All in Japan: Anti-cancers Enterprise-wide Use License - All
approved medicinal products
in Japan
ANTI-CANCERS
Table of Contents
1. Introduction 4
2. Key findings 5
3. Anti-cancer products approved in Japan 6
Table. 1 Anti-cancer products approved in Japan 6
1. Cyclophosphamide-based 6
2. Gemcitabine-based 12
3. Paclitaxel-based 13
4. Doxorubicin-based 15
5. Capecitabine-based 18
6. Trastuzumab-based 20
7. Gefitinib-based 22
8. Irinotecan-based 23
Disclaimer and Publisher Information
Note: The documents from the Japan Monitor gAll in Japanh 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.
All in Japan All in Japan All in Japan All in Japan 3. Anti-cancer products approved in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan All in Japan
ANTI-CANCER PRODUCTS IN JAPAN
1. Introduction
Although there are a number of medicinal products with primary or secondary oncology indications, those do not fall into a separate regulatory category.
The present report from the series All in Japan covers selected eight individual active substances: cyclophosphamide, gemcitabine, paclitaxel, doxorubicin, capecitabine, trastuzumab, gefitinib, irinotecan approved as medicinal products 1 in Japan, and described by the brand, maker/importer and marketer/distributor.
The selection of the active substances detailed herebelow is made on the basis of their approval and use in the other major pharmaceutical markets. Provided are the package inserts version (issued by the pharmaceutical manufacturers, importers or the entities commissioned to market the approved product), formulation, packages, indications, approved doses and schedules.
Future parts of the All in Japan: Anti-cancer Products series shall cover other classes of approved ant-cancer medicinal products, such as platinum-based compounds.
1 Under the Pharmaceutical Affairs Law of Japan (PAL) there are four categories of regulated medicinal products: drugs (pharmaceutical and biologicals), medical devices, quasi-drugs and cosmetics.
2. Key findings
Key Findings
The eight researched active substances were found to have a total of 17 products on the market
The products listed in Table 1 correspond to the product classes available in the other major markets of US and EU
There is one product (No. 4 in the Table 1) approved for marketing 2, however intended only for pharmacy sales, not for hospital or retail sales
The number of products based on the individual substances varies
The approved products include both brand and generic products
Additional information on the approved products is provided in the Remarks part of the Table 1, and in the footnotes and the endnotes of the Table 1.
2 Under the PAL regulations, to be permitted for marketing the approved medicinal products should be determined a National Health Insurance Tariff List price (reimbursement price)
1. Cyclophosphamide-based
1.1. Endoxan tablets
No.
Product
Approval info
Remarks
Generic
Brand
Maker / Marketer
PI version
Formulations
Package
1
cyclophosphamide
Endoxan P Tablets
Baxter Germany Co. tie-up /
Shionogi Seiyaku KK
August 2002
(8 revision)
50 mg tablets
PTP 100 tablets (10 x10)
Revised August 2002 (5th editionCrevision of precautions based on clerical notice)
Indication(s)
Alleviate subjective and objective symptoms of the following disease.
Multiple myeloma, malignant lymphoma, (Hodgkin disease, lymphosarcoma, reticulosarcoma), breast cancer, acute leukemia, polycythemia vera, lung cancer, nerve tumor (neuroblastoma, retinoblastoma), osteoncus.
For the following disease, it is necessary to combine with other anti-tumor drugs.
Chronic lymphatic leukemia, chronic myeloid leukemia, laryngeal cancer, stomach cancer, pancreas cancer, hepatoma, colon cancer, cervical cancer, corpus uteri carcinoma, ovarian cancer, orchioncus, villosity disease, (choriocarcinoma, destructive hydatidiform mole, hydatidiform mole), rhabdomyosarcoma, malignant melanoma.
Approved Dose(s) and Schedules
1. When not combing with other drugs
Normally, in adults, cyclophosphamide (anhydride conversion) 100-200 mg/day PO. Amount is subject to change according to age and symptoms.
2. When combing with other anti-tumor drugs
Conform to dosage of when not combining with other drugs.
1.2. Endoxan for injections
No.
Product
Approval info
Remarks
Generic
Brand
Maker / Marketer
PI version
Formulations
Package
2
cyclophosphamide
Endoxan for injections
Baxter Germany Co. tie-up / Shionogi Seiyaku KK
October 2003
(7 revision)
100 mg
10 vials
Revised October 2003 (7th edition, revised in factors such as efficacy, effect, composition due to partial change in drug import approval)
3
500 mg
1 vial
Indication(s)
1.
