http://fhir.ch/ig/ch-epl/Bundle/6722a9ee-ae3b-4c20-bcf0-9b7cb6f062db
type: Bundle
node role: treeRoot
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle
    l: ch-idmp-bundle
type:
  v: collection
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/MedicinalProductDefinition/Entocort-Solvent-and-Tablet
    l: Entocort-Solvent-and-Tablet
  resource: Entocort-Solvent-and-Tablet
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/DocumentReference/DocRef-FI-Entocort
    l: DocRef-FI-Entocort
  resource: DocRef-FI-Entocort
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/DocumentReference/DocRef-PI-Entocort
    l: DocRef-PI-Entocort
  resource: DocRef-PI-Entocort
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/RegulatedAuthorization/MA-5204201
    l: MA-5204201
  resource: MA-5204201
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/PackagedProductDefinition/PMP-Entocort-Solvent-and-Tablet
    l: PMP-Entocort-Solvent-and-Tablet
  resource: PMP-Entocort-Solvent-and-Tablet
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/RegulatedAuthorization/MA-52042011
    l: MA-52042011
  resource: MA-52042011
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/RegulatedAuthorization/FOPH-17973
    l: FOPH-17973
  resource: FOPH-17973
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/ManufacturedItemDefinition/MI-Budesonidum-2.3mg-Tablet
    l: MI-Budesonidum-2.3mg-Tablet
  resource: MI-Budesonidum-2.3mg-Tablet
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/ManufacturedItemDefinition/MI-Solvent
    l: MI-Solvent
  resource: MI-Solvent
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/AdministrableProductDefinition/PhP-Budesonidum-Suspension
    l: PhP-Budesonidum-Suspension
  resource: PhP-Budesonidum-Suspension
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/ClinicalUseDefinition/IND-10009900
    l: IND-10009900
  resource: IND-10009900
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/Ingredient/Budesonidum2.3
    l: Budesonidum2.3
  resource: Budesonidum2.3
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/Ingredient/Budesonidum2.0
    l: Budesonidum2.0
  resource: Budesonidum2.0
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/ClinicalUseDefinition/LIM-64766004-ENTOCORT
    l: LIM-64766004-ENTOCORT
  resource: LIM-64766004-ENTOCORT

Entocort-Solvent-and-Tablet
type: MedicinalProductDefinition
id:
  v: Entocort-Solvent-and-Tablet
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition
    l: ch-idmp-medicinalproductdefinition
text:
  status:
    v: extensions
  div:
    v: 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)
extension:
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm
    l: authorizedDoseForm
  value: CodeableConcept
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 50064000
      display:
        v: Tablet and solvent for rectal suspension
identifier:
  system:
    v: http://fhir.ch/ig/ch-epl/sid/mpid
    l: mpid
  value:
    v: CH-01002393-0520420010000
combined pharmaceutical dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 50064000
    display:
      v: Tablet and solvent for rectal suspension
indication:
  v: Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.
legal status of supply:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply
      l: ch-SMC-legal-status-of-supply
    code:
      v: 756005022003
    display:
      v: Medicinal product subject to medical or veterinary prescription (B)
additional monitoring indicator:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-additional-monitoring-indicator
      l: ch-SMC-additional-monitoring-indicator
    code:
      v: 756005001003
    display:
      v: No Warning
pediatric use indicator:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-pediatric-use-indicator
      l: ch-SMC-pediatric-use-indicator
    code:
      v: 756005003001
    display:
      v: Authorised for the treatment in children
classification:
  coding:
    system:
      v: http://www.whocc.no/atc
      l: atc
    code:
      v: A07EA06
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-category
      l: ch-SMC-authorisation-category
    code:
      v: 756005021001
    display:
      v: NA KAS art. 12 para. 5 TPLO
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode
      l: ch-SMC-therapeuticproductcode
    code:
      v: 756005004001
    display:
      v: Synthetic
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type
      l: ch-epl-foph-product-type
    code:
      v: 756001003002
    display:
      v: Originator product
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus
      l: ch-epl-foph-index-therapeuticus
    code:
      v: 040000
    display:
      v: 04. GASTROENTEROLOGICA
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus
      l: ch-epl-foph-index-therapeuticus
    code:
      v: 049900
    display:
      v: 04.99. Varia
attached document:
  l: DocRef-FI-Entocort
  reference:
    v: DocumentReference/DocRef-FI-Entocort
attached document:
  l: DocRef-PI-Entocort
  reference:
    v: DocumentReference/DocRef-PI-Entocort
name:
  product name:
    v: ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk
  type:
    coding:
      system:
        v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-medicinal-product-name-type
        l: ch-medicinal-product-name-type
      code:
        v: FOPH
      display:
        v: FOPH Medicinal Product Name

