FHIR IG analytics| Package | ch.fhir.ig.ch-epl |
| Resource Type | Bundle |
| Id | Bundle-08f553cb-1404-4972-bf14-2023a5f59955.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
FHIR
FHIRsmith{
"resourceType": "Bundle",
"id": "08f553cb-1404-4972-bf14-2023a5f59955",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle"
]
},
"type": "collection",
"entry": [
{
"fullUrl": "http://fhir.epl.bag.admin.ch/CHIDMPMedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet",
"resource": {
"resourceType": "MedicinalProductDefinition",
"id": "Cuprior-150mg-Filmcoatedtablet",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition"
]
},
"text": {
"status": "extensions",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_Cuprior-150mg-Filmcoatedtablet\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition Cuprior-150mg-Filmcoatedtablet</b></p><a name=\"Cuprior-150mg-Filmcoatedtablet\"> </a><a name=\"hcCuprior-150mg-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\">IDMP 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-7640109110007-6771901</p><p><b>indication</b>: </p><div><p>Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.</p>\n</div><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply 756005022003}\">Medicinal product subject to medical or veterinary prescription (B)</span></p><p><b>additionalMonitoringIndicator</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-additional-monitoring-indicator 756005001003}\">No Warning</span></p><p><b>pediatricUseIndicator</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-pediatric-use-indicator 756005003001}\">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-epl/CodeSystem/ch-SMC-authorisation-category 756005021001}\">NA KAS art. 12 para. 5 TPLO</span>, <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode 756005004001}\">Synthetic</span>, <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type 756001003002}\">Originator product</span>, <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus 070000}\">07. STOFFWECHSEL</span>, <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus 079900}\">07.99. Varia</span></p><p><b>attachedDocument</b>: </p><ul><li><a href=\"DocumentReference-DocRef-FI-Cuprior.html\">DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-abc-123; status = current; type = Fachinformation; date = 2020-09-01 00:00:00+0000</a></li><li><a href=\"DocumentReference-DocRef-PI-Cuprior.html\">DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-abc-321; status = current; type = Patienteninformation; date = 2020-09-01 00:00:00+0000</a></li></ul><blockquote><p><b>name</b></p><p><b>productName</b>: Cuprior 150 mg, Filmtabletten</p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-medicinal-product-name-type SMC}\">Zugelassener Arzneimittelname</span></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-epl/StructureDefinition/authorizedDoseForm",
"valueCodeableConcept": {
"coding": [
{
"system": "http://standardterms.edqm.eu",
"code": "10221000",
"display": "Film-coated tablet"
}
]
}
}
],
"identifier": [
{
"system": "http://fhir.ch/ig/ch-epl/sid/mpid",
"value": "CH-7640109110007-6771901"
}
],
"indication": "Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.",
"legalStatusOfSupply": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply",
"code": "756005022003",
"display": "Medicinal product subject to medical or veterinary prescription (B)"
}
]
},
"additionalMonitoringIndicator": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-additional-monitoring-indicator",
"code": "756005001003",
"display": "No Warning"
}
]
},
"pediatricUseIndicator": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-pediatric-use-indicator",
"code": "756005003001",
"display": "Authorised for the treatment in children"
}
]
},
"classification": [
{
"coding": [
{
"system": "http://www.whocc.no/atc",
"code": "L01EX13"
}
]
},
{
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-category",
"code": "756005021001",
"display": "NA KAS art. 12 para. 5 TPLO"
}
]
},
{
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode",
"code": "756005004001",
"display": "Synthetic"
}
]
},
{
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type",
"code": "756001003002",
"display": "Originator product"
}
]
},
{
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus",
"code": "070000",
"display": "07. STOFFWECHSEL"
}
]
},
{
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus",
"code": "079900",
"display": "07.99. Varia"
}
]
}
],
"attachedDocument": [
{
"reference": "DocumentReference/DocRef-FI-Cuprior"
},
{