Alleviate subjective and objective symptoms of the following diseases:
Multiple myeloma, malignant lymphoma, (Hodgkin disease, lymphosarcoma, reticulosarcoma), breast cancer, acute leukemia, polycythemia vera, cervical cancer, corpus uteri carcinoma, ovarian cancer, nerve tumor (neuroblastoma, retinoblastoma), osteoncus.
For the following disease, it is necessary to combine with other anti-tumor drugs:
Chronic lymphatic leukemia, chronic myeloid leukemia, laryngeal cancer, stomach cancer, pancreas cancer, hepatoma, colon cancer, orchioncus, villosity disease, (choriocarcinoma, destructive hydatidiform mole, hydatidiform mole), rhabdomyosarcoma, malignant melanoma.
2.
Treatment prior to hemopoiesis stem cell transplant of following diseases:
Acute leukemia, chronic myeloid leukemia, osteomyelodysplasia syndrome, severe aplastic anemia, malignant lymphoma, heredity diseases (immunodeficiencies, congenital metabolism disorders and congenital blood diseases: Fanconi anemia, Wiskott-Aldrich syndrome, Hunter disease, etc.)
Precautions on efficacy /effect:
When applying to treatment prior to hemopoiesis stem cell transplant of heredity disease, administer with consideration to the patientfs status quo of treatment and risk/benefit of hemopoiesis stem cell transplant.
Approved Dose(s) and Schedules
1 Alleviate subjective and objective symptoms
(1) When not combining with other drugs
Normally, in adults, cyclophosphamide (anhydride conversion) 100 mg, OD, IV daily. If the patient is capable, increase the dose to 200 mg. The total amount will be 3000-8000 mg, if efficacy is admitted continue this as long as possible.
When leukocyte number decrease, administer once in 2-3 days, when it is under 1/2 of normal, stop dosage for a while, continue dosage after it is normal.
Intermittently, normally, in adults, 300-500 mg, 1-2 times/week, IV.
Inject or infuse intramuscular, intrathoracic or intratumoral, when necessary.
200-1000 mg/day, rapid or continuous intra-arterial instillation to perfusion of focus.
Or administer 1000-2000 mg/dose, regional perfusion by extracorporeal circulation.
Amount is subject to change according to age and symptoms.
(2) Combined with other anti-tumor drugs
Conform to dosage of when not combining with other drugs.
2. Prior treatment to hemopoiesis stem cell transplant
(1) Acute leukemia, chronic myelocytic leukemia, osteomyelodysplasia
Normally, in adults, cyclophosphamide (anhydride conversion) 60 mg/kg, OD, DIV over 2 to 3 hours for 2 consecutive days
(2) Severe aplastic anemia
Normally, in adults, cyclophosphamide (anhydride conversion) 50 mg/kg, OD, DIV over 2 to 3 hours for 4 consecutive days.
(3) Malignant lymphoma
Normally, in adults, cyclophosphamide (anhydride conversion) 50 mg/kg, OD, DIV over 2 to 3 hours for 4 consecutive days. Amount is subject to change according to combining drug.
(4) Heredity diseases (immunodeficiencies, congenital metabolism disorders and congenital blood diseases: Wiskott-Aldrich syndrome, Hunter disease, etc.)
Normally, cyclophosphamide (anhydride conversion) 50 mg/kg, OD, DIV over 2 to 3 hours for 4 consecutive days or 60 mg/kg OD, DIV over 2 to 3 hours for 2 consecutive days. Amount is subject to change according to combining drug.
For Fanconi anemia, total dosage amount should not excess 40 mg/kg (5-10 mg/kg for 4 days) since it is reported that the fragility of cell increase the toxicity related to transplant.
Preparation of injection
Dissolve cyclophosphamide (anhydride conversion) 100 mg (1 vial) with 5 mL physiological saline. When 500 mg (1 vial), dissolve with 25 mL physiologic saline.
Reference: do not use water for injection for it will cause hypotonicity of the solution.
1.3 Cyclophosphamide substance
No.
Product
Approval info
Remarks
Generic
Brand
Maker / Marketer
PI version
Formulations
Package
4
Cyclophos- phamide
-
-
-
1 g
Approved and priced as a substance only for pharmacy sale, not for hospital or retail sales
2. Gemcitabine-based
No.
