2-dimethylbutanoate
PTP: 100 (10 Tablets x 10), 500 (10
Tablets x 50), 700 (14 Tablets x 50)
Bottled: 500 Tablets
White with a line marking on one
side
Manufacturer &
Marketing Agent:
Yoshindo K.K.
3697-8, Ogishima,
Haginoshima, Fuchu-
machi , Nei-gun,
Toyama
50. SINSTATIN Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
SINSTATIN
Simvastatin
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00280
Class 8
Hyperlipidemia
Familial hypercholesterolemia
HMG CoA Reductase
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
July 2003
(1st Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
50. SINSTATIN Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
One tablet, contains 5mg
of simvastatin
as an additive, contains
butylhydroxyanisol
Chemical Formula: C25H38O5;
Chemical Name: (+)-(1S,3R,7S,8S,8aR)-
1,2,3,7,8,8a-Hexahydro-3,7-dimethyl-8-[2-
[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-
yl]ethyl]-1-naphtyl-2,2-dimethylbutanoate
White with a line marking on one
side; Size: diameter 6.0mm;
thickness 2.6mm; weight 100mg
Manufacturer:
Yoshindo K. K.
3697-8, Haginoshima,
Fuchu-machi , Nei-
gun, Toyama
Marketing Agent:
Nippon Chemiphar
Co., Ltd.
2-2-3, Iwamoto-cho,
Chiyoda-ku, Tokyo,
101-8678
51. TATSUPLAMIN 5mg/10mg Tablet
Brand
Generic Name
Japan Standard Commodity
Classification Number
Period for
Reexamination
TATSUPLAMIN
Pravastatin Sodium
872189
6 years
Approval Date/Number
Approval Classification
Approved Indication(s)
Therapeutic
Category
July 2003
21500AMZ00288000 (5mg)
21500AMZ00289000(10mg)
Class 7-2
Hyperlipidemia
Familial hypercholesterolemia
HMG Co-A Enzyme
Inhibitor
Package Insert Revision
Regulatory Classification(s)
Listing in the National Health
Insurance Price List
Market Launch in
Japan
June 2003(1st Newly
Revised Edition)
Prescription Medicine
July 2003
July 2003
Product Information continues on the next page
51. TATSUPLAMIN 5mg/10mg Tablet
Bulk Formulation
Chemical Characterization
Packaging & Formulation
Specification
Manufacturer/
Marketing Agent
One tablet, contains 5mg
or 10mg of pravastatin
sodium; Excipients:
hydroxypropylcellulose,
microcrystalline
hydroxypropylcellulose,
cellulose, magnesium
alumina silicate , lactose,
magnesium stearate
Chemical Formula: C23H35NaO7
Chemical Name: Sodium (+)-(3R, 5R)-3, 5-
dihydroxy-7-[(1S, 2S, 6S, 8S, 8aR)-6-hydroxy-2-
methyl-8-[(S)-2-methylbutyryloxy]-1, 2, 6, 7, 8,
8a-hexahydro-1-naphthyl] heptanoate
Tatsuplamin Tablet 5mg: 100 (PTP)
500 (PTP), 1000 (PTP & Bottled)
Tatsuplamin Tablet 10mg:
100 (PTP), 500 (PTP), 1000 (PTP &
Bottled)
Solid form: White crystalline solid
Tatsuplamin Tablet 5mg Size:
Diameter 6.5mm, Thickness 2.1mm,
Weight 90 mg;
Tatsuplamin Tablet 10mg Size:
Diameter 7.5mm, Thickness 2.6mm,
Weight 140mg
Manufacturer &
Marketing Agent:
Tasumi Kagaku K.K.,
406 3 Chome,
Hisayasu, Kanazawa,
Ishikawa, 921-8164
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www.jouhoukoukai.com
Kuroda M, Endo A., Inhibition of in vitro cholesterol synthesis by fatty acids. Biochim
Biophys Acta. 1976 Jan 18; 486(1): 70-81.
Endo, A., The discovery and development of HMG-CoA reductase inhibitors. Journal of
Lipid Research, 33, 1992, 1569-1582.
For examples of the strong cultural influence in the development of CNS drugs, see the
details in All in Japan: Triptans.
Statin pleiotropism refers to the non-lipid lowering effects, such as endothelial function,
inflammation, coagulation and plaque stability.
On the basis of the NHI reimbursement prices in 2003; in-house research.
Withdrawn from the market in 2001 - see more info.
Modified from the Attached Table 2-1, MHW, Pharmaceutical Affairs Bureau Notification
No. 698 dated May 30, 1980.
MHW, Pharmaceutical Affairs Bureau Notification No. 698 (May 30, 1980) describes nine different approval classifications of prescription
medicinal products in Japan however only those classifications relevant to the Statin class of medicines have been included here: Class 1 -
Medicines with new active ingredients; Class 7 - Medicines with additional dosage forms; Class 7-2 - Medicines with similar formulations;
Class 8 - Miscellaneous
July 2003 was when the Japan Patent for Mevalotin(r) expired
Mevalotin(r) and Mevatorte granules
Mevalotin(r) was commercially launched as early as October 1989, in September 2003 0.5%/1.0% Mevalotin(r) granules was approved as an
additional formulation (Class 7)
All in Japan Statins
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All in Japan Statins
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All in Japan Statins
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All in Japan Statins
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All in Japan Statins
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All in Japan Statins
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All in Japan Statins
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