CH EPL (R5)
0.1.0 - ci-build
CH EPL (R5)
0.1.0 - ci-build
CH EPL (R5), published by Federal Office of Public Health FOPH. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/bag-epl/bag-epl-fhir/ and changes regularly. See the Directory of published versions
{
"resourceType" : "Bundle",
"id" : "b2eb19be-cca4-4fd8-a2a3-84d05631e6c0",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle"
]
},
"type" : "collection",
"entry" : [
{
"fullUrl" : "http://example.org/MedicinalProductDefinition/Keytruda-100mg-Vial",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "Keytruda-100mg-Vial",
"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_Keytruda-100mg-Vial\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition Keytruda-100mg-Vial</b></p><a name=\"Keytruda-100mg-Vial\"> </a><a name=\"hcKeytruda-100mg-Vial\"> </a><a name=\"Keytruda-100mg-Vial-en-US\"> </a><p><b>CH - SMC Authorized Dose Form</b>: <span title=\"Codes:{urn:oid:0.4.0.127.0.16.1.1.2.1 11213000}\">Concentrate for solution for infusion</span></p><p><b>CH - EPL Full Limitation Text</b>: Lokal rezidiverendes, nicht resezierbares oder metastasiertes triple-negatives Mammakarzinom (in Kombination mit Chemotherapie) KN 355\n(mit Preismodell). KEYTRUDA in Kombination mit Chemotherapie zur Behandlung des lokal rezidivierenden, nicht resezierbaren oder metastasierten triple-negativen Mammakarzinoms bei Erwachsenen, deren Tumore PD-L1 mit einem CPS ≥10 exprimieren und die keine vorherige Chemotherapie bei metastasierter Erkrankung erhalten haben.\n- Falls Patienten vorhergehend systemisch im (neo)adjuvanten Setting behandelt wurden: Mit Vortherapie auf Antrazyklin-Basis, ausser diese war kontraindiziert.\n- Ohne Therapie mit Checkpoint-Inhibitoren innerhalb der letzten 12 Monate.\nFolgender Code ist an den Krankenversicherer zu übermitteln: 20416.17</p><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID</code>/CH-7601001001138-6623101</p><p><b>domain</b>: <span title=\"Codes:{urn:oid:1.2.276.0.76 100000000012}\">Human</span></p><p><b>indication</b>: </p><div><p>xxxxxxx</p>\n</div><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply 756005022001}\">One-time dispensation on medical or veterinary prescription (A)</span></p><p><b>classification</b>: <span title=\"Codes:{http://www.whocc.no/atc G03FA01}\">norethisterone and estrogen</span>, <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode BT}\">Biotechnologika</span></p><p><b>attachedDocument</b>: <a href=\"DocumentReference-DocRef-FI-Keytruda.html\">DocumentReference: status = current; type = Fachinformation</a></p><blockquote><p><b>name</b></p><p><b>productName</b>: KEYTRUDA Inf Konz 100 mg/4ml</p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-medicinal-product-name-type SMC}\">Swissmedic</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" : "urn:oid:0.4.0.127.0.16.1.1.2.1",
"code" : "11213000",
"display" : "Concentrate for solution for infusion"
}
]
}
},
{
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/fullLimitationText",
"valueString" : "Lokal rezidiverendes, nicht resezierbares oder metastasiertes triple-negatives Mammakarzinom (in Kombination mit Chemotherapie) KN 355\n(mit Preismodell). KEYTRUDA in Kombination mit Chemotherapie zur Behandlung des lokal rezidivierenden, nicht resezierbaren oder metastasierten triple-negativen Mammakarzinoms bei Erwachsenen, deren Tumore PD-L1 mit einem CPS ≥10 exprimieren und die keine vorherige Chemotherapie bei metastasierter Erkrankung erhalten haben.\n- Falls Patienten vorhergehend systemisch im (neo)adjuvanten Setting behandelt wurden: Mit Vortherapie auf Antrazyklin-Basis, ausser diese war kontraindiziert.\n- Ohne Therapie mit Checkpoint-Inhibitoren innerhalb der letzten 12 Monate.\nFolgender Code ist an den Krankenversicherer zu übermitteln: 20416.17"