"reference": "DocumentReference/DocRef-PI-Cuprior"
}
],
"name": [
{
"productName": "Cuprior 150 mg, Filmtabletten",
"type": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-medicinal-product-name-type",
"code": "SMC",
"display": "Zugelassener Arzneimittelname"
}
]
},
"usage": [
{
"country": {
"coding": [
{
"system": "urn:iso:std:iso:3166",
"code": "CH",
"display": "Switzerland"
}
]
},
"language": {
"coding": [
{
"system": "urn:ietf:bcp:47",
"code": "de-CH",
"display": "German (Switzerland)"
}
]
}
}
]
}
]
}
},
{
"fullUrl": "http://fhir.epl.bag.admin.ch/CHIDMPDocumentReference/DocRef-FI-Cuprior",
"resource": {
"resourceType": "DocumentReference",
"id": "DocRef-FI-Cuprior",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference"
]
},
"language": "de-CH",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"de-CH\" lang=\"de-CH\"><a name=\"DocumentReference_DocRef-FI-Cuprior\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference DocRef-FI-Cuprior</b></p><a name=\"DocRef-FI-Cuprior\"> </a><a name=\"hcDocRef-FI-Cuprior\"> </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\">Language: de-CH</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-idmp-documentreference.html\">CH IDMP 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>/123456789-initial submission-Example-abc-123</p><p><b>status</b>: Current</p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type 756005007001}\">Fachinformation</span></p><p><b>date</b>: 2020-09-01 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=67719&supportMultipleResults=1\">https://swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=67719&supportMultipleResults=1</a></td></tr></table></blockquote></div>"
},
"identifier": [
{
"system": "http://fhir.ch/ig/ch-epl/sid/attno",
"value": "123456789-initial submission-Example-abc-123"
}
],
"status": "current",
"type": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type",
"code": "756005007001",
"display": "Fachinformation"
}
]
},
"date": "2020-09-01T00:00:00Z",
"content": [
{
"attachment": {
"url": "https://swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=67719&supportMultipleResults=1"
}
}
]
}
},
{
"fullUrl": "http://fhir.epl.bag.admin.ch/CHIDMPDocumentReference/DocRef-PI-Cuprior",
"resource": {
"resourceType": "DocumentReference",
"id": "DocRef-PI-Cuprior",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference"
]
},
"language": "de-CH",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"de-CH\" lang=\"de-CH\"><a name=\"DocumentReference_DocRef-PI-Cuprior\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference DocRef-PI-Cuprior</b></p><a name=\"DocRef-PI-Cuprior\"> </a><a name=\"hcDocRef-PI-Cuprior\"> </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\">Language: de-CH</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-idmp-documentreference.html\">CH IDMP 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>/123456789-initial submission-Example-abc-321</p><p><b>status</b>: Current</p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type 756005007002}\">Patienteninformation</span></p><p><b>date</b>: 2020-09-01 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=PI&lang=DE&authNr=67719&supportMultipleResults=1\">https://swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67719&supportMultipleResults=1</a></td></tr></table></blockquote></div>"
},
"identifier": [
{
"system": "http://fhir.ch/ig/ch-epl/sid/attno",
"value": "123456789-initial submission-Example-abc-321"
}
],
"status": "current",
"type": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type",
"code": "756005007002",
"display": "Patienteninformation"
}
]
},
"date": "2020-09-01T00:00:00Z",
"content": [
{
"attachment": {
"url": "https://swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67719&supportMultipleResults=1"
}
}
]
}
},
{
"fullUrl": "http://fhir.epl.bag.admin.ch/CHIDMPRegulatedAuthorisation/MA-6771901",
"resource": {
"resourceType": "RegulatedAuthorization",
