MA-5204201
type: RegulatedAuthorization
node role: treeRoot
id:
  v: MA-5204201
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div: Generated Narrative: RegulatedAuthorization MA-5204201 Profile: IDMP RegulatedAuthorization identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/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://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; domain = Human; 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 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
contained: Organization
  id:
    v: holder-Tillotts-Pharma-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
      link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
    value:
      v: 100005174
  identifier:
    system:
      v: urn:oid: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-epl-organization
      link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
    value:
      v: 100010911
  identifier:
    system:
      v: urn:oid:2.51.1.3
    value:
      v: 7601001398511
  name:
    v: SMC
identifier:
  system:
    v: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber
  value:
    v: 5204201
subject:
  link: http://fhir.ch/ig/ch-epl/MedicinalProductDefinition/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
    code:
      v: 756000002001
    display:
      v: Marketing Authorisation
region:
  coding:
    system:
      v: urn:iso:std:iso:3166
    code:
      v: CH
    display:
      v: Switzerland
status:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status
    code:
      v: 756005023007
    display:
      v: valid
status date:
  v: 1993-06-18
holder:
  reference:
    v: #holder-Tillotts-Pharma-AG
regulator:
  reference:
    v: #regulator-SMC