FHIR IG analytics| Package | ch.fhir.ig.ch-idmp |
| Resource Type | Bundle |
| Id | Bundle-ab55cf13-a819-4875-adaa-5545e2cbdddf.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
FHIR
FHIRsmith{
"resourceType": "Bundle",
"id": "ab55cf13-a819-4875-adaa-5545e2cbdddf",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-bundle"
]
},
"language": "de-CH",
"type": "collection",
"entry": [
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Xospata-Filmcoatedtablet",
"resource": {
"resourceType": "MedicinalProductDefinition",
"id": "Xospata-Filmcoatedtablet",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-medicinalproductdefinition"
]
},
"text": {
"status": "extensions",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_Xospata-Filmcoatedtablet\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition Xospata-Filmcoatedtablet</b></p><a name=\"Xospata-Filmcoatedtablet\"> </a><a name=\"hcXospata-Filmcoatedtablet\"> </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-medicinalproductdefinition.html\">MedicinalProductDefinition</a></p></div><p><b>CH SMC - Authorized Dose Form</b>: <span title=\"Codes:{http://standardterms.edqm.eu 10221000}\">Film-coated tablet</span></p><p><b>identifier</b>: <a href=\"NamingSystem-MPID.html\" title=\"Temporary Identifier in this implementation guide until officially released by Swissmedic\">Medical Product Identifier</a>/CH-01100869-0672110010000</p><p><b>indication</b>: </p><div><p>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.</p>\n</div><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply 756005034000001}\">A: Single dispensing requiring a medical or veterinary prescription</span></p><p><b>additionalMonitoringIndicator</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator 756005001003}\">No Warning</span></p><p><b>pediatricUseIndicator</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator 756005003002}\">Not authorised for the treatment in children</span></p><p><b>classification</b>: <span title=\"Codes:{http://www.whocc.no/atc L01EX13}\">gilteritinib</span>, <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory 756005039000001}\">Synthetic</span></p><h3>MarketingStatuses</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Status</b></td><td><b>DateRange</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 CH}\">Switzerland</span></td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-marketing-status 7560050074000003}\">No interruption of distribution reported</span></td><td>2020-09-24 --> (ongoing)</td></tr></table><p><b>attachedDocument</b>: </p><ul><li><a href=\"DocumentReference-DocRef-FI-Xospata.html\">DocumentReference: identifier = http://fhir.ch/ig/ch-idmp/sid/attno#Application / Assessment Tracking Number#123456989-initial submission-Example-xyz-123; status = current; type = Information for healthcare professionals; date = 2021-11-09 00:00:00+0000</a></li><li><a href=\"DocumentReference-DocRef-PI-Xospata.html\">DocumentReference: identifier = http://fhir.ch/ig/ch-idmp/sid/attno#Application / Assessment Tracking Number#123456989-initial submission-Example-abc-123; status = current; type = Patient Information; date = 2021-11-09 00:00:00+0000</a></li></ul><blockquote><p><b>name</b></p><p><b>productName</b>: Xospata 40 mg, Filmtabletten</p><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 CH}\">Switzerland</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 de-CH}\">German (Switzerland)</span></td></tr></table></blockquote></div>"
},
"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"
}
]
}
}
]
}
]
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Xospata",
"resource": {
"resourceType": "DocumentReference",
"id": "DocRef-FI-Xospata",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"DocumentReference_DocRef-FI-Xospata\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference DocRef-FI-Xospata</b></p><a name=\"DocRef-FI-Xospata\"> </a><a name=\"hcDocRef-FI-Xospata\"> </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-documentreference.html\">DocumentReference</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-AttNo.html\" title=\"Temporary Namingsystem in this implementation guide until officially released by Swissmedic\">Application / Assessment Tracking Number</a>/123456989-initial submission-Example-xyz-123</p><p><b>status</b>: Current</p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type 756005040000001}\">Information for healthcare professionals</span></p><p><b>date</b>: 2021-11-09 00:00:00+0000</p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Url</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=67211&supportMultipleResults=1\">https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=67211&supportMultipleResults=1</a></td></tr></table></blockquote></div>"
},
"identifier": [
{
"system": "http://fhir.ch/ig/ch-idmp/sid/attno",
"value": "123456989-initial submission-Example-xyz-123"
}
],
"status": "current",
"type": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type",
"code": "756005040000001",
"display": "Information for healthcare professionals"
}
]
},
"date": "2021-11-09T00:00:00Z",
"content": [
{
"attachment": {
"url": "https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=67211&supportMultipleResults=1"