}
],
"identifier" : [
{
"system" : "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID",
"value" : "CH-7601001001138-6623101"
}
],
"domain" : {
"coding" : [
{
"system" : "urn:oid:1.2.276.0.76",
"code" : "100000000012",
"display" : "Human"
}
]
},
"indication" : "xxxxxxx",
"legalStatusOfSupply" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply",
"code" : "756005022001",
"display" : "One-time dispensation on medical or veterinary prescription (A)"
}
]
},
"classification" : [
{
"coding" : [
{
"system" : "http://www.whocc.no/atc",
"code" : "G03FA01"
}
]
},
{
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode",
"code" : "BT",
"display" : "Biotechnologika"
}
]
}
],
"attachedDocument" : [
{
🔗 "reference" : "DocumentReference/DocRef-FI-Keytruda"
}
],
"name" : [
{
"productName" : "KEYTRUDA Inf Konz 100 mg/4ml",
"type" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-medicinal-product-name-type",
"code" : "SMC",
"display" : "Swissmedic"
}
]
},
"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://example.org/DocumentReference/DocRef-FI-Keytruda",
"resource" : {
"resourceType" : "DocumentReference",
"id" : "DocRef-FI-Keytruda",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"DocumentReference_DocRef-FI-Keytruda\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference DocRef-FI-Keytruda</b></p><a name=\"DocRef-FI-Keytruda\"> </a><a name=\"hcDocRef-FI-Keytruda\"> </a><a name=\"DocRef-FI-Keytruda-en-US\"> </a><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 FI}\">Fachinformation</span></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/showTextAccepted.aspx?textType=FI&lang=DE&authNr=66231&supportMultipleResults=1\">https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=66231&supportMultipleResults=1</a></td></tr></table></blockquote></div>"
},
"status" : "current",
"type" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type",
"code" : "FI",
"display" : "Fachinformation"
}
]
},
"content" : [
{
"attachment" : {
"url" : "https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=66231&supportMultipleResults=1"
}
}
]
}
},
{
"fullUrl" : "http://example.org/RegulatedAuthorisation/MA-6623101",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "MA-6623101",
"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-6623101\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-6623101</b></p><a name=\"MA-6623101\"> </a><a name=\"hcMA-6623101\"> </a><a name=\"MA-6623101-en-US\"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/6623101</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Keytruda-100mg-Vial.html\">MedicinalProductDefinition: extension = Concentrate for solution for infusion,Lokal rezidiverendes, nicht resezierbares oder metastasiertes triple-negatives Mammakarzinom (in Kombination mit Chemotherapie) KN 355\n(mit Preismodell). KEYTRUDA in Kombination mit Chemotherapie zur Behandlung des lokal rezidivierenden, nicht resezierbaren oder metastasierten triple-negativen Mammakarzinoms bei Erwachsenen, deren Tumore PD-L1 mit einem CPS ≥10 exprimieren und die keine vorherige Chemotherapie bei metastasierter Erkrankung erhalten haben.\n- Falls Patienten vorhergehend systemisch im (neo)adjuvanten Setting behandelt wurden: Mit Vortherapie auf Antrazyklin-Basis, ausser diese war kontraindiziert.\n- Ohne Therapie mit Checkpoint-Inhibitoren innerhalb der letzten 12 Monate.