{ "resourceType" : "RegulatedAuthorization", "id" : "MA-52042011", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"] }, "text" : { "status" : "generated", "div" : "

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" : [{ "resourceType" : "Organization", "id" : "holder-Tillotts-Pharma-AG", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization"] }, "identifier" : [{ "system" : "https://www.swissmedic.ch/fhir/identifier/locations", "value" : "01002393" }, { "system" : "https://spor.ema.europa.eu/v1/locations", "value" : "100005174" }, { "system" : "urn:oid:2.51.1.3", "value" : "7601001346451" }], "name" : "Tillotts Pharma AG" }, { "resourceType" : "Organization", "id" : "regulator-SMC", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization"] }, "identifier" : [{ "system" : "https://spor.ema.europa.eu/v1/locations", "value" : "100010911" }, { "system" : "urn:oid:2.51.1.3", "value" : "7601001398511" }], "name" : "Swissmedic Swiss Agency for Therapeutic Products" }], "identifier" : [{ "system" : "http://fhir.ch/ig/ch-epl/sid/authno", "value" : "52042011" }], "subject" : [{ "reference" : "MedicinalProductDefinition/Entocort-Solvent-and-Tablet" }], "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" : "1993-06-18", "holder" : { "reference" : "#holder-Tillotts-Pharma-AG" }, "regulator" : { "reference" : "#regulator-SMC" } }