Generated Narrative: Composition composition-en-25bbfa948f4a0b224f9baa1fe481efa8 Language: en Profile: Composition (ePI) identifier: https://spor.ema.europa.eu/rmswi//50d2abb4441275478b3d10432498aec6 status: Final type: Package Leaflet category: Raw date: 2022-02-16 13:28:17+0000 author: Organization Pfizer Europe MA EEIG title: TEST PURPOSES ONLY - Enbrel 25 mg powder for solution for injection Attesters - Mode Time * Official 2022-02-16 13:28:17+0000
TEST PURPOSES ONLY - Enbrel 25 mg powder for solution for injection
unavailable
Package leaflet: Information for the user
1. What Enbrel 25 mg powder for solution for injection is and what it is used for
2. What you need to know before you take Enbrel 25 mg powder for solution for injection
3. How to take Enbrel 25 mg powder for solution for injection
5. How to store Enbrel 25 mg powder for solution for injection
6. Contents of the pack and other information
Generated Narrative: Ingredient ingredient-for-enbrel-sucrose Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/C151H8M554 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/99/126/003 (use: official, ); status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial MedicinalProductDefinition: identifier = http://fakesys.com/ids#zz; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#id; status = active; administrableDoseForm = Powder for solution for injection; unitOfPresentation = Vial role: Excipient substance Codes - Concept * SUCROSE
Generated Narrative: Ingredient ingredient-for-enbrel-mannitol Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/3OWL53L36A (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/99/126/003 (use: official, ); status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial MedicinalProductDefinition: identifier = http://fakesys.com/ids#zz; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#id; status = active; administrableDoseForm = Powder for solution for injection; unitOfPresentation = Vial role: Excipient substance Codes - Concept * MANNITOL
Generated Narrative: Ingredient ingredient-for-enbrel-etanercept Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/OP401G7OJC (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/99/126/003 (use: official, ); status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial MedicinalProductDefinition: identifier = http://fakesys.com/ids#zz; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#id; status = active; administrableDoseForm = Powder for solution for injection; unitOfPresentation = Vial role: Active substance Codes - Concept * Etanercept Strengths - Presentation[x] Basis * 25 mg (Details: UCUM codemg = 'mg') active ingredient - basis of strength
Generated Narrative: Ingredient ingredient-for-enbrel-tromethamine Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/023C2WHX2V (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/99/126/003 (use: official, ); status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial MedicinalProductDefinition: identifier = http://fakesys.com/ids#zz; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#id; status = active; administrableDoseForm = Powder for solution for injection; unitOfPresentation = Vial role: Excipient substance Codes - Concept * TROMETHAMINE
Generated Narrative: SubstanceDefinition substance-etanercept Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//OP401G7OJC (use: official, ) status: Active manufacturer: Organization Pfizer Europe MA EEIG
Generated Narrative: AdministrableProductDefinition ap-7f657b63823319aa7da7d2c5939e39e5 Profile: AdministrableProductDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/id status: Active formOf: MedicinalProductDefinition: identifier = http://fakesys.com/ids#zz; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription administrableDoseForm: Powder for solution for injection unitOfPresentation: Vial producedFrom: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/99/126/003 (use: official, ); status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial routeOfAdministration code: Subcutaneous use TargetSpecies - Code * Human
Generated Narrative: RegulatedAuthorization authorization7f657b63823319aa7da7d2c5939e39e50 Profile: RegulatedAuthorization (ePI) identifier: https://spor.ema.europa.eu/pmswi/EU/1/99/126/003 (use: official, ) subject: MedicinalProductDefinition: identifier = http://fakesys.com/ids#zz; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription type: Marketing Authorisation status: Active statusDate: 2009-11-26 13:28:17+0000 holder: Organization Pfizer Europe MA EEIG
Generated Narrative: Organization mah-9800de324c3962f6f767647a95e0c17e Profile: Organization (ePI) identifier: https://spor.ema.europa.eu/omswi/ORG-100011459 (use: official, ) active: true type: Marketing authorisation holder name: Pfizer Europe MA EEIG Contacts - Address * Boulevard de la Plaine 17,1050 Bruxelles Bruxelles BE(work)
Boulevard de la Plaine 17,1050 Bruxelles Bruxelles BE
Boulevard de la Plaine 17,1050 Bruxelles
Generated Narrative: PackagedProductDefinition ppd-51ddf55f89e2cd74ee3392c14c809976 Profile: PackagedProductDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/EU/1/99/126/003 (use: official, ) name: Enbrel 25 mg powder for solution for injection 28 type: Chemical Medicinal Product packageFor: MedicinalProductDefinition: identifier = http://fakesys.com/ids#zz; 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: 25 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#EU/1/99/126/003 (use: official, ); status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial
Enbrel 25 mg powder for solution for injection 28
Generated Narrative: MedicinalProductDefinition mp25bbfa948f4a0b224f9baa1fe481efa8 Profile: MedicinalProductDefinition (ePI) identifier: http://fakesys.com/ids/zz type: Medicinal Product domain: Human use status: active legalStatusOfSupply: Medicinal product subject to medical prescription name productName: Enbrel 25 mg powder for solution for injection type: Full name part part: Enbrel type: Invented name part part part: Etanercept type: Scientific name part part part: 25 mg type: Strength part part part: powder for solution for injection type: Pharmaceutical dose form part Usages - Country Jurisdiction Language * Norway Norway English
Medicinal product subject to medical prescription
Enbrel 25 mg powder for solution for injection
Generated Narrative: ManufacturedItemDefinition mid-7f657b63823319aa7da7d2c5939e39e5 Profile: ManufacturedItemDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/EU/1/99/126/003 (use: official, ) status: Active manufacturedDoseForm: Powder for solution for injection unitOfPresentation: Vial