\nFolgender Code ist an den Krankenversicherer zu übermitteln: 20416.17; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001001138-6623101; domain = Human; indication = xxxxxxx; legalStatusOfSupply = One-time dispensation on medical or veterinary prescription (A); classification = norethisterone and estrogen,Biotechnologika</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 Z}\">zugelassen</span></p><p><b>statusDate</b>: 2022-02-17</p><p><b>holder</b>: <a href=\"#hcMA-6623101/holder-MSD-Merck-Sharp-Dohme-AG\">Organization MSD Merck Sharp & Dohme AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-6623101/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-MSD-Merck-Sharp-Dohme-AG</b></p><a name=\"MA-6623101/holder-MSD-Merck-Sharp-Dohme-AG\"> </a><a name=\"hcMA-6623101/holder-MSD-Merck-Sharp-Dohme-AG\"> </a><a name=\"MA-6623101/holder-MSD-Merck-Sharp-Dohme-AG-en-US\"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100080484, <a href=\"https://www.gs1.org/standards/id-keys/gln\" title=\"Global Location Number\">GLN</a>/7601001001138</p><p><b>name</b>: MSD Merck Sharp & Dohme AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name=\"MA-6623101/regulator-SMC\"> </a><a name=\"hcMA-6623101/regulator-SMC\"> </a><a name=\"MA-6623101/regulator-SMC-en-US\"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100010911, <a href=\"https://www.gs1.org/standards/id-keys/gln\" title=\"Global Location Number\">GLN</a>/7601001398511</p><p><b>name</b>: SMC</p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Organization",
"id" : "holder-MSD-Merck-Sharp-Dohme-AG",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier" : [
{
"system" : "urn:oid:1.2.276.0.76",
"value" : "100080484"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001001138"
}
],
"name" : "MSD Merck Sharp & Dohme AG"
},
{
"resourceType" : "Organization",
"id" : "regulator-SMC",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier" : [
{
"system" : "urn:oid:1.2.276.0.76",
"value" : "100010911"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001398511"
}
],
"name" : "SMC"
}
],
"identifier" : [
{
"system" : "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber",
"value" : "6623101"
}
],
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Keytruda-100mg-Vial"
}
],
"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" : "Z",
"display" : "zugelassen"
}
]
},
"statusDate" : "2022-02-17",
"holder" : {
"reference" : "#holder-MSD-Merck-Sharp-Dohme-AG"
},
"regulator" : {
"reference" : "#regulator-SMC"
}
}
},
{
"fullUrl" : "http://example.org/PackagedProductDefinition/PMP-Keytruda-100mg-4ml-Solution-for-Infusion",
"resource" : {
"resourceType" : "PackagedProductDefinition",
"id" : "PMP-Keytruda-100mg-4ml-Solution-for-Infusion",
"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-Keytruda-100mg-4ml-Solution-for-Infusion\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition PMP-Keytruda-100mg-4ml-Solution-for-Infusion</b></p><a name=\"PMP-Keytruda-100mg-4ml-Solution-for-Infusion\"> </a><a name=\"hcPMP-Keytruda-100mg-4ml-Solution-for-Infusion\"> </a><a name=\"PMP-Keytruda-100mg-4ml-Solution-for-Infusion-en-US\"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID</code>/CH-7601001001138-6623101-001</p><p><b>packageFor</b>: <a href=\"MedicinalProductDefinition-Keytruda-100mg-Vial.html\">MedicinalProductDefinition: extension = Concentrate for solution for infusion,Lokal rezidiverendes, nicht resezierbares oder metastasiertes triple-negatives Mammakarzinom (in Kombination mit Chemotherapie) KN 355\n(mit Preismodell). KEYTRUDA in Kombination mit Chemotherapie zur Behandlung des lokal rezidivierenden, nicht resezierbaren oder metastasierten triple-negativen Mammakarzinoms bei Erwachsenen, deren Tumore PD-L1 mit einem CPS ≥10 exprimieren und die keine vorherige Chemotherapie bei metastasierter Erkrankung erhalten haben.