Generated Narrative: MedicinalProductDefinition Entocort-Solvent-and-Tablet Profile: MedicinalProductDefinition CH SMC - Authorized Dose Form: Tablet and solvent for rectal suspension identifier: Medical Product Identifier/CH-01002393-0520420010000 combinedPharmaceuticalDoseForm: Tablet and solvent for rectal suspension indication: Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum. legalStatusOfSupply: Medicinal product subject to medical or veterinary prescription (B) additionalMonitoringIndicator: No Warning pediatricUseIndicator: Authorised for the treatment in children classification: budesonide, NA KAS art. 12 para. 5 TPLO, Synthetic, Originator product, 04. GASTROENTEROLOGICA, 04.99. Varia attachedDocument: DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-efg-123; status = current; type = Fachinformation; date = 2022-04-01 00:00:00+0000 DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-efg-321; status = current; type = Patienteninformation; date = 2022-04-01 00:00:00+0000 name productName: ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk type: FOPH Medicinal Product Name Usages - Country Language * Switzerland German (Switzerland)
Tablet and solvent for rectal suspension
Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.
Medicinal product subject to medical or veterinary prescription (B)
Authorised for the treatment in children
ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk
Generated Narrative: DocumentReference DocRef-FI-Entocort Language: de-CH Profile: DocumentReference identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-efg-123 status: Current type: Fachinformation date: 2022-04-01 00:00:00+0000 content Attachments - Url * https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=52042&supportMultipleResults=1
123456789-initial submission-Example-efg-123
Generated Narrative: DocumentReference DocRef-PI-Entocort Language: de-CH Profile: DocumentReference identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-efg-321 status: Current type: Patienteninformation date: 2022-04-01 00:00:00+0000 content Attachments - Url * https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&lang=DE&authNr=52042&supportMultipleResults=1
123456789-initial submission-Example-efg-321
Generated Narrative: RegulatedAuthorization MA-5204201 Profile: RegulatedAuthorization identifier: Marketing Authorisation Number/5204201 subject: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01002393-0520420010000; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = budesonide,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,04. GASTROENTEROLOGICA,04.99. Varia type: Marketing Authorisation region: Switzerland status: valid statusDate: 1993-06-18 holder: Organization Tillotts Pharma AG regulator: Organization Swissmedic Swiss Agency for Therapeutic Products Generated Narrative: Organization #holder-Tillotts-Pharma-AG Profile: Organization identifier: Swissmedic Location Identifier/01002393, LOC Identifier/100005174, GLN Identifier/7601001346451 name: Tillotts Pharma 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-Entocort-Solvent-and-Tablet Profile: PackagedProductDefinition identifier: Clinical Product Identifier/CH-01002393-0520420010000-0011 packageFor: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01002393-0520420010000; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = budesonide,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,04. GASTROENTEROLOGICA,04.99. Varia containedItemQuantity: 7 Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet'), 7 Bottle (Details: EDQM - Standard Terms code30008000 = 'Bottle') description: ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk LegalStatusOfSupplies - Code * Medicinal product subject to medical or veterinary prescription (B) packaging identifier: Global Trade Item Number/7680520420118 type: Box quantity: 1 ShelfLifeStorages - Type Period[x] SpecialPrecautionsForStorage * Shelf life of the medicinal product as packaged for sale No display for Duration (value: 60; unit: month; system: http://unitsofmeasure.org; code: mo) Do not store above 30°C
Shelf life of the medicinal product as packaged for sale
Generated Narrative: RegulatedAuthorization MA-52042011 Profile: RegulatedAuthorization identifier: Marketing Authorisation Number/52042011 subject: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01002393-0520420010000; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = budesonide,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,04. GASTROENTEROLOGICA,04.99. Varia type: Marketing Authorisation region: Switzerland status: valid statusDate: 1993-06-18 holder: Organization Tillotts Pharma AG regulator: Organization Swissmedic Swiss Agency for Therapeutic Products Generated Narrative: Organization #holder-Tillotts-Pharma-AG Profile: Organization identifier: Swissmedic Location Identifier/01002393, LOC Identifier/100005174, GLN Identifier/7601001346451 name: Tillotts Pharma 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-17973 CH EPL - Reimbursement SL url FOPHDossierNumber value: FOPH Dossier Number/17973 url status value: Reimbursed url statusDate value: 2004-02-01 url listingStatus value: Listed url listingPeriod value: 2004-02-01 --> (ongoing) url firstListingDate value: 2004-02-01 url costShare value: 10 url gamme value: Rectal Vaginal value: CHF40.89 (CHF) type: Ex-factory price changeType: Price mutation after triennal review of pharmaceuticals changeDate: 2023-12-01 url CH EPL - Product Price value: CHF63.40 (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-01002393-0520420010000-0011; containedItemQuantity = 7 Tablet,7 Bottle; description = ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk type: Reimbursement SL Indications - Extension Reference * ClinicalUseDefinition: type = indication holder: Organization Tillotts Pharma AG Generated Narrative: Organization #holder-Tillotts-Pharma-AG Profile: Organization identifier: Swissmedic Location Identifier/01002393, LOC Identifier/100005174, GLN Identifier/7601001346451 name: Tillotts Pharma AG
Price mutation after triennal review of pharmaceuticals
Generated Narrative: ManufacturedItemDefinition MI-Budesonidum-2.3mg-Tablet Profile: ManufacturedItemDefinition status: Active manufacturedDoseForm: Tablet for rectal suspension unitOfPresentation: Tablet
Generated Narrative: ManufacturedItemDefinition MI-Solvent Profile: ManufacturedItemDefinition status: Active manufacturedDoseForm: Solvent for... unitOfPresentation: Bottle
Generated Narrative: AdministrableProductDefinition PhP-Budesonidum-Suspension Profile: AdministrableProductDefinition status: Active formOf: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01002393-0520420010000; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = budesonide,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,04. GASTROENTEROLOGICA,04.99. Varia administrableDoseForm: Rectal suspension unitOfPresentation: Bottle RouteOfAdministrations - Code * Rectal use
Generated Narrative: ClinicalUseDefinition IND-10009900 Profile: ClinicalUseDefinition Indication type: Indication subject: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01002393-0520420010000; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = budesonide,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,04. GASTROENTEROLOGICA,04.99. Varia indication DiseaseSymptomProcedures - Concept * Colitis ulcerative IntendedEffects - Concept * therapeutic
Generated Narrative: Ingredient Budesonidum2.3 Profile: Ingredient status: Active for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet for rectal suspension; unitOfPresentation = Tablet role: Active substance Codes - Concept * Budesonide Strengths - Presentation[x] * 2.3 mg (Details: UCUM codemg = 'mg')/1 Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet')
Generated Narrative: Ingredient Budesonidum2.0 Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Rectal suspension; unitOfPresentation = Bottle role: Active substance Codes - Concept * Budesonide Strengths - Concentration[x] * 2 mg (Details: UCUM codemg = 'mg')/100 ml (Details: UCUM codeml = 'ml')
Generated Narrative: ClinicalUseDefinition LIM-64766004-ENTOCORT type: Indication indication DiseaseSymptomProcedures - Concept * Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin. IntendedEffects - Concept * therapeutic
Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.