"id": "MA-6771901",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_MA-6771901\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-6771901</b></p><a name=\"MA-6771901\"> </a><a name=\"hcMA-6771901\"> </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>: <a href=\"NamingSystem-AuthNo.html\" title=\"Temporary Identifier in this implementation guide until officially released by Swissmedic\">Marketing Authorisation Number</a>/6771901</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Cuprior-150mg-Filmcoatedtablet.html\">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-7640109110007-6771901; indication = Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia</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>: 2021-01-21</p><p><b>holder</b>: <a href=\"#hcMA-6771901/holder-Curatis-AG\">Organization Curatis AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-6771901/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Curatis-AG</b></p><a name=\"MA-6771901/holder-Curatis-AG\"> </a><a name=\"hcMA-6771901/holder-Curatis-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-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>/100082791, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7640109110007</p><p><b>name</b>: Curatis AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name=\"MA-6771901/regulator-SMC\"> </a><a name=\"hcMA-6771901/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-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-Curatis-AG",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier": [
{
"system": "urn:oid:1.2.276.0.76",
"value": "100082791"
},
{
"system": "urn:oid:2.51.1.3",
"value": "7640109110007"
}
],
"name": "Curatis 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://fhir.ch/ig/ch-epl/sid/authno",
"value": "6771901"
}
],
"subject": [
{
"reference": "MedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet"
}
],
"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": "2021-01-21",
"holder": {
"reference": "#holder-Curatis-AG"
},
"regulator": {
"reference": "#regulator-SMC"
}
}
},
{
"fullUrl": "http://fhir.epl.bag.admin.ch/CHIDMPPackagedProductDefinition/PMP-Cuprior-150mg-Filmcoatedtablet",
"resource": {
"resourceType": "PackagedProductDefinition",
"id": "PMP-Cuprior-150mg-Filmcoatedtablet",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_PMP-Cuprior-150mg-Filmcoatedtablet\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition PMP-Cuprior-150mg-Filmcoatedtablet</b></p><a name=\"PMP-Cuprior-150mg-Filmcoatedtablet\"> </a><a name=\"hcPMP-Cuprior-150mg-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\">IDMP 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-7640109110007-6771901-001</p><p><b>packageFor</b>: <a href=\"MedicinalProductDefinition-Cuprior-150mg-Filmcoatedtablet.html\">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-7640109110007-6771901; indication = Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia</a></p><p><b>containedItemQuantity</b>: 72 Tablet<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code15054000 = 'Tablet')</span></p><p><b>description</b>: </p><div><p>CUPRIOR Filmtabl 150 mg 72 Stk</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-epl/CodeSystem/ch-SMC-legal-status-of-supply 756005022003}\">Medicinal product subject to medical or veterinary prescription (B)</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <a href=\"NamingSystem-GTIN.html\" title=\"GS1 defines trade items as products or services that are priced, ordered or invoiced at any point in the supply chain.\">Global Trade Item Number</a>/7680677190018</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-epl/CodeSystem/ch-SMC-special-precautions-for-storage 756005042009}\">Do not store above 30°C</span></td></tr></table></blockquote><h3>Characteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-other-characteristics-type 756000003001}\">Package Size Type</span></td><td><span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-other-characteristics-packaged-item 756005041001}\">Modal pack</span></td></tr></table></div>"
},
"identifier": [
{
"system": "http://fhir.ch/ig/ch-epl/sid/pcid",
"value": "CH-7640109110007-6771901-001"
}
],
"packageFor": [
{
"reference": "MedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet"
}
],
"containedItemQuantity": [
{
"value": 72,
"unit": "Tablet",
"system": "http://standardterms.edqm.eu",
"code": "15054000"
}
],
"description": "CUPRIOR Filmtabl 150 mg 72 Stk",
"legalStatusOfSupply": [
{
"code": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply",
"code": "756005022003",
"display": "Medicinal product subject to medical or veterinary prescription (B)"
}
]
}
}
],
"packaging": {
"identifier": [
{
"system": "urn:oid:2.51.1.1",
"value": "7680677190018"
}
],
"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-epl/CodeSystem/ch-SMC-special-precautions-for-storage",
"code": "756005042009",
"display": "Do not store above 30°C"
}
]
}
]
}
]
},
"characteristic": [
{
"type": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-other-characteristics-type",
"code": "756000003001",
"display": "Package Size Type"
}
]
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-other-characteristics-packaged-item",