\n- Falls Patienten vorhergehend systemisch im (neo)adjuvanten Setting behandelt wurden: Mit Vortherapie auf Antrazyklin-Basis, ausser diese war kontraindiziert.\n- Ohne Therapie mit Checkpoint-Inhibitoren innerhalb der letzten 12 Monate.\nFolgender Code ist an den Krankenversicherer zu übermitteln: 20416.17; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001001138-6623101; domain = Human; indication = xxxxxxx; legalStatusOfSupply = One-time dispensation on medical or veterinary prescription (A); classification = norethisterone and estrogen,Biotechnologika</a></p><p><b>description</b>: </p><div><p>KEYTRUDA Inf Konz 100 mg/4ml Durchstf</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 756005022001}\">One-time dispensation on medical or veterinary prescription (A)</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <code>urn:oid:2.51.1.1</code>/7680662310018</p><p><b>type</b>: <span title=\"Codes:{urn:oid:0.4.0.127.0.16.1.1.2.1 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>SpecialPrecautionsForStorage</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:oid:1.2.276.0.76 100000073403}\">Shelf life of the medicinal product as packaged for sale</span></td><td><span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage 2}\">Im Kühlschrank (2°C - 8°C)</span></td></tr><tr><td style=\"display: none\">*</td><td> </td><td><span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage L}\">vor Licht Schützen</span></td></tr><tr><td style=\"display: none\">*</td><td> </td><td><span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage NF}\">Nicht einfrieren</span></td></tr><tr><td style=\"display: none\">*</td><td> </td><td><span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage OVP}\">In der Originalverpackung aufbewahren.</span></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID",
"value" : "CH-7601001001138-6623101-001"
}
],
"packageFor" : [
{
🔗 "reference" : "MedicinalProductDefinition/Keytruda-100mg-Vial"
}
],
"description" : "KEYTRUDA Inf Konz 100 mg/4ml Durchstf",
"legalStatusOfSupply" : [
{
"code" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply",
"code" : "756005022001",
"display" : "One-time dispensation on medical or veterinary prescription (A)"
}
]
}
}
],
"packaging" : {
"identifier" : [
{
"system" : "urn:oid:2.51.1.1",
"value" : "7680662310018"
}
],
"type" : {
"coding" : [
{
"system" : "urn:oid:0.4.0.127.0.16.1.1.2.1",
"code" : "30009000",
"display" : "Box"
}
]
},
"quantity" : 1,
"shelfLifeStorage" : [
{
"type" : {
"coding" : [
{
"system" : "urn:oid:1.2.276.0.76",
"code" : "100000073403",
"display" : "Shelf life of the medicinal product as packaged for sale"
}
]
},
"specialPrecautionsForStorage" : [
{
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage",
"code" : "2",
"display" : "Im Kühlschrank (2°C - 8°C)"
}
]
}
]
},
{
"specialPrecautionsForStorage" : [
{
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage",
"code" : "L",
"display" : "vor Licht Schützen"
}
]
}
]
},
{
"specialPrecautionsForStorage" : [
{
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage",
"code" : "NF",
"display" : "Nicht einfrieren"
}
]
}
]
},
{
"specialPrecautionsForStorage" : [
{
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage",
"code" : "OVP",
"display" : "In der Originalverpackung aufbewahren."
