CH EPL (R5)
1.0.0-ballot - ballot
CH EPL (R5)
1.0.0-ballot - ballot
This page is part of the CH EPL (R5) (v1.0.0-ballot: DSTU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions
{
"resourceType" : "RegulatedAuthorization",
"id" : "MA-54704089",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-54704089</b></p><a name=\"MA-54704089\"> </a><a name=\"hcMA-54704089\"> </a><a name=\"MA-54704089-en-US\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-idmp-regulatedauthorization.html\">IDMP RegulatedAuthorization</a></p></div><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/54704089</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Estalis-Transdermalpatch.html\">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.\nOsteoporoseprophylaxe: 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</a></p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type 756000002001}\">Marketing Authorisation</span></p><p><b>region</b>: <span title=\"Codes:{urn:iso:std:iso:3166 CH}\">Switzerland</span></p><p><b>status</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status 756005023007}\">valid</span></p><p><b>statusDate</b>: 1999-08-17</p><p><b>holder</b>: <a href=\"#hcMA-54704089/holder-Sandoz-Pharmaceuticals-AG\">Organization Sandoz Pharmaceuticals AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-54704089/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG</b></p><a name=\"MA-54704089/holder-Sandoz-Pharmaceuticals-AG\"> </a><a name=\"hcMA-54704089/holder-Sandoz-Pharmaceuticals-AG\"> </a><a name=\"MA-54704089/holder-Sandoz-Pharmaceuticals-AG-en-US\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-epl-organization.html\">CH EPL Organization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-LOC.html\" title=\"Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)\">LOC Identifier</a>/100054743, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7601001029439</p><p><b>name</b>: Sandoz Pharmaceuticals AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name=\"MA-54704089/regulator-SMC\"> </a><a name=\"hcMA-54704089/regulator-SMC\"> </a><a name=\"MA-54704089/regulator-SMC-en-US\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-epl-organization.html\">CH EPL Organization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-LOC.html\" title=\"Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)\">LOC Identifier</a>/100010911, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7601001398511</p><p><b>name</b>: SMC</p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Organization",
"id" : "holder-Sandoz-Pharmaceuticals-AG",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier" : [
{
"system" : "urn:oid:1.2.276.0.76",
"value" : "100054743"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001029439"
}
],
"name" : "Sandoz Pharmaceuticals AG"
},
{
"resourceType" : "Organization",
"id" : "regulator-SMC",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier" : [
{
"system" : "urn:oid:1.2.276.0.76",
"value" : "100010911"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001398511"
}
],
"name" : "SMC"
}
],
"identifier" : [
{
"system" : "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber",
"value" : "54704089"
}
],
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Estalis-Transdermalpatch"
}
],
"type" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type",
"code" : "756000002001",
"display" : "Marketing Authorisation"
}
]
},
"region" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "CH",
"display" : "Switzerland"
}
]
}
],
"status" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status",
"code" : "756005023007",
"display" : "valid"
}
]
},
"statusDate" : "1999-08-17",
"holder" : {
"reference" : "#holder-Sandoz-Pharmaceuticals-AG"
},
"regulator" : {
"reference" : "#regulator-SMC"
}
}