DocRef-FI-Entocort
type: DocumentReference
id:
  v: DocRef-FI-Entocort
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference
    l: ch-idmp-documentreference
language:
  v: de-CH
text:
  status:
    v: generated
  div:
    v: 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
identifier:
  system:
    v: http://fhir.ch/ig/ch-epl/sid/attno
    l: attno
  value:
    v: 123456789-initial submission-Example-efg-123
status:
  v: current
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type
      l: ch-SMC-attached-document-type
    code:
      v: 756005007001
    display:
      v: Fachinformation
date:
  v: 2022-04-01T00:00:00Z
content:
  attachment:
    url:
      v: https://swissmedicinfo.ch/showTextAccepted.aspx
      l: https://swissmedicinfo.ch/showTextAccepted.aspx

DocRef-PI-Entocort
type: DocumentReference
id:
  v: DocRef-PI-Entocort
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference
    l: ch-idmp-documentreference
language:
  v: de-CH
text:
  status:
    v: generated
  div:
    v: 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
identifier:
  system:
    v: http://fhir.ch/ig/ch-epl/sid/attno
    l: attno
  value:
    v: 123456789-initial submission-Example-efg-321
status:
  v: current
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type
      l: ch-SMC-attached-document-type
    code:
      v: 756005007002
    display:
      v: Patienteninformation
date:
  v: 2022-04-01T00:00:00Z
content:
  attachment:
    url:
      v: https://swissmedicinfo.ch/showTextAccepted.aspx
      l: https://swissmedicinfo.ch/showTextAccepted.aspx

MA-5204201
type: RegulatedAuthorization
id:
  v: MA-5204201
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization
    l: ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div:
    v: 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
contained: Organization
  id:
    v: holder-Tillotts-Pharma-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://www.swissmedic.ch/fhir/identifier/locations
      l: locations
    value:
      v: 01002393
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100005174
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001346451
  name:
    v: Tillotts Pharma AG
contained: Organization
  id:
    v: regulator-SMC
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100010911
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001398511
  name:
    v: Swissmedic Swiss Agency for Therapeutic Products
identifier:
  system:
    v: http://fhir.ch/ig/ch-epl/sid/authno
    l: authno
  value:
    v: 5204201
subject:
  l: Entocort-Solvent-and-Tablet
  reference:
    v: MedicinalProductDefinition/Entocort-Solvent-and-Tablet
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
      l: ch-authorisation-type
    code:
      v: 756000002001
    display:
      v: Marketing Authorisation
region:
  coding:
    system:
      v: urn:iso:std:iso:3166
      l: 3166
    code:
      v: CH
    display:
      v: Switzerland
status:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status
      l: ch-SMC-authorisation-status
    code:
      v: 756005023007
    display:
      v: valid
status date:
  v: 1993-06-18
holder:
  l: holder-Tillotts-Pharma-AG
  reference:
    v: #holder-Tillotts-Pharma-AG
regulator:
  l: regulator-SMC
  reference:
    v: #regulator-SMC