}
]
}
]
}
]
}
}
},
{
"fullUrl" : "http://example.org/RegulatedAuthorisation/MA-66231001",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "MA-66231001",
"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-66231001\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-66231001</b></p><a name=\"MA-66231001\"> </a><a name=\"hcMA-66231001\"> </a><a name=\"MA-66231001-en-US\"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/66231001</p><p><b>subject</b>: <a href=\"PackagedProductDefinition-PMP-Keytruda-100mg-4ml-Solution-for-Infusion.html\">PackagedProductDefinition: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID#CH-7601001001138-6623101-001; description = KEYTRUDA Inf Konz 100 mg/4ml Durchstf</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 Z}\">zugelassen</span></p><p><b>statusDate</b>: 2022-02-17</p><p><b>holder</b>: <a href=\"#hcMA-66231001/holder-MSD-Merck-Sharp-Dohme-AG\">Organization MSD Merck Sharp & Dohme AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-66231001/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-MSD-Merck-Sharp-Dohme-AG</b></p><a name=\"MA-66231001/holder-MSD-Merck-Sharp-Dohme-AG\"> </a><a name=\"hcMA-66231001/holder-MSD-Merck-Sharp-Dohme-AG\"> </a><a name=\"MA-66231001/holder-MSD-Merck-Sharp-Dohme-AG-en-US\"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100080484, <a href=\"https://www.gs1.org/standards/id-keys/gln\" title=\"Global Location Number\">GLN</a>/7601001001138</p><p><b>name</b>: MSD Merck Sharp & Dohme AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name=\"MA-66231001/regulator-SMC\"> </a><a name=\"hcMA-66231001/regulator-SMC\"> </a><a name=\"MA-66231001/regulator-SMC-en-US\"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100010911, <a href=\"https://www.gs1.org/standards/id-keys/gln\" title=\"Global Location Number\">GLN</a>/7601001398511</p><p><b>name</b>: SMC</p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Organization",
"id" : "holder-MSD-Merck-Sharp-Dohme-AG",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier" : [
{
"system" : "urn:oid:1.2.276.0.76",
"value" : "100080484"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001001138"
}
],
"name" : "MSD Merck Sharp & Dohme AG"
},
{
"resourceType" : "Organization",
"id" : "regulator-SMC",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier" : [
{
"system" : "urn:oid:1.2.276.0.76",
"value" : "100010911"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001398511"
}
],
"name" : "SMC"
}
],
"identifier" : [
{
"system" : "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber",
"value" : "66231001"
}
],
"subject" : [
{
🔗 "reference" : "PackagedProductDefinition/PMP-Keytruda-100mg-4ml-Solution-for-Infusion"
}
],
"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" : "Z",
"display" : "zugelassen"
}
]
},
"statusDate" : "2022-02-17",
"holder" : {
"reference" : "#holder-MSD-Merck-Sharp-Dohme-AG"
},
"regulator" : {
"reference" : "#regulator-SMC"
}
}
},
{
"fullUrl" : "http://example.org/RegulatedAuthorisation/FOPH-20416",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "FOPH-20416",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_FOPH-20416\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization FOPH-20416</b></p><a name=\"FOPH-20416\"> </a><a name=\"hcFOPH-20416\"> </a><a name=\"FOPH-20416-en-US\"> </a><blockquote><p><b>CH - EPL Reimbursement SL</b></p><ul><li>FOPHDossierNumber: <code>urn:oid:2.16.756.1</code>/20416</li><li>status: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status 756001021001}\">Reimbursed</span></li><li>statusDate: 2023-01-01</li><li>expiryDate: 2025-03-31</li><li>listingStatus: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status 756001002001}\">Listed</span></li><li>listingPeriod: 2023-01-01 --> 2024-12-31</li><li>firstListingDate: 2017-09-01</li><li>costShare: 10</li><li>gamme: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme 756002004009}\">Parenteral Depot</span></li></ul></blockquote><blockquote><p><b>CH - EPL