"code": "756005041001",
"display": "Modal pack"
}
]
}
}
]
}
},
{
"fullUrl": "http://fhir.epl.bag.admin.ch/CHIDMPRegulatedAuthorization/MA-67719001",
"resource": {
"resourceType": "RegulatedAuthorization",
"id": "MA-67719001",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_MA-67719001\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-67719001</b></p><a name=\"MA-67719001\"> </a><a name=\"hcMA-67719001\"> </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>: <a href=\"NamingSystem-AuthNo.html\" title=\"Temporary Identifier in this implementation guide until officially released by Swissmedic\">Marketing Authorisation Number</a>/67719001</p><p><b>subject</b>: <a href=\"PackagedProductDefinition-PMP-Cuprior-150mg-Filmcoatedtablet.html\">PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-7640109110007-6771901-001; containedItemQuantity = 72 Tablet; description = CUPRIOR Filmtabl 150 mg 72 Stk</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>: 2021-01-21</p><p><b>holder</b>: <a href=\"#hcMA-67719001/holder-Curatis-AG\">Organization Curatis AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-67719001/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Curatis-AG</b></p><a name=\"MA-67719001/holder-Curatis-AG\"> </a><a name=\"hcMA-67719001/holder-Curatis-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-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>/100082791, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7640109110007</p><p><b>name</b>: Curatis AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name=\"MA-67719001/regulator-SMC\"> </a><a name=\"hcMA-67719001/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-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-Curatis-AG",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier": [
{
"system": "urn:oid:1.2.276.0.76",
"value": "100082791"
},
{
"system": "urn:oid:2.51.1.3",
"value": "7640109110007"
}
],
"name": "Curatis 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://fhir.ch/ig/ch-epl/sid/authno",
"value": "67719001"
}
],
"subject": [
{
"reference": "PackagedProductDefinition/PMP-Cuprior-150mg-Filmcoatedtablet"
}
],
"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": "2021-01-21",
"holder": {
"reference": "#holder-Curatis-AG"
},
"regulator": {
"reference": "#regulator-SMC"
}
}
},
{
"fullUrl": "http://fhir.epl.bag.admin.ch/CHIDMPRegulatedAuthorization/FOPH-21208",
"resource": {
"resourceType": "RegulatedAuthorization",
"id": "FOPH-21208",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"
]
},
"text": {
"status": "extensions",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_FOPH-21208\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization FOPH-21208</b></p><a name=\"FOPH-21208\"> </a><a name=\"hcFOPH-21208\"> </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><blockquote><p><b>CH - EPL Reimbursement SL</b></p><blockquote><p><b>url</b></p>FOPHDossierNumber</blockquote><p><b>value</b>: <a href=\"NamingSystem-Dossier.html\" title=\"Identifier holding the Dossier number of FOPH\">FOPH Dossier Number</a>/21208</p><blockquote><p><b>url</b></p>status</blockquote><p><b>value</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status 756001021001}\">Reimbursed</span></p><blockquote><p><b>url</b></p>statusDate</blockquote><p><b>value</b>: 2021-08-01</p><blockquote><p><b>url</b></p>listingStatus</blockquote><p><b>value</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status 756001002001}\">Listed</span></p><blockquote><p><b>url</b></p>listingPeriod</blockquote><p><b>value</b>: 2021-08-01 --> (ongoing)</p><blockquote><p><b>url</b></p>firstListingDate</blockquote><p><b>value</b>: 2021-08-01</p><blockquote><p><b>url</b></p>costShare</blockquote><p><b>value</b>: 10</p><blockquote><p><b>url</b></p>gamme</blockquote><p><b>value</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme 756002004001}\">Oral</span></p><p><b>value</b>: <span title=\"Swiss Franc\">CHF3,022.10</span> (CHF)</p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type 756002005002}\">Ex-factory price</span></p><p><b>changeType</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change 756002006007}\">Price mutation after triennal review of pharmaceuticals</span></p><p><b>changeDate</b>: 2024-01-01</p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-productPrice.html\">CH - EPL Product Price</a></blockquote><p><b>value</b>: <span title=\"Swiss Franc\">CHF3,347.10</span> (CHF)</p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type 756002005001}\">Retail