}
}
]
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-PI-Xospata",
"resource": {
"resourceType": "DocumentReference",
"id": "DocRef-PI-Xospata",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"DocumentReference_DocRef-PI-Xospata\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference DocRef-PI-Xospata</b></p><a name=\"DocRef-PI-Xospata\"> </a><a name=\"hcDocRef-PI-Xospata\"> </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-documentreference.html\">DocumentReference</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-AttNo.html\" title=\"Temporary Namingsystem in this implementation guide until officially released by Swissmedic\">Application / Assessment Tracking Number</a>/123456989-initial submission-Example-abc-123</p><p><b>status</b>: Current</p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type 756005040000002}\">Patient Information</span></p><p><b>date</b>: 2021-11-09 00:00:00+0000</p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Language</b></td><td><b>Url</b></td></tr><tr><td style=\"display: none\">*</td><td>German (Switzerland)</td><td><a href=\"https://Swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67211&supportMultipleResults=1\">https://Swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67211&supportMultipleResults=1</a></td></tr></table></blockquote></div>"
},
"identifier": [
{
"system": "http://fhir.ch/ig/ch-idmp/sid/attno",
"value": "123456989-initial submission-Example-abc-123"
}
],
"status": "current",
"type": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type",
"code": "756005040000002",
"display": "Patient Information"
}
]
},
"date": "2021-11-09T00:00:00Z",
"content": [
{
"attachment": {
"language": "de-CH",
"url": "https://Swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67211&supportMultipleResults=1"
}
}
]
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-6721101",
"resource": {
"resourceType": "RegulatedAuthorization",
"id": "MA-6721101",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_MA-6721101\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-6721101</b></p><a name=\"MA-6721101\"> </a><a name=\"hcMA-6721101\"> </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\">RegulatedAuthorization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-AuthNo.html\" title=\"Temporary Identifier in this implementation guide until officially released by Swissmedic\">Marketing Authorisation Number</a>/6721101</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Xospata-Filmcoatedtablet.html\">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#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</a></p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs 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-idmp/CodeSystem/ch-SMC-authorisation-status 756005010000001}\">approved</span></p><p><b>statusDate</b>: 2021-11-09</p><p><b>validityPeriod</b>: 2021-11-09 --> (ongoing)</p><p><b>holder</b>: <a href=\"#hcMA-6721101/holder-Astellas-Pharma-AG\">Organization Astellas Pharma AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-6721101/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Astellas-Pharma-AG</b></p><a name=\"MA-6721101/holder-Astellas-Pharma-AG\"> </a><a name=\"hcMA-6721101/holder-Astellas-Pharma-AG\"> </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-organization.html\">Organization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-SMCLocID.html\" title=\"Temporary NamingSystem in this implementation guide until officially released by Swissmedic\">Swissmedic Location Identifier</a>/01100869, <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>/100010745, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7601001000964</p><p><b>name</b>: Astellas Pharma AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name=\"MA-6721101/regulator-SMC\"> </a><a name=\"hcMA-6721101/regulator-SMC\"> </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-organization.html\">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-Astellas-Pharma-AG",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"
]
},
"identifier": [
{
"system": "https://www.swissmedic.ch/fhir/identifier/locations",
"value": "01100869"
},
{
"system": "https://spor.ema.europa.eu/v1/locations",
"value": "100010745"
},
{
"system": "urn:oid:2.51.1.3",
"value": "7601001000964"
}
],
"name": "Astellas Pharma AG"
},
{
"resourceType": "Organization",
"id": "regulator-SMC",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/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": "SMC"
}
],
"identifier": [
{
"system": "http://fhir.ch/ig/ch-idmp/sid/authno",
"value": "6721101"
}
],
"subject": [
{
"reference": "MedicinalProductDefinition/Xospata-Filmcoatedtablet"
}
],
"type": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs",
"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-idmp/CodeSystem/ch-SMC-authorisation-status",
"code": "756005010000001",
"display": "approved"
}
]
},
"statusDate": "2021-11-09",
"validityPeriod": {
"start": "2021-11-09"
},
"holder": {
"reference": "#holder-Astellas-Pharma-AG"
},
"regulator": {
"reference": "#regulator-SMC"
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet",
"resource": {