PMP-Entocort-Solvent-and-Tablet
type: PackagedProductDefinition
id:
  v: PMP-Entocort-Solvent-and-Tablet
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition
    l: ch-idmp-packagedproductdefinition
text:
  status:
    v: generated
  div:
    v: 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
identifier:
  system:
    v: http://fhir.ch/ig/ch-epl/sid/pcid
    l: pcid
  value:
    v: CH-01002393-0520420010000-0011
package for:
  l: Entocort-Solvent-and-Tablet
  reference:
    v: MedicinalProductDefinition/Entocort-Solvent-and-Tablet
contained item quantity:
  value:
    v: 7
  unit:
    v: Tablet
  system:
    v: http://standardterms.edqm.eu
    l: standardterms.edqm.eu
  code:
    v: 15054000
contained item quantity:
  value:
    v: 7
  unit:
    v: Bottle
  system:
    v: http://standardterms.edqm.eu
    l: standardterms.edqm.eu
  code:
    v: 30008000
description:
  v: ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk
legal status of supply:
  code:
    coding:
      system:
        v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply
        l: ch-SMC-legal-status-of-supply
      code:
        v: 756005022003
      display:
        v: Medicinal product subject to medical or veterinary prescription (B)
packaging:
  identifier:
    system:
      v: urn:oid:2.51.1.1
      l: 2.51.1.1
    value:
      v: 7680520420118
  type:
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 30009000
      display:
        v: Box
  quantity:
    v: 1
  shelf life storage:
    period: Duration
      value:
        v: 60
      unit:
        v: month
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: mo

MA-52042011
type: RegulatedAuthorization
id:
  v: MA-52042011
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization
    l: ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div:
    v: 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
contained: Organization
  id:
    v: holder-Tillotts-Pharma-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://www.swissmedic.ch/fhir/identifier/locations
      l: locations
    value:
      v: 01002393
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100005174
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001346451
  name:
    v: Tillotts Pharma AG
contained: Organization
  id:
    v: regulator-SMC
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100010911
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001398511
  name:
    v: Swissmedic Swiss Agency for Therapeutic Products
identifier:
  system:
    v: http://fhir.ch/ig/ch-epl/sid/authno
    l: authno
  value:
    v: 52042011
subject:
  l: Entocort-Solvent-and-Tablet
  reference:
    v: MedicinalProductDefinition/Entocort-Solvent-and-Tablet
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
      l: ch-authorisation-type
    code:
      v: 756000002001
    display:
      v: Marketing Authorisation
region:
  coding:
    system:
      v: urn:iso:std:iso:3166
      l: 3166
    code:
      v: CH
    display:
      v: Switzerland
status:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status
      l: ch-SMC-authorisation-status
    code:
      v: 756005023007
    display:
      v: valid
status date:
  v: 1993-06-18
holder:
  l: holder-Tillotts-Pharma-AG
  reference:
    v: #holder-Tillotts-Pharma-AG
regulator:
  l: regulator-SMC
  reference:
    v: #regulator-SMC