price</span></p><p><b>changeType</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change 756002006005}\">VAT-change</span></p><p><b>changeDate</b>: 2024-01-01</p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-productPrice.html\">CH - EPL Product Price</a></blockquote></blockquote><p><b>subject</b>: <a href=\"PackagedProductDefinition-PMP-Cuprior-150mg-Filmcoatedtablet.html\">PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-7640109110007-6771901-001; containedItemQuantity = 72 Tablet; description = CUPRIOR Filmtabl 150 mg 72 Stk</a></p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type 756000002003}\">Reimbursement SL</span></p><h3>Indications</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td/><td><a href=\"ClinicalUseDefinition-IND-10061091.html\">ClinicalUseDefinition: type = indication</a></td></tr></table><p><b>holder</b>: <a href=\"#hcFOPH-21208/holder-Curatis-AG\">Organization Curatis AG</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Curatis-AG</b></p><a name=\"FOPH-21208/holder-Curatis-AG\"> </a><a name=\"hcFOPH-21208/holder-Curatis-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-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>/100082791, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7640109110007</p><p><b>name</b>: Curatis AG</p></blockquote></div>"
},
"contained": [
{
"resourceType": "Organization",
"id": "holder-Curatis-AG",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier": [
{
"system": "urn:oid:1.2.276.0.76",
"value": "100082791"
},
{
"system": "urn:oid:2.51.1.3",
"value": "7640109110007"
}
],
"name": "Curatis AG"
}
],
"extension": [
{
"extension": [
{
"url": "FOPHDossierNumber",
"valueIdentifier": {
"system": "urn:oid:2.16.756.1",
"value": "21208"
}
},
{
"url": "status",
"valueCodeableConcept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status",
"code": "756001021001",
"display": "Reimbursed"
}
]
}
},
{
"url": "statusDate",
"valueDate": "2021-08-01"
},
{
"url": "listingStatus",
"valueCodeableConcept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status",
"code": "756001002001",
"display": "Listed"
}
]
}
},
{
"url": "listingPeriod",
"valuePeriod": {
"start": "2021-08-01"
}
},
{
"url": "firstListingDate",
"valueDate": "2021-08-01"
},
{
"url": "costShare",
"valueInteger": 10
},
{
"url": "gamme",
"valueCodeableConcept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme",
"code": "756002004001",
"display": "Oral"
}
]
}
},
{
"extension": [
{
"url": "value",
"valueMoney": {
"value": 3022.1,
"currency": "CHF"
}
},
{
"url": "type",
"valueCodeableConcept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type",
"code": "756002005002",
"display": "Ex-factory price"
}
]
}
},
{
"url": "changeType",
"valueCodeableConcept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change",
"code": "756002006007",
"display": "Price mutation after triennal review of pharmaceuticals"
}
]
}
},
{
"url": "changeDate",
"valueDate": "2024-01-01"
}
],
"url": "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
},
{
"extension": [
{
"url": "value",
"valueMoney": {
"value": 3347.1,
"currency": "CHF"
}
},
{
"url": "type",
"valueCodeableConcept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type",
"code": "756002005001",
"display": "Retail price"
}
]
}
},
{
"url": "changeType",
"valueCodeableConcept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change",
"code": "756002006005",
"display": "VAT-change"
}
]
}
},
{
"url": "changeDate",
"valueDate": "2024-01-01"
}
],
"url": "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
}
],
"url": "http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL"
}
],
"subject": [
{
"reference": "PackagedProductDefinition/PMP-Cuprior-150mg-Filmcoatedtablet"
}
],
"type": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type",
"code": "756000002003",
"display": "Reimbursement SL"
}
]
},
"indication": [
{
"extension": [
{
"extension": [
{
"url": "status",
"valueCodeableConcept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus",
"code": "756002071001",
"display": "Limitation Reimbursed"
}
]
}
},
{
"url": "statusDate",
"valueDate": "2021-08-01"
},
{
"url": "period",
"valuePeriod": {
"start": "2021-08-01"
}
},
{
"url": "firstLimitationDate",
"valueDate": "2021-08-01"
},
{
"url": "limitationText",
"valueString": "CUPRIOR wird vergütet zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter, die eine Behandlung mit D-Penicillamin nicht vertragen. Die Behandlung muss von Gastroenterologen oder Hepatologen mit Erfahrung bei der Behandlung von Patienten mit Morbus Wilson initiiert und überwacht werden."