"resourceType": "PackagedProductDefinition",
"id": "PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-packagedproductdefinition"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet</b></p><a name=\"PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet\"> </a><a name=\"hcPMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet\"> </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-packagedproductdefinition.html\">PackagedProductDefinition</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-PCID.html\" title=\"Temporary Identifier in this implementation guide until officially released by Swissmedic\">Clinical Product Identifier</a>/CH-01100869-0672110010000-0001</p><p><b>packageFor</b>: <a href=\"MedicinalProductDefinition-Xospata-Filmcoatedtablet.html\">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#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</a></p><p><b>containedItemQuantity</b>: 48 Tablet<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code15054000 = 'Tablet')</span></p><p><b>description</b>: </p><div><p>4 Blister zu 7 Tabletten in 1 Box</p>\n</div><h3>LegalStatusOfSupplies</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply 756005034000001}\">A: Single dispensing requiring a medical or veterinary prescription</span></td></tr></table><h3>MarketingStatuses</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Status</b></td><td><b>DateRange</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 CH}\">Switzerland</span></td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status 756002026002}\">Marketed</span></td><td>2020-09-24 --> (ongoing)</td></tr></table><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <a href=\"http://terminology.hl7.org/7.1.0/NamingSystem-gtin.html\" title=\"The GS1 GTIN is a globally unique identifier of trade items. A trade item is any item (product or service) upon which there is a need to retrieve pre-defined information and that may be priced, or ordered, or invoiced at any point in any supply chain. Note: GTINs may be used in both Codes (http://build.fhir.org/datatypes.html#Coding) and Identifiers (http://build.fhir.org/datatypes.html#Identifier).\">GTIN Global Trade Item Number</a>/7680672110011</p><p><b>type</b>: <span title=\"Codes:{http://standardterms.edqm.eu 30009000}\">Box</span></p><p><b>quantity</b>: 1</p><h3>ShelfLifeStorages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Period[x]</b></td><td><b>SpecialPrecautionsForStorage</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000073343 100000073403}\">Shelf life of the medicinal product as packaged for sale</span></td><td>No display for Duration (value: 36; unit: month; system: http://unitsofmeasure.org; code: mo)</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage 756005041000009}\">Do not store above 30°C</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{http://standardterms.edqm.eu 30007000}\">Blister</span></p><p><b>quantity</b>: 4</p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></td></tr></table><p><b>amount</b>: 12 countable unit(s)<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code1 = '1')</span></p></blockquote></blockquote></blockquote></div>"
},
"identifier": [
{
"system": "http://fhir.ch/ig/ch-idmp/sid/pcid",
"value": "CH-01100869-0672110010000-0001"
}
],
"packageFor": [
{
"reference": "MedicinalProductDefinition/Xospata-Filmcoatedtablet"
}
],
"containedItemQuantity": [
{
"value": 48,
"unit": "Tablet",
"system": "http://standardterms.edqm.eu",
"code": "15054000"
}
],
"description": "4 Blister zu 7 Tabletten in 1 Box",
"legalStatusOfSupply": [
{
"code": {
"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"
}
]
}
}
],
"marketingStatus": [
{
"country": {
"coding": [
{
"system": "urn:iso:std:iso:3166",
"code": "CH",
"display": "Switzerland"
}
]
},
"status": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status",
"code": "756002026002",
"display": "Marketed"
}
]
},
"dateRange": {
"start": "2020-09-24"
}
}
],
"packaging": {
"identifier": [
{
"system": "https://www.gs1.org/gtin",
"value": "7680672110011"
}
],
"type": {
"coding": [
{
"system": "http://standardterms.edqm.eu",
"code": "30009000",
"display": "Box"
}
]
},
"quantity": 1,
"shelfLifeStorage": [
{
"type": {
"coding": [
{
"system": "http://spor.ema.europa.eu/v1/lists/100000073343",
"code": "100000073403",
"display": "Shelf life of the medicinal product as packaged for sale"
}
]
},
"periodDuration": {
"value": 36,
"unit": "month",
"system": "http://unitsofmeasure.org",
"code": "mo"
},
"specialPrecautionsForStorage": [
{
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage",
"code": "756005041000009",
"display": "Do not store above 30°C"
}
]
}
]
}
],
"packaging": [
{
"type": {
"coding": [
{
"system": "http://standardterms.edqm.eu",
"code": "30007000",
"display": "Blister"
}
]
},
"quantity": 4,
"containedItem": [
{
"item": {
"reference": {
"reference": "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
}
},
"amount": {
"value": 12,
"unit": "countable unit(s)",
"system": "http://unitsofmeasure.org",
"code": "1"
}
}
]
}
]
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-67211001",
"resource": {
"resourceType": "RegulatedAuthorization",