FOPH-17973
type: RegulatedAuthorization
id:
  v: FOPH-17973
text:
  status:
    v: extensions
  div:
    v: 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
contained: Organization
  id:
    v: holder-Tillotts-Pharma-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://www.swissmedic.ch/fhir/identifier/locations
      l: locations
    value:
      v: 01002393
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100005174
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001346451
  name:
    v: Tillotts Pharma AG
extension:
  extension:
    url:
      v: FOPHDossierNumber
      l: FOPHDossierNumber
    value: Identifier
      system:
        v: urn:oid:2.16.756.1
        l: 2.16.756.1
      value:
        v: 17973
  extension:
    url:
      v: status
      l: status
    value: CodeableConcept
  extension:
    url:
      v: statusDate
      l: statusDate
    value: Date
      v: 2004-02-01
  extension:
    url:
      v: listingStatus
      l: listingStatus
    value: CodeableConcept
  extension:
    url:
      v: listingPeriod
      l: listingPeriod
    value: Period
      start:
        v: 2004-02-01
  extension:
    url:
      v: firstListingDate
      l: firstListingDate
    value: Date
      v: 2004-02-01
  extension:
    url:
      v: costShare
      l: costShare
    value: Integer
      v: 10
  extension:
    url:
      v: gamme
      l: gamme
    value: CodeableConcept
  extension:
    extension:
      url:
        v: value
        l: value
      value: Money
    extension:
      url:
        v: type
        l: type
      value: CodeableConcept
    extension:
      url:
        v: changeType
        l: changeType
      value: CodeableConcept
    extension:
      url:
        v: changeDate
        l: changeDate
      value: Date
        v: 2023-12-01
    url:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
      l: productPrice
  extension:
    extension:
      url:
        v: value
        l: value
      value: Money
    extension:
      url:
        v: type
        l: type
      value: CodeableConcept
    extension:
      url:
        v: changeType
        l: changeType
      value: CodeableConcept
    extension:
      url:
        v: changeDate
        l: changeDate
      value: Date
        v: 2024-01-01
    url:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
      l: productPrice
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL
    l: reimbursementSL
subject:
  l: PMP-Entocort-Solvent-and-Tablet
  reference:
    v: PackagedProductDefinition/PMP-Entocort-Solvent-and-Tablet
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
      l: ch-authorisation-type
    code:
      v: 756000002003
    display:
      v: Reimbursement SL
indication:
  extension:
    extension:
      url:
        v: status
        l: status
      value: CodeableConcept
    extension:
      url:
        v: statusDate
        l: statusDate
      value: Date
        v: 2007-01-01
    extension:
      url:
        v: period
        l: period
      value: Period
    extension:
      url:
        v: firstLimitationDate
        l: firstLimitationDate
      value: Date
        v: 2007-01-01
    extension:
      url:
        v: limitationIndication
        l: limitationIndication
      value: Reference
        l: LIM-64766004-ENTOCORT
    extension:
      extension:
        value: Money
      extension:
        value: CodeableConcept
      extension:
        value: CodeableConcept
      extension:
        value: Date
      url:
        v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
        l: productPrice
    extension:
      extension:
        value: Money
      extension:
        value: CodeableConcept
      extension:
        value: CodeableConcept
      extension:
        value: Date

MI-Budesonidum-2.3mg-Tablet
type: ManufacturedItemDefinition
id:
  v: MI-Budesonidum-2.3mg-Tablet
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition
    l: ch-idmp-manufactureditemdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ManufacturedItemDefinition MI-Budesonidum-2.3mg-Tablet Profile: ManufacturedItemDefinition status: Active manufacturedDoseForm: Tablet for rectal suspension unitOfPresentation: Tablet
status:
  v: active
manufactured dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 11012000
    display:
      v: Tablet for rectal suspension
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 15054000
    display:
      v: Tablet

MI-Solvent
type: ManufacturedItemDefinition
id:
  v: MI-Solvent
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition
    l: ch-idmp-manufactureditemdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ManufacturedItemDefinition MI-Solvent Profile: ManufacturedItemDefinition status: Active manufacturedDoseForm: Solvent for... unitOfPresentation: Bottle
status:
  v: active
manufactured dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 13035000
    display:
      v: Solvent for...
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 15009000
    display:
      v: Bottle

PhP-Budesonidum-Suspension
type: AdministrableProductDefinition
id:
  v: PhP-Budesonidum-Suspension
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-administrableproductdefinition
    l: ch-idmp-administrableproductdefinition
text:
  status:
    v: generated
  div:
    v: 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
status:
  v: active
form of:
  l: Entocort-Solvent-and-Tablet
  reference:
    v: MedicinalProductDefinition/Entocort-Solvent-and-Tablet
administrable dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 11006000
    display:
      v: Rectal suspension
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 15009000
    display:
      v: Bottle
route of administration:
  code:
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 20061000
      display:
        v: Rectal use

IND-10009900
type: ClinicalUseDefinition
id:
  v: IND-10009900
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication
    l: ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div:
    v: 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
type:
  v: indication
subject:
  l: Entocort-Solvent-and-Tablet
  reference:
    v: MedicinalProductDefinition/Entocort-Solvent-and-Tablet

