MA-6743101
type: RegulatedAuthorization
node role: treeRoot
id:
  v: MA-6743101
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-6743101 Profile: IDMP RegulatedAuthorization identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/6743101 subject: MedicinalProductDefinition: extension = Capsule, hard,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.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001403062-6743101; domain = Human; 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 type: Marketing Authorisation region: Switzerland status: valid statusDate: 2020-05-28 holder: Organization IDEOGEN AG regulator: Organization SMC Generated Narrative: Organization #holder-Ideogen-AG Profile: CH EPL Organization identifier: LOC Identifier/100012910, GLN Identifier/7601001403062 name: IDEOGEN AG Generated Narrative: Organization #regulator-SMC Profile: CH EPL Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: SMC
contained: Organization
  id:
    v: holder-Ideogen-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: 100012910
  identifier:
    system:
      v: urn:oid:2.51.1.3
    value:
      v: 7601001403062
  name:
    v: IDEOGEN 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: 6743101
subject:
  link: http://fhir.ch/ig/ch-epl/MedicinalProductDefinition/Triogen-250mg-Capsule
  reference:
    v: MedicinalProductDefinition/Triogen-250mg-Capsule
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: 2020-05-28
holder:
  reference:
    v: #holder-Ideogen-AG
regulator:
  reference:
    v: #regulator-SMC