"id": "MA-67211001",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_MA-67211001\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-67211001</b></p><a name=\"MA-67211001\"> </a><a name=\"hcMA-67211001\"> </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\">RegulatedAuthorization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-AuthNo.html\" title=\"Temporary Identifier in this implementation guide until officially released by Swissmedic\">Marketing Authorisation Number</a>/67211001</p><p><b>subject</b>: <a href=\"PackagedProductDefinition-PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-idmp/sid/pcid#Clinical Product Identifier#CH-01100869-0672110010000-0001; containedItemQuantity = 48 Tablet; description = 4 Blister zu 7 Tabletten in 1 Box</a></p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs 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-idmp/CodeSystem/ch-SMC-authorisation-status 756005010000001}\">approved</span></p><p><b>statusDate</b>: 2021-11-09</p><p><b>validityPeriod</b>: 2021-11-09 --> (ongoing)</p><p><b>holder</b>: <a href=\"#hcMA-67211001/holder-Astellas-Pharma-AG\">Organization Astellas Pharma AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-67211001/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Astellas-Pharma-AG</b></p><a name=\"MA-67211001/holder-Astellas-Pharma-AG\"> </a><a name=\"hcMA-67211001/holder-Astellas-Pharma-AG\"> </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-organization.html\">Organization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-SMCLocID.html\" title=\"Temporary NamingSystem in this implementation guide until officially released by Swissmedic\">Swissmedic Location Identifier</a>/01100869, <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>/100010745, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7601001000964</p><p><b>name</b>: Astellas Pharma AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name=\"MA-67211001/regulator-SMC\"> </a><a name=\"hcMA-67211001/regulator-SMC\"> </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-organization.html\">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-Astellas-Pharma-AG",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"
]
},
"identifier": [
{
"system": "https://www.swissmedic.ch/fhir/identifier/locations",
"value": "01100869"
},
{
"system": "https://spor.ema.europa.eu/v1/locations",
"value": "100010745"
},
{
"system": "urn:oid:2.51.1.3",
"value": "7601001000964"
}
],
"name": "Astellas Pharma AG"
},
{
"resourceType": "Organization",
"id": "regulator-SMC",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/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": "SMC"
}
],
"identifier": [
{
"system": "http://fhir.ch/ig/ch-idmp/sid/authno",
"value": "67211001"
}
],
"subject": [
{
"reference": "PackagedProductDefinition/PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
}
],
"type": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs",
"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-idmp/CodeSystem/ch-SMC-authorisation-status",
"code": "756005010000001",
"display": "approved"
}
]
},
"statusDate": "2021-11-09",
"validityPeriod": {
"start": "2021-11-09"
},
"holder": {
"reference": "#holder-Astellas-Pharma-AG"
},
"regulator": {
"reference": "#regulator-SMC"
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet",
"resource": {
"resourceType": "ManufacturedItemDefinition",
"id": "MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-manufactureditemdefinition"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ManufacturedItemDefinition_MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet</b></p><a name=\"MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet\"> </a><a name=\"hcMI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet\"> </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-manufactureditemdefinition.html\">ManufacturedItemDefinition</a></p></div><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{http://standardterms.edqm.eu 10221000}\">Film-coated tablet</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{http://standardterms.edqm.eu 15054000}\">Tablet</span></p></div>"
},
"status": "active",
"manufacturedDoseForm": {
"coding": [
{
"system": "http://standardterms.edqm.eu",
"code": "10221000",
"display": "Film-coated tablet"
}
]
},
"unitOfPresentation": {
"coding": [
{
"system": "http://standardterms.edqm.eu",
"code": "15054000",
"display": "Tablet"
}
]
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet",
"resource": {
"resourceType": "AdministrableProductDefinition",
"id": "PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-administrableproductdefinition"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"AdministrableProductDefinition_PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet</b></p><a name=\"PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet\"> </a><a name=\"hcPhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet\"> </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-administrableproductdefinition.html\">AdministrableProductDefinition</a></p></div><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"MedicinalProductDefinition-Xospata-Filmcoatedtablet.html\">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#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</a></p><p><b>administrableDoseForm</b>: <span title=\"Codes:{http://standardterms.edqm.eu 10221000}\">Film-coated tablet</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{http://standardterms.edqm.eu 15054000}\">Tablet</span></p><h3>RouteOfAdministrations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://standardterms.edqm.eu 20053000}\">Oral use</span></td></tr></table></div>"
