Generated Narrative: MedicinalProductDefinition Entocort-Solvent-and-Tablet Profile: IDMP MedicinalProductDefinition CH - SMC Authorized Dose Form: Tablet and solvent for rectal suspension CH - EPL Full Limitation Text: Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin. identifier: Medical Product Identifier/CH-7601001346451-5204201 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 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: Zugelassener Arzneimittelname Usages - Country Language * Switzerland German (Switzerland)
Tablet and solvent for rectal suspension
Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.
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: CH IDMP 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: CH IDMP 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: IDMP RegulatedAuthorization identifier: Marketing Authorisation Number/5204201 subject: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-7601001346451-5204201; 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 type: Marketing Authorisation region: Switzerland status: valid statusDate: 1993-06-18 holder: Organization Tillotts Pharma AG regulator: Organization SMC Generated Narrative: Organization #holder-Tillotts-Pharma-AG Profile: CH EPL Organization identifier: LOC Identifier/100005174, GLN Identifier/7601001346451 name: Tillotts Pharma AG Generated Narrative: Organization #regulator-SMC Profile: CH EPL Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: SMC
Generated Narrative: PackagedProductDefinition PMP-Entocort-Solvent-and-Tablet Profile: IDMP PackagedProductDefinition identifier: Clinical Product Identifier/CH-7601001346451-5204201-011 packageFor: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-7601001346451-5204201; 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 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: IDMP RegulatedAuthorization identifier: Marketing Authorisation Number/52042011 subject: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-7601001346451-5204201; 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 type: Marketing Authorisation region: Switzerland status: valid statusDate: 1993-06-18 holder: Organization Tillotts Pharma AG regulator: Organization SMC Generated Narrative: Organization #holder-Tillotts-Pharma-AG Profile: CH EPL Organization identifier: LOC Identifier/100005174, GLN Identifier/7601001346451 name: Tillotts Pharma AG Generated Narrative: Organization #regulator-SMC Profile: CH EPL Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: SMC
Generated Narrative: RegulatedAuthorization FOPH-17973 CH - EPL Reimbursement SL FOPHDossierNumber: FOPH Dossier Number/17973 status: Reimbursed statusDate: 2004-02-01 listingStatus: Listed listingPeriod: 2004-02-01 --> (ongoing) firstListingDate: 2004-02-01 costShare: 10 gamme: Rectal Vaginal CH - EPL Product Price value: CHF40.89 (CHF) type: Ex-factory price changeType: Price mutation after triennal review of pharmaceuticals changeDate: 2023-12-01 CH - EPL Product Price value: CHF63.40 (CHF) type: Retail price changeType: VAT-change changeDate: 2024-01-01 subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-7601001346451-5204201-011; 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: CH EPL Organization identifier: 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: CH IDMP ManufacturedItemDefinition status: Active manufacturedDoseForm: Tablet for rectal suspension unitOfPresentation: Tablet
Generated Narrative: ManufacturedItemDefinition MI-Solvent Profile: CH IDMP ManufacturedItemDefinition status: Active manufacturedDoseForm: Solvent for... unitOfPresentation: Bottle
Generated Narrative: AdministrableProductDefinition PhP-Budesonidum-Suspension Profile: CH IDMP AdministrableProductDefinition status: Active formOf: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-7601001346451-5204201; 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 administrableDoseForm: Rectal suspension unitOfPresentation: Bottle RouteOfAdministrations - Code * Rectal use
Generated Narrative: ClinicalUseDefinition IND-10009900 Profile: CH IDMP ClinicalUseDefinition Indication type: Indication subject: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-7601001346451-5204201; 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 indication DiseaseSymptomProcedures - Concept * Colitis ulcerative IntendedEffects - Concept * therapeutic
Generated Narrative: Ingredient Budesonidum2.3 Profile: IDMP 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: IDMP 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')