Budesonidum2.3
type: Ingredient
id:
  v: Budesonidum2.3
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: 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')
status:
  v: active
for:
  l: MI-Budesonidum-2.3mg-Tablet
  reference:
    v: ManufacturedItemDefinition/MI-Budesonidum-2.3mg-Tablet
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005051001
    display:
      v: Active
substance:
  strength:
    presentation: Ratio

Budesonidum2.0
type: Ingredient
id:
  v: Budesonidum2.0
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: 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')
status:
  v: active
for:
  l: PhP-Budesonidum-Suspension
  reference:
    v: AdministrableProductDefinition/PhP-Budesonidum-Suspension
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005051001
    display:
      v: Active
substance:
  strength:
    concentration: Ratio

LIM-64766004-ENTOCORT
type: ClinicalUseDefinition
id:
  v: LIM-64766004-ENTOCORT
text:
  status:
    v: generated
  div:
    v: 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
type:
  v: indication
indication:
  disease symptom procedure:
    concept:
      coding: http://snomed.info/id/64766004
      text:
        v: Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.

v: urn:iso:std:iso:3166
l: 3166

v: CH

v: Switzerland

v: urn:ietf:bcp:47
l: 47

v: de-CH

v: German (Switzerland)

v: 100000073403

v: Shelf life of the medicinal product as packaged for sale

v: 756005042009

v: Do not store above 30°C

v: 756001021001

v: Reimbursed

v: 756001002001

v: Listed

v: 756002004013

v: Rectal Vaginal

v: 40.89

v: CHF

system:
  v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type
  l: ch-epl-foph-price-type
code:
  v: 756002005002
display:
  v: Ex-factory price

system:
  v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change
  l: ch-epl-foph-type-of-price-change
code:
  v: 756002006010
display:
  v: Price mutation after triennal review of pharmaceuticals

v: 63.4

v: CHF

system:
  v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type
  l: ch-epl-foph-price-type
code:
  v: 756002005001
display:
  v: Retail price

system:
  v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change
  l: ch-epl-foph-type-of-price-change
code:
  v: 756002006008
display:
  v: VAT-change

system:
  v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus
  l: ch-epl-foph-limitationstatus
code:
  v: 756002071001
display:
  v: Limitation Reimbursed

v: 2007-01-01

v: ClinicalUseDefinition/LIM-64766004-ENTOCORT

v: value
l: value

Money
value:
  v: 40.89
currency:
  v: CHF

v: type
l: type

CodeableConcept
coding:
  system:
    v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type
    l: ch-epl-foph-price-type
  code:
    v: 756002005002
  display:
    v: Ex-factory price

v: changeType
l: changeType

CodeableConcept
coding:
  system:
    v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change
    l: ch-epl-foph-type-of-price-change
  code:
    v: 756002006010
  display:
    v: Price mutation after triennal review of pharmaceuticals

v: changeDate
l: changeDate

Date
v: 2023-12-01

v: value
l: value

Money
value:
  v: 63.4
currency:
  v: CHF

v: type
l: type

CodeableConcept
coding:
  system:
    v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type
    l: ch-epl-foph-price-type
  code:
    v: 756002005001
  display:
    v: Retail price

v: changeType
l: changeType

CodeableConcept
coding:
  system:
    v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change
    l: ch-epl-foph-type-of-price-change
  code:
    v: 756002006008
  display:
    v: VAT-change

v: changeDate
l: changeDate

Date
v: 2024-01-01

l: IND-10009900
reference:
  v: ClinicalUseDefinition/IND-10009900

l: holder-Tillotts-Pharma-AG
reference:
  v: #holder-Tillotts-Pharma-AG

v: 10009900

v: Colitis ulcerative

v: 200000003194

v: therapeutic

v: Q3OKS62Q6X

v: Budesonide

v: 2.3

v: mg

v: mg

v: 1

v: Tablet

v: 15054000

v: Q3OKS62Q6X

v: Budesonide

v: 2

v: mg

v: mg

v: 100

v: ml

v: ml

v: 64766004

v: Ulcerative colitis (disorder)

v: 200000003194

v: therapeutic