Product Price</b></p><ul><li>value: <span title=\"Swiss Franc\">CHF4,407.68</span> (CHF)</li><li>type: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type 756002005002}\">Ex-factory price</span></li><li>changeType: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change 756002006006}\">Normal price mutation</span></li><li>changeDate: 2023-01-01</li></ul></blockquote><blockquote><p><b>CH - EPL Product Price</b></p><ul><li>value: <span title=\"Swiss Franc\">CHF4,768.50</span> (CHF)</li><li>type: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type 756002005001}\">Retail price</span></li><li>changeType: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change 756002006005}\">VAT-change</span></li><li>changeDate: 2024-01-01</li></ul></blockquote><p><b>subject</b>: <a href=\"PackagedProductDefinition-PMP-Keytruda-100mg-4ml-Solution-for-Infusion.html\">PackagedProductDefinition: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID#CH-7601001001138-6623101-001; description = KEYTRUDA Inf Konz 100 mg/4ml Durchstf</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-10075566.html\">ClinicalUseDefinition: type = indication</a></td></tr></table><p><b>holder</b>: <a href=\"#hcFOPH-20416/holder-MSD-Merck-Sharp-Dohme-AG\">Organization MSD Merck Sharp & Dohme AG</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-MSD-Merck-Sharp-Dohme-AG</b></p><a name=\"FOPH-20416/holder-MSD-Merck-Sharp-Dohme-AG\"> </a><a name=\"hcFOPH-20416/holder-MSD-Merck-Sharp-Dohme-AG\"> </a><a name=\"FOPH-20416/holder-MSD-Merck-Sharp-Dohme-AG-en-US\"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100080484, <a href=\"https://www.gs1.org/standards/id-keys/gln\" title=\"Global Location Number\">GLN</a>/7601001001138</p><p><b>name</b>: MSD Merck Sharp & Dohme AG</p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Organization",
"id" : "holder-MSD-Merck-Sharp-Dohme-AG",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier" : [
{
"system" : "urn:oid:1.2.276.0.76",
"value" : "100080484"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001001138"
}
],
"name" : "MSD Merck Sharp & Dohme AG"
}
],
"extension" : [
{
"extension" : [
{
"url" : "FOPHDossierNumber",
"valueIdentifier" : {
"system" : "urn:oid:2.16.756.1",
"value" : "20416"
}
},
{
"url" : "status",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status",
"code" : "756001021001",
"display" : "Reimbursed"
}
]
}
},
{
"url" : "statusDate",
"valueDate" : "2023-01-01"
},
{
"url" : "expiryDate",
"valueDate" : "2025-03-31"
},
{
"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" : "2023-01-01",
"end" : "2024-12-31"
}
},
{
"url" : "firstListingDate",
"valueDate" : "2017-09-01"
},
{
"url" : "costShare",
"valueInteger" : 10
},
{
"url" : "gamme",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme",
"code" : "756002004009",
"display" : "Parenteral Depot"
}
]
}
}
],
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL"
},
{
"extension" : [
{
"url" : "value",
"valueMoney" : {
"value" : 4407.68,
"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" : "756002006006",
"display" : "Normal price mutation"
}
]
}
},
{
"url" : "changeDate",
"valueDate" : "2023-01-01"
}
],
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
},
{
"extension" : [
{
"url" : "value",
"valueMoney" : {
"value" : 4768.5,
"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"
}
],
"subject" : [
{
🔗 "reference" : "PackagedProductDefinition/PMP-Keytruda-100mg-4ml-Solution-for-Infusion"
}
],
"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" : "2023-01-01"
},
{
"url" : "period",
"valuePeriod" : {
"start" : "2023-01-01",
"end" : "2024-12-31"
}
},
{
"url" : "reimbursementEndDate",
"valueDate" : "2025-03-31"
},
{
"url" : "firstLimitationDate",
"valueDate" : "2023-01-01"
},
{
"url" : "indicationCode",
"valueString" : "20416.17"
},
{
"url" : "limitationIndication",
"valueReference" : {
🔗 "reference" : "ClinicalUseDefinition/LIM-254837009"
}
},
{
"extension" : [
{
"url" : "value",
"valueMoney" : {
"value" : 4407.68,
