Generated Narrative: MedicinalProductDefinition Cuprior-150mg-Filmcoatedtablet Profile: MedicinalProductDefinition CH SMC - Authorized Dose Form: Film-coated tablet identifier: Medical Product Identifier/CH-01100726-0677190010000 indication: Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie. legalStatusOfSupply: Medicinal product subject to medical or veterinary prescription (B) additionalMonitoringIndicator: No Warning pediatricUseIndicator: Authorised for the treatment in children classification: gilteritinib, NA KAS art. 12 para. 5 TPLO, Synthetic, Originator product, 07. STOFFWECHSEL, 07.99. Varia attachedDocument: DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-abc-123; status = current; type = Information for healthcare professionals; date = 2020-09-01 00:00:00+0000 DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-abc-321; status = current; type = Patient Information; date = 2020-09-01 00:00:00+0000 name productName: Cuprior 150 mg, Filmtabletten type: FOPH Medicinal Product Name Usages - Country Language * Switzerland German (Switzerland)
Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.
Medicinal product subject to medical or veterinary prescription (B)
Authorised for the treatment in children
Generated Narrative: DocumentReference DocRef-FI-Cuprior Language: de-CH Profile: DocumentReference identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-abc-123 status: Current type: Information for healthcare professionals date: 2020-09-01 00:00:00+0000 content Attachments - Url * https://swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=67719&supportMultipleResults=1
123456789-initial submission-Example-abc-123
Information for healthcare professionals
Generated Narrative: DocumentReference DocRef-PI-Cuprior Language: de-CH Profile: DocumentReference identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-abc-321 status: Current type: Patient Information date: 2020-09-01 00:00:00+0000 content Attachments - Url * https://swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67719&supportMultipleResults=1
123456789-initial submission-Example-abc-321
Generated Narrative: RegulatedAuthorization MA-6771901 Profile: RegulatedAuthorization identifier: Marketing Authorisation Number/6771901 subject: MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100726-0677190010000; indication = Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia type: Marketing Authorisation region: Switzerland status: valid statusDate: 2021-01-21 holder: Organization Curatis AG regulator: Organization Swissmedic Swiss Agency for Therapeutic Products Generated Narrative: Organization #holder-Curatis-AG Profile: Organization identifier: Swissmedic Location Identifier/01100726, LOC Identifier/100082791, GLN Identifier/7640109110007 name: Curatis AG Generated Narrative: Organization #regulator-SMC Profile: Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: Swissmedic Swiss Agency for Therapeutic Products
Swissmedic Swiss Agency for Therapeutic Products
Generated Narrative: PackagedProductDefinition PMP-Cuprior-150mg-Filmcoatedtablet Profile: PackagedProductDefinition identifier: Clinical Product Identifier/CH-01100726-0677190010000-0001 packageFor: MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100726-0677190010000; indication = Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia containedItemQuantity: 72 Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet') description: CUPRIOR Filmtabl 150 mg 72 Stk LegalStatusOfSupplies - Code * Medicinal product subject to medical or veterinary prescription (B) packaging identifier: Global Trade Item Number/7680677190018 type: Box quantity: 1 ShelfLifeStorages - Type Period[x] SpecialPrecautionsForStorage * Shelf life of the medicinal product as packaged for sale No display for Duration (value: 36; unit: month; system: http://unitsofmeasure.org; code: mo) Do not store above 30°C Characteristics - Type Value[x] * Package Size Type Modal pack
Shelf life of the medicinal product as packaged for sale
Generated Narrative: RegulatedAuthorization MA-67719001 Profile: RegulatedAuthorization identifier: Marketing Authorisation Number/67719001 subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-01100726-0677190010000-0001; containedItemQuantity = 72 Tablet; description = CUPRIOR Filmtabl 150 mg 72 Stk type: Marketing Authorisation region: Switzerland status: valid statusDate: 2021-01-21 holder: Organization Curatis AG regulator: Organization Swissmedic Swiss Agency for Therapeutic Products Generated Narrative: Organization #holder-Curatis-AG Profile: Organization identifier: Swissmedic Location Identifier/01100726, LOC Identifier/100082791, GLN Identifier/7640109110007 name: Curatis AG Generated Narrative: Organization #regulator-SMC Profile: Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: Swissmedic Swiss Agency for Therapeutic Products
Generated Narrative: RegulatedAuthorization FOPH-21208 Profile: RegulatedAuthorization CH EPL - Reimbursement SL url FOPHDossierNumber value: FOPH Dossier Number/21208 url status value: Reimbursed url statusDate value: 2021-08-01 url listingStatus value: Listed url listingPeriod value: 2021-08-01 --> (ongoing) url firstListingDate value: 2021-08-01 url costShare value: 10 url gamme value: Oral value: CHF3,022.10 (CHF) type: Ex-factory price changeType: Price mutation after triennal review of pharmaceuticals changeDate: 2024-01-01 url CH EPL - Product Price value: CHF3,347.10 (CHF) type: Retail price changeType: VAT-change changeDate: 2024-01-01 url CH EPL - Product Price subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-01100726-0677190010000-0001; containedItemQuantity = 72 Tablet; description = CUPRIOR Filmtabl 150 mg 72 Stk type: Reimbursement SL Indications - Extension Reference * ClinicalUseDefinition: type = indication holder: Organization Curatis AG Generated Narrative: Organization #holder-Curatis-AG Profile: Organization identifier: Swissmedic Location Identifier/01100726, LOC Identifier/100082791, GLN Identifier/7640109110007 name: Curatis AG
Price mutation after triennal review of pharmaceuticals
Generated Narrative: ManufacturedItemDefinition MI-Trientinum-150mg-Filmcoatedtablet Profile: ManufacturedItemDefinition status: Active manufacturedDoseForm: Film-coated tablet unitOfPresentation: Tablet
Generated Narrative: AdministrableProductDefinition PhP-Trientinum-150mg-Filmcoatedtablet Profile: AdministrableProductDefinition status: Active formOf: MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100726-0677190010000; indication = Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia administrableDoseForm: Film-coated tablet unitOfPresentation: Tablet RouteOfAdministrations - Code * Oral use
Generated Narrative: Ingredient Trientinum150 Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet role: Active substance Codes - Concept * Trientine Strengths - Presentation[x] * 150 mg (Details: UCUM codemg = 'mg')/1 Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet')
Generated Narrative: ClinicalUseDefinition IND-10061091 Profile: ClinicalUseDefinition Indication type: Indication subject: MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100726-0677190010000; indication = Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia indication DiseaseSymptomProcedures - Concept * Wilson's disease IntendedEffects - Concept * therapeutic
Generated Narrative: ClinicalUseDefinition LIM-79886009-CUPRIOR type: Indication indication DiseaseSymptomProcedures - Concept * CUPRIOR wird vergütet zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter, die eine Behandlung mit D-Penicillamin nicht vertragen. Die Behandlung muss von Gastroenterologen oder Hepatologen mit Erfahrung bei der Behandlung von Patienten mit Morbus Wilson initiiert und überwacht werden. IntendedEffects - Concept * therapeutic
CUPRIOR wird vergütet zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter, die eine Behandlung mit D-Penicillamin nicht vertragen. Die Behandlung muss von Gastroenterologen oder Hepatologen mit Erfahrung bei der Behandlung von Patienten mit Morbus Wilson initiiert und überwacht werden.