Generated Narrative: Composition composition-en-245a2b4a9e3ee4304e5e6cf2b1a252b4 Language: en Profile: Composition (ePI) identifier: https://spor.ema.europa.eu/rmswi//33baa39274e4f9e04535de6e365fb5af status: Final type: Package Leaflet category: Raw date: 2022-02-16 13:28:17+0000 author: Organization Sandoz A/S title: TEST PURPOSES ONLY - Lipcut Simvastatin 5 mg Tablet Attesters - Mode Time * Official 2022-02-16 13:28:17+0000
TEST PURPOSES ONLY - Lipcut Simvastatin 5 mg Tablet
unavailable
Package leaflet: Information for the user
1. What Lipcut Simvastatin 5 mg Tablet is and what it is used for
2. What you need to know before you take Lipcut Simvastatin 5 mg Tablet
3. How to take Lipcut Simvastatin 5 mg Tablet
5. How to store Lipcut Simvastatin 5 mg Tablet
6. Contents of the pack and other information
Generated Narrative: Ingredient ingredient-for-simvastatine-titaniumdioxide Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/15FIX9V2JP (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#fin-x (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://www.who-umc.org/phpid#F92168108C432D63DACDD70444176BB3; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#fin-x; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * TITANIUM DIOXIDE
Generated Narrative: Ingredient ingredient-for-simvastatine-hypromelloseunspecified Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/3NXW29V3WO (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#fin-x (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://www.who-umc.org/phpid#F92168108C432D63DACDD70444176BB3; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#fin-x; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * HYPROMELLOSE, UNSPECIFIED
Generated Narrative: Ingredient ingredient-for-simvastatine-simvastatin Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/AGG2FN16EV (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#fin-x (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://www.who-umc.org/phpid#F92168108C432D63DACDD70444176BB3; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#fin-x; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Active substance Codes - Concept * SIMVASTATIN Strengths - Presentation[x] Basis * 5 mg (Details: UCUM codemg = 'mg') active ingredient - basis of strength
Generated Narrative: SubstanceDefinition substance-simvastatin Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//AGG2FN16EV (use: official, ) status: Active manufacturer: Organization Sandoz A/S
Generated Narrative: AdministrableProductDefinition ap-660952efa1b907b97e182807063ac261 Profile: AdministrableProductDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/fin-x status: Active formOf: MedicinalProductDefinition: identifier = https://www.who-umc.org/phpid#F92168108C432D63DACDD70444176BB3; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription administrableDoseForm: Tablet unitOfPresentation: Tablet producedFrom: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#fin-x (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet routeOfAdministration code: Oral use TargetSpecies - Code * Human
Generated Narrative: RegulatedAuthorization authorization660952efa1b907b97e182807063ac2610 Profile: RegulatedAuthorization (ePI) identifier: https://spor.ema.europa.eu/pmswi/fin-x (use: official, ) subject: MedicinalProductDefinition: identifier = https://www.who-umc.org/phpid#F92168108C432D63DACDD70444176BB3; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription type: Marketing Authorisation status: Active statusDate: 2015-02-07 13:28:17+0000 holder: Organization Sandoz A/S
Generated Narrative: Organization mah-1f2bde1de64d7b561417b3a3d4313827 Profile: Organization (ePI) identifier: https://spor.ema.europa.eu/omswi/ORG-100000848 (use: official, ) active: true type: Marketing authorisation holder name: Sandoz A/S Contacts - Address * Edvard Thomsens Vej 14 Copenhagen S DK(work)
Generated Narrative: PackagedProductDefinition ppd-eac96261823092966bc3d7659feb5d7a Profile: PackagedProductDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/fin-x (use: official, ) name: Lipcut Simvastatin 5 mg Tablet 28 type: Chemical Medicinal Product packageFor: MedicinalProductDefinition: identifier = https://www.who-umc.org/phpid#F92168108C432D63DACDD70444176BB3; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription status: Active statusDate: 2015-02-07 13:28:17+0000 containedItemQuantity: 5 mg (Details: UCUM codemg = 'mg') packaging type: Box quantity: 1 material: Cardboard packaging identifier: https://spor.ema.europa.eu/pmswi/123456 type: Blister quantity: 28 material: PolyVinyl Chloride containedItem Items - Reference * ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#fin-x (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet
Generated Narrative: MedicinalProductDefinition mp245a2b4a9e3ee4304e5e6cf2b1a252b4 Profile: MedicinalProductDefinition (ePI) identifier: https://www.who-umc.org/phpid/F92168108C432D63DACDD70444176BB3 type: Medicinal Product domain: Human use status: active legalStatusOfSupply: Medicinal product subject to medical prescription name productName: Lipcut Simvastatin 5 mg Tablet type: Full name part part: Lipcut type: Invented name part part part: Simvastatin type: Scientific name part part part: 5 mg type: Strength part part part: tablet type: Pharmaceutical dose form part Usages - Country Jurisdiction Language * Finland Finland English
Medicinal product subject to medical prescription
Generated Narrative: ManufacturedItemDefinition mid-660952efa1b907b97e182807063ac261 Profile: ManufacturedItemDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/fin-x (use: official, ) status: Active manufacturedDoseForm: Tablet unitOfPresentation: Tablet