},
"status": "active",
"formOf": [
{
"reference": "MedicinalProductDefinition/Xospata-Filmcoatedtablet"
}
],
"administrableDoseForm": {
"coding": [
{
"system": "http://standardterms.edqm.eu",
"code": "10221000",
"display": "Film-coated tablet"
}
]
},
"unitOfPresentation": {
"coding": [
{
"system": "http://standardterms.edqm.eu",
"code": "15054000",
"display": "Tablet"
}
]
},
"routeOfAdministration": [
{
"code": {
"coding": [
{
"system": "http://standardterms.edqm.eu",
"code": "20053000",
"display": "Oral use"
}
]
}
}
]
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/Ingredient/GilteritinibiHemifumaras40",
"resource": {
"resourceType": "Ingredient",
"id": "GilteritinibiHemifumaras40",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_GilteritinibiHemifumaras40\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient GilteritinibiHemifumaras40</b></p><a name=\"GilteritinibiHemifumaras40\"> </a><a name=\"hcGilteritinibiHemifumaras40\"> </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-ingredient.html\">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href=\"ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000001}\">Active</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance 5RZZ0Z1GJT}\">Gilteritinib fumarate</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>presentation</b>: 44.2 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span>/1 tablet<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code15054000 = 'Tablet')</span></p><blockquote><p><b>referenceStrength</b></p><h3>Substances</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance 66D92MGC8M}\">Gilteritinib</span></td></tr></table><p><b>strength</b>: 40 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span>/1 tablet<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code15054000 = 'Tablet')</span></p></blockquote></blockquote></blockquote></div>"
},
"status": "active",
"for": [
{
"reference": "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
},
{
"reference": "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
}
],
"role": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role",
"code": "756005035000001",
"display": "Active"
}
]
},
"substance": {
"code": {
"concept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code": "5RZZ0Z1GJT",
"display": "Gilteritinib fumarate"
}
]
}
},
"strength": [
{
"presentationRatio": {
"numerator": {
"value": 44.2,
"unit": "mg",
"system": "http://unitsofmeasure.org",
"code": "mg"
},
"denominator": {
"value": 1,
"unit": "tablet",
"system": "http://standardterms.edqm.eu",
"code": "15054000"
}
},
"referenceStrength": [
{
"substance": {
"concept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code": "66D92MGC8M",
"display": "Gilteritinib"
}
]
}
},
"strengthRatio": {
"numerator": {
"value": 40,
"unit": "mg",
"system": "http://unitsofmeasure.org",
"code": "mg"
},
"denominator": {
"value": 1,
"unit": "tablet",
"system": "http://standardterms.edqm.eu",
"code": "15054000"
}
}
}
]
}
]
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/Ingredient/Mannitolum",
"resource": {
"resourceType": "Ingredient",
"id": "Mannitolum",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_Mannitolum\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient Mannitolum</b></p><a name=\"Mannitolum\"> </a><a name=\"hcMannitolum\"> </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-ingredient.html\">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href=\"ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}\">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance 3OWL53L36A}\">Mannitol</span></td></tr></table></blockquote></div>"
},
"status": "active",
"for": [
{
"reference": "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
},
{
"reference": "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
}
],
"role": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role",
"code": "756005035000002",
"display": "Excipient"
}
]
},
"substance": {
"code": {
"concept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code": "3OWL53L36A",
"display": "Mannitol"
}
]
}
}
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/Ingredient/Hydroxypropylcellulosum",
"resource": {
"resourceType": "Ingredient",
"id": "Hydroxypropylcellulosum",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_Hydroxypropylcellulosum\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient Hydroxypropylcellulosum</b></p><a name=\"Hydroxypropylcellulosum\"> </a><a name=\"hcHydroxypropylcellulosum\"> </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-ingredient.html\">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href=\"ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}\">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance 9XZ8H6N6OH}\">Hyprolose</span></td></tr></table></blockquote></div>"