Product
Approval info
Remarks
Generic
Brand
Maker / Marketer
PI version
Formulations
Package
5
gemcitabine
Gemzar injections
Nippon Ely Lilly KK
March 2004 (5 revision)
200 mg
Vials
6
1 g
Indication(s)
Non-small cell lung carcinoma, pancreas cancer
Approved Dose(s) and Schedules
1. Normally, in adults, Gemcitabine 1000 mg/m2, DIV over 30 min, once a week for 3 consecutive weeks and washout during the 4th week. Repeat this cycle. Amount subject to change according to age, symptoms or ADR.
2. Dissolve in more than 5 mL physiologic saline for 200 mg vial of gemcitabine and more than 25 mL for 1g vial.
3. Paclitaxel-based
No.
Product
Approval info
Remarks
Generic
Brand
Maker / Marketer
PI version
Formulations
Package
7
paclitaxel
Taxol Injections
Bristol Meyers KK /
Bristol Seiyaku KK
January 2004 (8 revision)
30 mg
5 mL vials
8
100 mg
16.7 mL vials
Indication(s)
Ovarian cancer, non-small cell lung carcinoma, breast cancer stomach cancer
Approved Dose(s) and Schedules
1. Normally, in adults, Paclitaxel 210 mg/m2 (surface area of body) OD, DIV over 3 hours, washout for at least 3 weeks. Repeat this cycle. Amount subject to change according to age and symptoms.
2. Dissolve Paclitaxel in 500 mL of 5% dextrose injection solution or physiologic saline, DIV 3 hours. Use inline-filter such as membrane filter under 0.22Ê. Saline (anhydride conversion) 100 mg (1 bottle) with 5 mL physiologic saline. When 500 mg (1 bottle), dissolve with 25 mL physiologic saline. Avoid applying substances that include DEHP [di-(2-ethylhexyl) phthalate] as plasticizer on the contacting area of drip kit and the drug.
3. In order to prevent serious hypersensitive reaction caused by the drug, prior administration is necessary. As prior administration, dexamethasone sodium phosphate injection solution (dexamethasone 20 mg) IV, once, 12-14 hours, and once,U-Vhours prior to administration of the drug, or once, 30 min prior to administration of the drug, diphenhydramine hydrochloride injection solution (diphenhydramine hydrochloride 50 mg) PO, once, 30 min prior to administration of the drug, ranitidine hydrochloride injection solution (ranitidine 50 mg) or famotidine for injection (famotidine 20 mg) IV, 30 min prior to administration of the drug.
Precautions on dosage
1. Observe change in amount of white blood cell and neutrophilic leukocyte, if WBC is under 4,000/mm3 or neutrohpilic leukocyte is under 2,000/mm3, postpone administration until marrow function recovery. When WBC is below 1,000/mm3 after administration of drug, decrease the next dosage.
Standard pattern for reduction: amount of dose
Normal amount: 210 mg/m2
1st step reduction: 180 mg/m2
2nd step reduction: 150 mg/m2
3rd step reduction: 135 mg/m2
When at serious neuropathy, consider to reduce the dosage from the next administration, conform to the reduction pattern of marrow suppression.
2.**For dilution of the drug is satiated, paclitaxel may precipitate as crystal, therefore, administer the drug through in-line filter using membrane filter under 0.22Ê.
4. Doxorubicin-based
No.
Product
Approval info
Remarks
Generic
Brand
Maker / Marketer
PI version
Formulations
Package
9
doxorubicin
Adriacin injections
Kyowa Hakko Kogyo KK
January 2004
(5 revision)
10 mg
10 vials
Indication(s)
Doxorubucin hydrochloride normal treatment
Alleviate the following subjective and objective symptoms
Malignant lymphoma, (histiocytic lymphoma, lymphosarcoma, Hodgkin disease), lung cancer, gastrointestinal cancer (stomach cancer, gallbladder cancer, cholangiocarcinoma, pancreas cancer, hepatoma, colon cancer, rectal carcinoma), breast cancer, bladder tumor, osteosarcoma.
