MA-54704089
type: RegulatedAuthorization
node role: treeRoot
id:
  v: MA-54704089
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-54704089 Profile: IDMP RegulatedAuthorization identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/54704089 subject: MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = Human; indication = Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen. Osteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = norethisterone and estrogen,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product type: Marketing Authorisation region: Switzerland status: valid statusDate: 1999-08-17 holder: Organization Sandoz Pharmaceuticals AG regulator: Organization SMC Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG Profile: CH EPL Organization identifier: LOC Identifier/100054743, GLN Identifier/7601001029439 name: Sandoz Pharmaceuticals AG Generated Narrative: Organization #regulator-SMC Profile: CH EPL Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: SMC
contained: Organization
  id:
    v: holder-Sandoz-Pharmaceuticals-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: 100054743
  identifier:
    system:
      v: urn:oid:2.51.1.3
    value:
      v: 7601001029439
  name:
    v: Sandoz Pharmaceuticals 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: 54704089
subject:
  link: http://fhir.ch/ig/ch-epl/MedicinalProductDefinition/Estalis-Transdermalpatch
  reference:
    v: MedicinalProductDefinition/Estalis-Transdermalpatch
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: 1999-08-17
holder:
  reference:
    v: #holder-Sandoz-Pharmaceuticals-AG
regulator:
  reference:
    v: #regulator-SMC