},
"status": "active",
"for": [
{
"reference": "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
},
{
"reference": "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
}
],
"role": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role",
"code": "756005035000002",
"display": "Excipient"
}
]
},
"substance": {
"code": {
"concept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code": "9XZ8H6N6OH",
"display": "Hyprolose"
}
]
}
}
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/Ingredient/HydroxypropylcellulosumSubstitutumHumile",
"resource": {
"resourceType": "Ingredient",
"id": "HydroxypropylcellulosumSubstitutumHumile",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_HydroxypropylcellulosumSubstitutumHumile\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient HydroxypropylcellulosumSubstitutumHumile</b></p><a name=\"HydroxypropylcellulosumSubstitutumHumile\"> </a><a name=\"hcHydroxypropylcellulosumSubstitutumHumile\"> </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-ingredient.html\">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href=\"ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}\">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance 2165RE0K14}\">Hydroxypropylcellulose, low-substituted</span></td></tr></table></blockquote></div>"
},
"status": "active",
"for": [
{
"reference": "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
},
{
"reference": "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
}
],
"role": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role",
"code": "756005035000002",
"display": "Excipient"
}
]
},
"substance": {
"code": {
"concept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code": "2165RE0K14",
"display": "Hydroxypropylcellulose, low-substituted"
}
]
}
}
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/Ingredient/Talcum",
"resource": {
"resourceType": "Ingredient",
"id": "Talcum",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_Talcum\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient Talcum</b></p><a name=\"Talcum\"> </a><a name=\"hcTalcum\"> </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-ingredient.html\">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href=\"ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}\">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance 7SEV7J4R1U}\">Talc</span></td></tr></table></blockquote></div>"
},
"status": "active",
"for": [
{
"reference": "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
},
{
"reference": "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
}
],
"role": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role",
"code": "756005035000002",
"display": "Excipient"
}
]
},
"substance": {
"code": {
"concept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code": "7SEV7J4R1U",
"display": "Talc"
}
]
}
}
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/Ingredient/Macrogolum8000",
"resource": {
"resourceType": "Ingredient",
"id": "Macrogolum8000",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_Macrogolum8000\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient Macrogolum8000</b></p><a name=\"Macrogolum8000\"> </a><a name=\"hcMacrogolum8000\"> </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-ingredient.html\">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href=\"ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}\">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance Q662QK8M3B}\">Macrogol 8000</span></td></tr></table></blockquote></div>"
},
"status": "active",
"for": [
{
"reference": "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
},
{
"reference": "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
}
],
"role": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role",
"code": "756005035000002",
"display": "Excipient"
}
]
},
"substance": {
"code": {
"concept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code": "Q662QK8M3B",
"display": "Macrogol 8000"
}
]
}
}
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/Ingredient/E171",
"resource": {
"resourceType": "Ingredient",
"id": "E171",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_E171\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient E171</b></p><a name=\"E171\"> </a><a name=\"hcE171\"> </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-ingredient.html\">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href=\"ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}\">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance 15FIX9V2JP}\">Titanium dioxide</span></td></tr></table></blockquote></div>"
},
"status": "active",
"for": [
{
"reference": "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
},
{
"reference": "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
}
],
"role": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role",
"code": "756005035000002",
"display": "Excipient"
}
]
},
"substance": {
"code": {
"concept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code": "15FIX9V2JP",
"display": "Titanium dioxide"
}
]
}
}
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/Ingredient/E172Flavum",
"resource": {
"resourceType": "Ingredient",