Approved Dose(s) and Schedules
Malignant lymphoma, (histiocytic lymphoma, lymphosarcoma, Hodgkin disease), lung cancer, gastrointestinal cancer (stomach cancer, gallbladder cancer, cholangiocarcinoma, pancreas cancer, hepatoma, colon cancer, rectal carcinoma), breast cancer, osteosarcoma
1) Doxorubicin hydrochloride, 10 mg (0.2 mg/kg) (titer), dissolve in injection water or pharmacopoeial physiological saline, OD, IV one shot, 4-6 consecutive days, washout 7-10 days. Repeat this cycle for 2-3 times.
Doxorubicin hydrochloride
2) Doxorubicin hydrochloride 20 mg (0.4 mg/kg) (titer), dissolve in pharmacopoeial injection water or pharmacopoeial physiological saline, OD, IV one shot, for 2-3 days, washout for 7-10 days. Repeat this cycle for 2-3 times.
3) Doxorubicin hydrochloride 20-30 mg (0.4-0.6 mg/kg) (titer), dissolve in pharmacopoeial injection water or pharmacopoeial physiological saline, OD, IV one shot, for 3 days, washout for 18 days. Repeat this cycle for 2-3 times.
4) Total dose of Doxorubicin hydrochloride should be less than 500 mg/ m2 (titer).
Bladder tumor
5) Doxorubicin hydrochloride, 30-60 mg (titer), dissolve in 20-40 mL pharmacopoeial physiological saline to make 1-2 mg (titer)/mL, OD, daily or 2-3 times/week, intra-bladder.
Amount subject to change according to age and symptoms.
(Procedure of intra-bladder administration of Doxorubicin hydrochloride)
Drain urine by Nelaton catheter, after completely empting bladder, administer Doxorubicin hydrochloride, 30-60 mg (titer) dissolved in 20-40 mL pharmacopeial physiological saline to make 1-2 mgititerjsolution, through the Nelaton catheter. Maintain in bladder for 1-2 hours.
Efficacy/effect and dosage
**M-VAC treatment
Urothelial carcinoma
When combing methotrexate, vinblastine sulfate and cisplatin, normally, in adults, Dissolve doxorubicin hydrochloride in pharmacopoeial injection water or pharmacopoeial physiological saline, 30 mg (titer)/ m2 (surface area of body), IV injection.
Amount subject to change according to age and symptoms.
Standard dosage and administration
Administer methotrexate 30 mg/m2 on the 1st day, and on the 2nd day, administer vinblastine sulfate 3 mg/m2, doxorubicin hydrochloride 30 mg (titer)/m2 and cisplatin 70 mg/ m2, IV injection. On the 15th and 22nd day, methotrexate 30 mg/m2, and vinblastine sulfate 3 mg/m2, IV injection. Repeat this cycle every 4 weeks. The total amount of doxorubicin hydrochloride should be no more than 500 mg (titer)/m2.
5. Capecitabine-based
No.
Product
Approval info
Remarks
Generic
Brand
Maker / Marketer
PI version
Formulations
Package
10
capecitabine
Xeloda
Chugai Seiyaku KK
December 2003 (4 revision)
300 mg tablets
14 tablets PTP x 10
14 tablets PTP x 4
Indication(s)
Inoperable or recurrence of breast cancer
Approved Dose(s) and Schedules
Efficacy and precautions
1. Efficacy and safety of the drug on postoperative treatment are not established.
2. Single administration of the drug should be limited to deterioration or recurrence of chemotherapy that contain anthracycline anti-malignant tumor.
3. Efficacy and safety of initial chemotherapy of combined therapy is not established.
Dosage
Administer the following amount according to the surface area of body, BID, within 30 min after breakfast and dinner, PO, for 21 consecutive days, washout for 7 days. Repeat this cycle.
Surface area of body
Amount/dose
-1.31 m2
900 mg
1.31 m2 - 1.64 m2
1,200 mg
1.64 m2 -
1,500 mg
6. Trastuzumab-based
No.
Product
Approval info
Remarks
Generic
Brand
Maker / Marketer
PI version
Formulations
Package
11
trastuzumab
Herceptin for injections 60
Chugai Seiyaku KK
April 2005
(10th revision)
60 mg
Vials
1 vial pharma-
copeial injection water (7.2 mL) and 1 vial pharma-
copeial physiolo-
gical saline (250 mL) attached
12
Herceptin for injections 150
150 mg
Indication(s)
HER2 excess manifestation confirmed metastatic breast cancer
Efficacy and precautions
HER2 excess manifestation test to be performed by experienced pathologist or institution.
