Generated Narrative: Composition compositionsimvastatin20jpi Language: ja Profile: Composition (ePI) identifier: https://spor.ema.europa.eu/rmswi//fcats34placeholder status: Final type: Package Leaflet date: 2002-08-01 13:28:17+0000 author: Organization Ohara Pharmaceutical Co., Ltd. title: simvastatin20 Package Leaflet - 150 mg for Intravenous Use Attesters - Mode Time * Official 2002-08-01 13:28:17+0000
simvastatin20 Package Leaflet - 150 mg for Intravenous Use
アロマターゼ阻害剤/閉経後乳癌治療剤
unavailable
2. 禁忌(次の患者には投与しないこと)
禁忌(次の患者には投与しないこと)
9. 特定の背景を有する患者に関する注意
特定の背景を有する患者に関する注意
16.6.1 腎機能障害患者における体内動態
16.6.2 肝機能障害患者における体内動態
17.1.4 海外大規模比較試験(第III相試験 術後補助療法)
17.1.6 非盲検無作為化比較試験(第II/III相試験 転移性乳癌に対する第一次 ホルモン療法)
Generated Narrative: Organization orgohara Profile: Organization (ePI) identifier: https://pmda-org-id/sim672212 (use: official, ) active: true type: Marketing authorisation holder name: Ohara Pharmaceutical Co., Ltd. Contacts - Address * 15 Nihonbashi Muromachi, Chuo-ku, Tokyo 8324(work)
15 Nihonbashi Muromachi, Chuo-ku, Tokyo 8324
Generated Narrative: RegulatedAuthorization authsimvastatin20 Profile: RegulatedAuthorization (ePI) identifier: https://pmda-approvalandlicenseno//22500AMX01227000 (use: official, ) subject: MedicinalProductDefinition: identifier = http://iyaku.info/medicine#2189011F1262; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription type: Marketing Authorisation region: Japan status: Active statusDate: 2002-08-01 13:28:17+0000 holder: Organization Ohara Pharmaceutical Co., Ltd.
Generated Narrative: MedicinalProductDefinition medprodsimvastatin20 Profile: MedicinalProductDefinition (ePI) identifier: http://iyaku.info/medicine/2189011F1262 type: Medicinal Product domain: Human use status: active legalStatusOfSupply: Medicinal product subject to medical prescription name productName: Simvastatin 20 mg tablets type: Full name part part: Simvastatin type: Invented name part part part: Simvastatin type: Scientific name part part part: 20 mg type: Strength part part part: tablet type: Pharmaceutical dose form part Usages - Country Jurisdiction Language * Japan Japan Japanese (Region=Japan)
Medicinal product subject to medical prescription
Generated Narrative: PackagedProductDefinition packsimvastatin20 Profile: PackagedProductDefinition (ePI) identifier: https://pmda-packinsertno//sim4291012F1022 (use: official, ) name: Simvastatin 20 mg tablets blister type: Chemical Medininal Prodcut packageFor: MedicinalProductDefinition: identifier = http://iyaku.info/medicine#2189011F1262; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription status: Active statusDate: 2002-08-01 13:28:17+0000 containedItemQuantity: 20 mg manufacturer: Organization Ohara Pharmaceutical Co., Ltd. Packagings - Identifier Type Quantity Material * https://spor.ema.europa.eu/pmswi/placeholder Blister 30 PolyVinyl Chloride
Generated Narrative: AdministrableProductDefinition adminprodsimvastatin20 Profile: AdministrableProductDefinition (ePI) identifier: https://www.who-umc.org/phpid/9721571303255BF02181E8EC5AD60DF9 status: Active formOf: MedicinalProductDefinition: identifier = http://iyaku.info/medicine#2189011F1262; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription administrableDoseForm: Tablet unitOfPresentation: 15054000 producedFrom: ManufacturedItemDefinition: identifier = https://pmda-sccj#sim874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 RouteOfAdministrations - Code * 20053000
Generated Narrative: ManufacturedItemDefinition manitemsimvastatin20 Profile: ManufacturedItemDefinition (ePI) identifier: https://pmda-sccj/sim874291 (use: official, ) status: Active manufacturedDoseForm: Tablet unitOfPresentation: 15054000 manufacturer: Organization Ohara Pharmaceutical Co., Ltd.
Generated Narrative: Ingredient ingredientsimvastatin20 Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//AGG2FN16EV (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Active Manufacturers - Manufacturer * Organization Ohara Pharmaceutical Co., Ltd. substance Codes - Concept * trastazumab Strengths - Presentation[x] Basis * 20 mg active ingredient - basis of strength
Generated Narrative: SubstanceDefinition subsimvastatin20 Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//AGG2FN16EV (use: official, ) version: 39 status: Validated (UNII) description: White to pale yellow manufacturer: Organization Ohara Pharmaceutical Co., Ltd. Structures - MolecularFormula * C25H38O5 Names - Name Type * simvastatin Chemical Name