"id": "E172Flavum",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_E172Flavum\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient E172Flavum</b></p><a name=\"E172Flavum\"> </a><a name=\"hcE172Flavum\"> </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-ingredient.html\">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href=\"ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}\">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance 15FIX9V2JP}\">Titanium dioxide</span></td></tr></table></blockquote></div>"
},
"status": "active",
"for": [
{
"reference": "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
},
{
"reference": "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
}
],
"role": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role",
"code": "756005035000002",
"display": "Excipient"
}
]
},
"substance": {
"code": {
"concept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code": "15FIX9V2JP",
"display": "Titanium dioxide"
}
]
}
}
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/Ingredient/MagnesiumStearate",
"resource": {
"resourceType": "Ingredient",
"id": "MagnesiumStearate",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_MagnesiumStearate\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient MagnesiumStearate</b></p><a name=\"MagnesiumStearate\"> </a><a name=\"hcMagnesiumStearate\"> </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-ingredient.html\">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href=\"ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}\">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance 70097M6I30}\">Magnesium stearate</span></td></tr></table></blockquote></div>"
},
"status": "active",
"for": [
{
"reference": "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
},
{
"reference": "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
}
],
"role": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role",
"code": "756005035000002",
"display": "Excipient"
}
]
},
"substance": {
"code": {
"concept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code": "70097M6I30",
"display": "Magnesium stearate"
}
]
}
}
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/Ingredient/Hypromellosum",
"resource": {
"resourceType": "Ingredient",
"id": "Hypromellosum",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_Hypromellosum\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient Hypromellosum</b></p><a name=\"Hypromellosum\"> </a><a name=\"hcHypromellosum\"> </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-ingredient.html\">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href=\"ManufacturedItemDefinition-MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}\">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance 3NXW29V3WO}\">Hypromellose</span></td></tr></table></blockquote></div>"
},
"status": "active",
"for": [
{
"reference": "AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
},
{
"reference": "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
}
],
"role": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role",
"code": "756005035000002",
"display": "Excipient"
}
]
},
"substance": {
"code": {
"concept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code": "3NXW29V3WO",
"display": "Hypromellose"
}
]
}
}
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10081514",
"resource": {
"resourceType": "ClinicalUseDefinition",
"id": "IND-10081514",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_IND-10081514\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10081514</b></p><a name=\"IND-10081514\"> </a><a name=\"hcIND-10081514\"> </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-clinicalusedefinition-indication.html\">ClinicalUseDefinition Indication</a></p></div><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Xospata-Filmcoatedtablet.html\">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#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</a></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://www.meddra.org 10081514}\">Acute myeloid leukemia refractory</span></td></tr></table><h3>IntendedEffects</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000003186 756005042000002}\">therapeutic</span></td></tr></table></blockquote></div>"
},
"type": "indication",
"subject": [
{
"reference": "MedicinalProductDefinition/Xospata-Filmcoatedtablet"
}
],
"indication": {
"diseaseSymptomProcedure": {
"concept": {
"coding": [
{
"system": "https://www.meddra.org",
"code": "10081514",
"display": "Acute myeloid leukemia refractory"
}
]
}
},
"intendedEffect": {
"concept": {
"coding": [
{
"system": "http://spor.ema.europa.eu/v1/lists/200000003186",
"code": "756005042000002",
"display": "therapeutic"
}
]
}
}
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10081513",
"resource": {
"resourceType": "ClinicalUseDefinition",