Approved Dose(s) and Schedules
1.
Normally, in adults, OD, trastuzumab 4 mg/kg (body weight) at initial administration, 2 mg/kg at 2nd administration, DIV over more than 90 min, 1 week dose interval.
2.
At the time of administration of the drug, Dissolve trastuzumab in the attached pharmacopoeial injection water 7.2 mL and when the concentration is 21 mg/mL, extract necessary amount with syringe, then immediately dilute with pharmacopoeial physiological saline 250 mL to DIV.
[Conversion formula per body weight]
Initial administration
Amount to extract (mL) = (body weight (kg) x 4 (mg/kg) / 21(mg/mL)/ 2nd and after administration
Amount to extract (mL) = (body weight (kg) x 2 (mg/kg)) / 21 (mg/mL)
(Standard extract amount is printed in the last part of package insert)
7. Gefitinib-based
No.
Product
Approval info
Remarks
Generic
Brand
Maker / Marketer
PI version
Formulations
Package
13
gefitinib
Iressa Tablets 250
AstraZeneca KK
March 2005
(11th revision)
Tablets 250 mg
PTP 14 tablets
Indication(s)
Inoperable or recurrence non-small cell lung carcinoma
Efficacy/effect and precautions
1. Efficacy and safety of the drug on chemotherapy and terminal therapy are not established.
2. Efficacy and safety of the drug on postoperative adjuvant are not established.
Approved Dose(s) and Schedules
Normally, in adult, Gefitinib, 250 mg OD, PO
Dosage and precautions
Many cases of achlorhydria among aged Japanese patients are reported. Therefore, after meal dosage is preferable. (Refer to gimportant basic cautionsh)
8. Irinotecan-based
8.1. Campto
No.
Product
Approval info
Remarks
Generic
Brand
Maker / Marketer
PI version
Formulations
Package
14
irinotecan
Campto injections
Yakult Honsha KK
April 2004 (6 revision)
40 mg
2 mL vials
15
100 mg
5 mL vials
Indication(s)
Small cell lung carcinoma, non-small cell lung carcinoma, cervical cancer, ovarian cancer, stomach cancer (inoperable or recurrence) colon/rectum cancer (inoperable or recurrence), breast cancer (inoperable or recurrence), squamous cell carcinoma, malignant lymphoma (non-Hodgkin lymphoma).
Approved Dose(s) and Schedules
1.
Select A for small cell lung carcinoma, non-small cell lung carcinoma, breast cancer (inoperable or recurrence), squamous cell carcinoma.
For cervical cancer, ovarian cancer stomach cancer (inoperable and recurrence) and colon/rectum cancer (inoperable or recurrence), select A or B.
For malignant lymphoma (non-Hodgkin lymphoma), select C.
Amount is subject to change according to age and symptoms.
Regimen 3 A: Normally, in adults, administer irinotecan hydrochloride, 100 mg/m2 OD, 1 week dose interval, for 3-4 times, DIV, washout for at least 2 weeks, repeat this cycle.
Regimen B: Normally, in adults, administer irinotecan hydrochloride, 150 mg/m2 OD, 2 week dose interval, for 2-3 times, DIV, washout for at least 3 weeks, repeat this cycle.
Regimen C: Normally, in adults, administer irinotecan hydrochloride, 40 mg/m2 OD, 3 consecutive days, every week for 2-3 times, DIV, washout for at least 2 weeks, repeat this cycle.
2.
As for Regimen A and B, mix the drug in more than 500 mL (according to the dose amount) of physiologic saline, dextrose in water or electrolyte balanced solution, DIV over more than 90 min. As for dosage C, mix the drug in more than 250 mL (according to the dose amount) physiologic saline, dextrose in water or electrolyte balanced solution, DIV over more than 60 min.
3 In this translation, gdosageh and gregimenh are used intermittently and with identical meaning, since both English terms correspond to a single Japanese character used in the original text.
8.2. Topotecin
No.
Product
Approval info
Remarks
Generic
Brand
Maker / Marketer
PI version
Formulations
Package
16
irinotecan
Topotecin injections
Dai-ichi Seiyaku KK / Yakult Honsha KK
April 2005 (7th revision) 4
40 mg
2 mL vials
17
100 mg
5 mL vials
Indication(s)
Approved Dose(s) and Schedules
Small cell lung carcinoma, non-small cell lung carcinoma, breast carcinoma (inoperable or recurrence) squamous cell carcinoma
1. For small cell lung carcinoma, non-small cell lung carcinoma, breast carcinoma (inoperable or recurrence) and squamous cell carcinoma, apply dosage regimen A.