},
{
"url": "indicationCode",
"valueString": "ABCDE.XX"
},
{
"url": "limitationIndication",
"valueReference": {
"reference": "ClinicalUseDefinition/LIM-79886009"
}
},
{
"extension": [
{
"url": "value",
"valueMoney": {
"value": 3022.1,
"currency": "CHF"
}
},
{
"url": "type",
"valueCodeableConcept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type",
"code": "756002005002",
"display": "Ex-factory price"
}
]
}
},
{
"url": "changeType",
"valueCodeableConcept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change",
"code": "756002006007",
"display": "Price mutation after triennal review of pharmaceuticals"
}
]
}
},
{
"url": "changeDate",
"valueDate": "2024-01-01"
}
],
"url": "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
},
{
"extension": [
{
"url": "value",
"valueMoney": {
"value": 3347.1,
"currency": "CHF"
}
},
{
"url": "type",
"valueCodeableConcept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type",
"code": "756002005001",
"display": "Retail price"
}
]
}
},
{
"url": "changeType",
"valueCodeableConcept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change",
"code": "756002006005",
"display": "VAT-change"
}
]
}
},
{
"url": "changeDate",
"valueDate": "2024-01-01"
}
],
"url": "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
}
],
"url": "http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation"
}
],
"reference": {
"reference": "ClinicalUseDefinition/IND-10061091"
}
}
],
"holder": {
"reference": "#holder-Curatis-AG"
}
}
},
{
"fullUrl": "http://fhir.epl.bag.admin.ch/CHIDMPManufacturedItemDefinition/MI-Trientinum-150mg-Filmcoatedtablet",
"resource": {
"resourceType": "ManufacturedItemDefinition",
"id": "MI-Trientinum-150mg-Filmcoatedtablet",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ManufacturedItemDefinition_MI-Trientinum-150mg-Filmcoatedtablet\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition MI-Trientinum-150mg-Filmcoatedtablet</b></p><a name=\"MI-Trientinum-150mg-Filmcoatedtablet\"> </a><a name=\"hcMI-Trientinum-150mg-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\">CH IDMP 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.epl.bag.admin.ch/CHIDMPAdministrableProductDefinition/PhP-Trientinum-150mg-Filmcoatedtablet",
"resource": {
"resourceType": "AdministrableProductDefinition",
"id": "PhP-Trientinum-150mg-Filmcoatedtablet",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-administrableproductdefinition"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"AdministrableProductDefinition_PhP-Trientinum-150mg-Filmcoatedtablet\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition PhP-Trientinum-150mg-Filmcoatedtablet</b></p><a name=\"PhP-Trientinum-150mg-Filmcoatedtablet\"> </a><a name=\"hcPhP-Trientinum-150mg-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\">CH IDMP AdministrableProductDefinition</a></p></div><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"MedicinalProductDefinition-Cuprior-150mg-Filmcoatedtablet.html\">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-7640109110007-6771901; indication = Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia</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/Cuprior-150mg-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.epl.bag.admin.ch/CHIDMPIngredient/Trientinum150",
"resource": {
"resourceType": "Ingredient",
