FHIR IG analytics| Package | ch.fhir.ig.ch-idmp |
| Resource Type | MedicinalProductDefinition |
| Id | MedicinalProductDefinition-Xospata-Filmcoatedtablet.json |
| FHIR Version | R5 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: MedicinalProductDefinition Xospata-Filmcoatedtablet
Profile: MedicinalProductDefinition
CH SMC - Authorized Dose Form: Film-coated tablet
identifier: Medical Product Identifier/CH-01100869-0672110010000
indication:
Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden.
legalStatusOfSupply: A: Single dispensing requiring a medical or veterinary prescription
additionalMonitoringIndicator: No Warning
pediatricUseIndicator: Not authorised for the treatment in children
classification: gilteritinib, Synthetic
| Country | Status | DateRange |
| Switzerland | No interruption of distribution reported | 2020-09-24 --> (ongoing) |
attachedDocument:
name
productName: Xospata 40 mg, Filmtabletten
Usages
Country Language Switzerland German (Switzerland)
{
"resourceType": "MedicinalProductDefinition",
"id": "Xospata-Filmcoatedtablet",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-medicinalproductdefinition"
]
},
"text": {
"status": "extensions",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://fhir.ch/ig/ch-idmp/StructureDefinition/authorizedDoseForm",
"valueCodeableConcept": {
"coding": [
{
"system": "http://standardterms.edqm.eu",
"code": "10221000",
"display": "Film-coated tablet"
}
]
}
}
],
"identifier": [
{
"system": "http://fhir.ch/ig/ch-idmp/sid/mpid",
"value": "CH-01100869-0672110010000"
}
],
"indication": "Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden.",
"legalStatusOfSupply": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply",
"code": "756005034000001",
"display": "A: Single dispensing requiring a medical or veterinary prescription"
}
]
},
"additionalMonitoringIndicator": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator",
"code": "756005001003",
"display": "No Warning"
}
]
},
"pediatricUseIndicator": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator",
"code": "756005003002",
"display": "Not authorised for the treatment in children"
}
]
},
"classification": [
{
"coding": [
{
"system": "http://www.whocc.no/atc",
"code": "L01EX13"
}
]
},
{
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory",
"code": "756005039000001",
"display": "Synthetic"
}
]
}
],
"marketingStatus": [
{
"country": {
"coding": [
{
"system": "urn:iso:std:iso:3166",
"code": "CH",
"display": "Switzerland"
}
]
},
"status": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-marketing-status",
"code": "7560050074000003",
"display": "No interruption of distribution reported"
}
]
},
"dateRange": {
"start": "2020-09-24"
}
}
],
"attachedDocument": [
{
"reference": "DocumentReference/DocRef-FI-Xospata"
},
{
"reference": "DocumentReference/DocRef-PI-Xospata"
}
],
"name": [
{
"productName": "Xospata 40 mg, Filmtabletten",
"usage": [
{
"country": {
"coding": [
{
"system": "urn:iso:std:iso:3166",
"code": "CH",
"display": "Switzerland"
}
]
},
"language": {
"coding": [
{
"system": "urn:ietf:bcp:47",
"code": "de-CH"
}
]
}
}
]
}
]
}