Regimen A: Normally, in adults, 100 mg/m2 irinotecan hydrochloride, OD, DIV, 3-4 times with 1 week dose interval, washout for at least 2 weeks. Repeat this cycle. Amount is subject to change according age and symptoms.
As for regimen A, mix the drug in more than 500 mL (according to the dose amount) of physiologic saline, dextrose in water or electrolyte balanced solution, DIV over more than 90 min.
4 Revision in compliance to the amended Pharmaceutical Affairs Law (PAL) enforced on April 1, 2005.
2. Cervical cancer, ovarian cancer, stomach cancer (inoperable or recurrence) colon/rectum cancer (inoperable or recurrence)
Apply regimen A or B for cervical cancer, ovarian cancer, stomach cancer (inoperable or recurrence), colon/rectum cancer (inoperable or recurrence).
Regimen A: Normally, in adults, 100 mg/m2 irinotecan hydrochloride, OD, DIV, 3-4 times with 1 week dose interval, washout for at least 2 weeks. Repeat this cycle.
Regimen B: Normally, in adults, 150 mg/m2 irinotecan hydrochloride, OD, DIV, 3-4 times with 2 week dose interval, washout for at least 3 weeks. Repeat this cycle.
Amount is subject to change according to age and symptom.
As for regimen A and B, mix the drug in more than 500 mL (according to the dose amount) of physiologic saline, dextrose in water or electrolyte balanced solution, DIV over more than 90 min.
3. Malignant lymphoma (non-Hodgkin lymphoma)
Apply dosage C for malignant lymphoma (non-Hodgkin lymphoma)
Regimen C: Normally, in adults, administer 40 mg/m2 irinotecan hydrochloride, OD, DIV, for 3 consecutive days 2-3 times with 1 week dose interval, washout for at least 2 weeks. Repeat this cycle.
Amount is subject to change according to age and symptoms.
As for regimen C, mix the drug in more than 250 mL (according to the dose amount) of physiologic saline, dextrose in water or electrolyte balanced solution, DIV over more than 60 min.
Endnotes to Table 1
1. The Table 1 is designed to accommodate the larger contents of Indications/Approved Doses and Schedules parts for each product.
2. The formatting of the Indications/Approved Doses and Schedules parts resembles as closely as possible the formatting of the original Japanese documents
3. All original documents related to the approval of medicinal products by the Japanese authorities are only in Japanese, including their titles, table of contents and texts. Translation in English is provided here solely by the Jouhou Koukai Services. While utmost care has been taken both linguistically and organizationally to reflect into the English translation the language, abbreviations, professional jargon, style and conventions used in the original texts, no claims either expressed or implied are made for completeness and correctness. Some of the conventions used originate from legacy documents earlier translated to English under the supervision of the MHLW. The Japanese Government does not provide authorized (officially sanctioned) translations of its documents. The translations here are tentative. In a case of legal dispute, the original texts in Japanese will prevail.
4. All of the documents related to the approval of medicinal products contain very formal Japanese language. The style of the translation reflects in English the style of the originals.
5. The makers/importers and distributor/marketers are given with their transcribed Japanese names.
6. For further inquiries for clarification and in the cases of found or suspected errors, please email to regulatory@jouhoukoukai.com.
.
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Under the Pharmaceutical Affairs Law of Japan (PAL) there are four categories of regulated medicinal
products: drugs (pharmaceutical and biologicals), medical devices, quasi-drugs and cosmetics.
Under the PAL regulations, to be permitted for marketing the approved medicinal products should be
determined a National Health Insurance Tariff List price (reimbursement price)
Once daily.
Intravenous drip infusion.
Once daily.
Intravenous drip infusion.
In this translation, "dosage" and "regimen" are used intermittently and with identical meaning, since
both English terms correspond to a single Japanese character used in the original text. Urothelial tumors of the renal pelvis and ureter
Revision in compliance to the amended Pharmaceutical Affairs Law (PAL) enforced on April 1, 2005.
"Office Communication" is one type of the documents released by the Japanese Ministry of Health,
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All in Japan Anti-cancers
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