"id": "Trientinum150",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_Trientinum150\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient Trientinum150</b></p><a name=\"Trientinum150\"> </a><a name=\"hcTrientinum150\"> </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\">IDMP Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Trientinum-150mg-Filmcoatedtablet.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href=\"ManufacturedItemDefinition-MI-Trientinum-150mg-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-epl/CodeSystem/ch-SMC-ingredient-role 756005051001}\">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-epl/CodeSystem/ch-SMC-substance SJ76Y07H5F}\">Trientine</span></td></tr></table><h3>Strengths</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Presentation[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>150 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span>/1 Tablet<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code15054000 = 'Tablet')</span></td></tr></table></blockquote></div>"
},
"status": "active",
"for": [
{
"reference": "AdministrableProductDefinition/PhP-Trientinum-150mg-Filmcoatedtablet"
},
{
"reference": "ManufacturedItemDefinition/MI-Trientinum-150mg-Filmcoatedtablet"
}
],
"role": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role",
"code": "756005051001",
"display": "Active"
}
]
},
"substance": {
"code": {
"concept": {
"coding": [
{
"system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-substance",
"code": "SJ76Y07H5F",
"display": "Trientine"
}
]
}
},
"strength": [
{
"presentationRatio": {
"numerator": {
"value": 150,
"unit": "mg",
"system": "http://unitsofmeasure.org",
"code": "mg"
},
"denominator": {
"value": 1,
"unit": "Tablet",
"system": "http://standardterms.edqm.eu",
"code": "15054000"
}
}
}
]
}
}
},
{
"fullUrl": "http://fhir.epl.bag.admin.ch/CHIDMPClinicalUseDefinition/IND-10061091",
"resource": {
"resourceType": "ClinicalUseDefinition",
"id": "IND-10061091",
"meta": {
"profile": [
"http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_IND-10061091\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10061091</b></p><a name=\"IND-10061091\"> </a><a name=\"hcIND-10061091\"> </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\">CH IDMP ClinicalUseDefinition Indication</a></p></div><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Cuprior-150mg-Filmcoatedtablet.html\">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-7640109110007-6771901; indication = Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia</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 10061091}\">Wilson's disease</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 200000003194}\">therapeutic</span></td></tr></table></blockquote></div>"
},
"type": "indication",
"subject": [
{
"reference": "MedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet"
}
],
"indication": {
"diseaseSymptomProcedure": {
"concept": {
"coding": [
{
"system": "https://www.meddra.org",
"code": "10061091",
"display": "Wilson's disease"
}
]
}
},
"intendedEffect": {
"concept": {
"coding": [
{
"system": "http://spor.ema.europa.eu/v1/lists/200000003186",
"code": "200000003194",
"display": "therapeutic"
}
]
}
}
}
}
},
{
"fullUrl": "http://fhir.epl.bag.admin.ch/CHIDMPClinicalUseDefinition/LIM-79886009",
"resource": {
"resourceType": "ClinicalUseDefinition",
"id": "LIM-79886009",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_LIM-79886009\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition LIM-79886009</b></p><a name=\"LIM-79886009\"> </a><a name=\"hcLIM-79886009\"> </a><p><b>type</b>: Indication</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:{http://snomed.info/sct 79886009}\">Disorder of copper metabolism</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 200000003194}\">therapeutic</span></td></tr></table></blockquote></div>"
},
"type": "indication",
"indication": {
"diseaseSymptomProcedure": {
"concept": {
"coding": [
{
"system": "http://snomed.info/sct",
"code": "79886009",
"display": "Disorder of copper metabolism"
}
]
}
},
"intendedEffect": {
"concept": {
"coding": [
{
"system": "http://spor.ema.europa.eu/v1/lists/200000003186",
"code": "200000003194",
"display": "therapeutic"
}
]
}
}
}
}
}
]
}