Generated Narrative: MedicinalProductDefinition Triogen-250mg-Capsule Profile: MedicinalProductDefinition CH SMC - Authorized Dose Form: Capsule, hard identifier: Medical Product Identifier/CH-01100828-0674310010000 indication: Zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen. legalStatusOfSupply: Medicinal product subject to medical or veterinary prescription (B) additionalMonitoringIndicator: No Warning pediatricUseIndicator: Authorised for the treatment in children classification: trientine, 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-qrs-123; status = current; type = Fachinformation; date = 2019-12-01 00:00:00+0000 DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-qrs-321; status = current; type = Patienteninformation; date = 2019-12-01 00:00:00+0000 name productName: Triogen 250 mg, Kapseln type: FOPH Medicinal Product Name Usages - Country Language * Switzerland German (Switzerland)
Zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen.
Medicinal product subject to medical or veterinary prescription (B)
Authorised for the treatment in children
Generated Narrative: DocumentReference DocRef-FI-Triogen Language: de-CH Profile: DocumentReference identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-qrs-123 status: Current type: Fachinformation date: 2019-12-01 00:00:00+0000 content Attachments - Url * https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=67431&supportMultipleResults=1
123456789-initial submission-Example-qrs-123
Generated Narrative: DocumentReference DocRef-PI-Triogen Language: de-CH Profile: DocumentReference identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-qrs-321 status: Current type: Patienteninformation date: 2019-12-01 00:00:00+0000 content Attachments - Url * https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&lang=DE&authNr=67431&supportMultipleResults=1
123456789-initial submission-Example-qrs-321
Generated Narrative: RegulatedAuthorization MA-6743101 Profile: RegulatedAuthorization identifier: Marketing Authorisation Number/6743101 subject: MedicinalProductDefinition: extension = Capsule, hard; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100828-0674310010000; indication = Zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = trientine,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia type: Marketing Authorisation region: Switzerland status: valid statusDate: 2020-05-28 holder: Organization IDEOGEN AG regulator: Organization Swissmedic Swiss Agency for Therapeutic Products Generated Narrative: Organization #holder-Ideogen-AG Profile: Organization identifier: Swissmedic Location Identifier/01100828, LOC Identifier/100012910, GLN Identifier/7601001403062 name: IDEOGEN 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-Triogen-250mg-Capsule Profile: PackagedProductDefinition identifier: Clinical Product Identifier/CH-01100828-0674310010000-0001 packageFor: MedicinalProductDefinition: extension = Capsule, hard; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100828-0674310010000; indication = Zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = trientine,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia containedItemQuantity: 100 Capsule (Details: EDQM - Standard Terms code15012000 = 'Capsule') description: TRIOGEN Kaps 250 mg Ds 100 Stk LegalStatusOfSupplies - Code * Medicinal product subject to medical or veterinary prescription (B) packaging identifier: Global Trade Item Number/7680674310013 type: Box quantity: 1 ShelfLifeStorages - Type SpecialPrecautionsForStorage * Shelf life of the medicinal product as packaged for sale Do not store above 30°C
Shelf life of the medicinal product as packaged for sale
Generated Narrative: RegulatedAuthorization MA-67431001 Profile: RegulatedAuthorization identifier: Marketing Authorisation Number/67431001 subject: MedicinalProductDefinition: extension = Capsule, hard; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100828-0674310010000; indication = Zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = trientine,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia type: Marketing Authorisation region: Switzerland status: valid statusDate: 2020-05-28 holder: Organization IDEOGEN AG regulator: Organization Swissmedic Swiss Agency for Therapeutic Products Generated Narrative: Organization #holder-Ideogen-AG Profile: Organization identifier: Swissmedic Location Identifier/01100828, LOC Identifier/100012910, GLN Identifier/7601001403062 name: IDEOGEN 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-21070 CH EPL - Reimbursement SL url FOPHDossierNumber value: FOPH Dossier Number/21070 url status value: Reimbursed url statusDate value: 2020-09-01 url listingStatus value: Listed url listingPeriod value: 2020-09-01 --> (ongoing) url firstListingDate value: 2020-09-01 url costShare value: 10 url gamme value: Oral value: CHF4,117.12 (CHF) type: Ex-factory price changeType: Price mutation at first listing changeDate: 2020-09-01 url CH EPL - Product Price value: CHF4,470.40 (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-01100828-0674310010000-0001; containedItemQuantity = 100 Capsule; description = TRIOGEN Kaps 250 mg Ds 100 Stk type: Reimbursement SL Indications - Extension Reference * ClinicalUseDefinition: type = indication holder: Organization IDEOGEN AG Generated Narrative: Organization #holder-Ideogen-AG Profile: Organization identifier: Swissmedic Location Identifier/01100828, LOC Identifier/100012910, GLN Identifier/7601001403062 name: IDEOGEN AG
Price mutation after triennal review of pharmaceuticals
Generated Narrative: ManufacturedItemDefinition MI-Trientinum-250mg-Capsule Profile: ManufacturedItemDefinition status: Active manufacturedDoseForm: Capsule, hard unitOfPresentation: Capsule
Generated Narrative: AdministrableProductDefinition PhP-Trientinum-250mg-Capsule Profile: AdministrableProductDefinition status: Active formOf: MedicinalProductDefinition: extension = Capsule, hard; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100828-0674310010000; indication = Zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = trientine,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia administrableDoseForm: Capsule, hard unitOfPresentation: Capsule RouteOfAdministrations - Code * Oral use
Generated Narrative: Ingredient Trientinum250 Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Capsule, hard; unitOfPresentation = Capsule ManufacturedItemDefinition: status = active; manufacturedDoseForm = Capsule, hard; unitOfPresentation = Capsule role: Active substance Codes - Concept * Trientine Strengths - Presentation[x] * 250 mg (Details: UCUM codemg = 'mg')/1 Capsule (Details: EDQM - Standard Terms code15012000 = 'Capsule')
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-TRIOGEN type: Indication indication DiseaseSymptomProcedures - Concept * TRIOGEN wird vergütet zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, 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
TRIOGEN wird vergütet zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, 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.