"id": "IND-10081513",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_IND-10081513\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10081513</b></p><a name=\"IND-10081513\"> </a><a name=\"hcIND-10081513\"> </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-clinicalusedefinition-indication.html\">ClinicalUseDefinition Indication</a></p></div><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Xospata-Filmcoatedtablet.html\">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#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</a></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://www.meddra.org 10081513}\">Acute myeloid leukaemia refractory</span></td></tr></table><h3>IntendedEffects</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000003186 756005042000002}\">therapeutic</span></td></tr></table></blockquote></div>"
},
"type": "indication",
"subject": [
{
"reference": "MedicinalProductDefinition/Xospata-Filmcoatedtablet"
}
],
"indication": {
"diseaseSymptomProcedure": {
"concept": {
"coding": [
{
"system": "https://www.meddra.org",
"code": "10081513",
"display": "Acute myeloid leukaemia refractory"
}
]
}
},
"intendedEffect": {
"concept": {
"coding": [
{
"system": "http://spor.ema.europa.eu/v1/lists/200000003186",
"code": "756005042000002",
"display": "therapeutic"
}
]
}
}
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10059034",
"resource": {
"resourceType": "ClinicalUseDefinition",
"id": "IND-10059034",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_IND-10059034\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10059034</b></p><a name=\"IND-10059034\"> </a><a name=\"hcIND-10059034\"> </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-clinicalusedefinition-indication.html\">ClinicalUseDefinition Indication</a></p></div><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Xospata-Filmcoatedtablet.html\">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#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</a></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://www.meddra.org 10059034}\">Acute myeloid leukaemia recurrent</span></td></tr></table><h3>IntendedEffects</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000003186 756005042000002}\">therapeutic</span></td></tr></table></blockquote></div>"
},
"type": "indication",
"subject": [
{
"reference": "MedicinalProductDefinition/Xospata-Filmcoatedtablet"
}
],
"indication": {
"diseaseSymptomProcedure": {
"concept": {
"coding": [
{
"system": "https://www.meddra.org",
"code": "10059034",
"display": "Acute myeloid leukaemia recurrent"
}
]
}
},
"intendedEffect": {
"concept": {
"coding": [
{
"system": "http://spor.ema.europa.eu/v1/lists/200000003186",
"code": "756005042000002",
"display": "therapeutic"
}
]
}
}
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10060558",
"resource": {
"resourceType": "ClinicalUseDefinition",
"id": "IND-10060558",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_IND-10060558\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10060558</b></p><a name=\"IND-10060558\"> </a><a name=\"hcIND-10060558\"> </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-clinicalusedefinition-indication.html\">ClinicalUseDefinition Indication</a></p></div><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Xospata-Filmcoatedtablet.html\">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#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</a></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://www.meddra.org 10060558}\">Acute myeloid leukemia recurrent</span></td></tr></table><h3>IntendedEffects</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000003186 756005042000002}\">therapeutic</span></td></tr></table></blockquote></div>"
},
"type": "indication",
"subject": [
{
"reference": "MedicinalProductDefinition/Xospata-Filmcoatedtablet"
}
],
"indication": {
"diseaseSymptomProcedure": {
"concept": {
"coding": [
{
"system": "https://www.meddra.org",
"code": "10060558",
"display": "Acute myeloid leukemia recurrent"
}
]
}
},
"intendedEffect": {
"concept": {
"coding": [
{
"system": "http://spor.ema.europa.eu/v1/lists/200000003186",
"code": "756005042000002",
"display": "therapeutic"
}
]
}
}
}
}
},
{
"fullUrl": "http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10084619",
"resource": {
"resourceType": "ClinicalUseDefinition",
"id": "IND-10084619",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_IND-10084619\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10084619</b></p><a name=\"IND-10084619\"> </a><a name=\"hcIND-10084619\"> </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-clinicalusedefinition-indication.html\">ClinicalUseDefinition Indication</a></p></div><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Xospata-Filmcoatedtablet.html\">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#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</a></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://www.meddra.org 10084619}\">FLT3-Gen-Mutation</span></td></tr></table><h3>IntendedEffects</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000003186 756005042000002}\">therapeutic</span></td></tr></table></blockquote></div>"
},
"type": "indication",
"subject": [
{
"reference": "MedicinalProductDefinition/Xospata-Filmcoatedtablet"
}
],
"indication": {
"diseaseSymptomProcedure": {
"concept": {
"coding": [
{
"system": "https://www.meddra.org",
"code": "10084619",
"display": "FLT3-Gen-Mutation"
}
]
}
},
"intendedEffect": {
"concept": {
"coding": [
{
"system": "http://spor.ema.europa.eu/v1/lists/200000003186",
"code": "756005042000002",
"display": "therapeutic"
}
]
}
}
}
}
}
]
}