"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" : "756002006006",
"display" : "Normal price mutation"
}
]
}
},
{
"url" : "changeDate",
"valueDate" : "2023-01-01"
}
],
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
},
{
"extension" : [
{
"url" : "value",
"valueMoney" : {
"value" : 4768.5,
"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-10075566"
}
}
],
"holder" : {
"reference" : "#holder-MSD-Merck-Sharp-Dohme-AG"
}
}
},
{
"fullUrl" : "http://example.org/ManufacturedItemDefinition/MI-Pembrolizumab-100mg-Vial",
"resource" : {
"resourceType" : "ManufacturedItemDefinition",
"id" : "MI-Pembrolizumab-100mg-Vial",
"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-Pembrolizumab-100mg-Vial\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition MI-Pembrolizumab-100mg-Vial</b></p><a name=\"MI-Pembrolizumab-100mg-Vial\"> </a><a name=\"hcMI-Pembrolizumab-100mg-Vial\"> </a><a name=\"MI-Pembrolizumab-100mg-Vial-en-US\"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{urn:oid:0.4.0.127.0.16.1.1.2.1 10221000}\">Film-coated tablet</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{urn:oid:0.4.0.127.0.16.1.1.2.1 15060000}\">Vial</span></p></div>"
},
"status" : "active",
"manufacturedDoseForm" : {
"coding" : [
{
"system" : "urn:oid:0.4.0.127.0.16.1.1.2.1",
"code" : "10221000",
"display" : "Film-coated tablet"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "urn:oid:0.4.0.127.0.16.1.1.2.1",
"code" : "15060000",
"display" : "Vial"
}
]
}
}
},
{
"fullUrl" : "http://example.org/AdministrableProductDefinition/PhP-Pembrolizumab-100mg-Vial",
"resource" : {
"resourceType" : "AdministrableProductDefinition",
"id" : "PhP-Pembrolizumab-100mg-Vial",
"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-Pembrolizumab-100mg-Vial\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition PhP-Pembrolizumab-100mg-Vial</b></p><a name=\"PhP-Pembrolizumab-100mg-Vial\"> </a><a name=\"hcPhP-Pembrolizumab-100mg-Vial\"> </a><a name=\"PhP-Pembrolizumab-100mg-Vial-en-US\"> </a><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"MedicinalProductDefinition-Keytruda-100mg-Vial.html\">MedicinalProductDefinition: extension = Concentrate for solution for infusion,Lokal rezidiverendes, nicht resezierbares oder metastasiertes triple-negatives Mammakarzinom (in Kombination mit Chemotherapie) KN 355\n(mit Preismodell). KEYTRUDA in Kombination mit Chemotherapie zur Behandlung des lokal rezidivierenden, nicht resezierbaren oder metastasierten triple-negativen Mammakarzinoms bei Erwachsenen, deren Tumore PD-L1 mit einem CPS ≥10 exprimieren und die keine vorherige Chemotherapie bei metastasierter Erkrankung erhalten haben.\n- Falls Patienten vorhergehend systemisch im (neo)adjuvanten Setting behandelt wurden: Mit Vortherapie auf Antrazyklin-Basis, ausser diese war kontraindiziert.\n- Ohne Therapie mit Checkpoint-Inhibitoren innerhalb der letzten 12 Monate.\nFolgender Code ist an den Krankenversicherer zu übermitteln: 20416.17; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001001138-6623101; domain = Human; indication = xxxxxxx; legalStatusOfSupply = One-time dispensation on medical or veterinary prescription (A); classification = norethisterone and estrogen,Biotechnologika</a></p><p><b>administrableDoseForm</b>: <span title=\"Codes:{urn:oid:0.4.0.127.0.16.1.1.2.1 11210000}\">Solution for infusion</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{urn:oid:0.4.0.127.0.16.1.1.2.1 15060000}\">Vial</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:{urn:oid:0.4.0.127.0.16.1.1.2.1 20045000}\">Intravenous use</span></td></tr></table></div>"
},
"status" : "active",
"formOf" : [
{
🔗 "reference" : "MedicinalProductDefinition/Keytruda-100mg-Vial"
}
],
"administrableDoseForm" : {
"coding" : [
{
"system" : "urn:oid:0.4.0.127.0.16.1.1.2.1",
"code" : "11210000",
"display" : "Solution for infusion"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "urn:oid:0.4.0.127.0.16.1.1.2.1",
"code" : "15060000",
"display" : "Vial"
}
]
},
"routeOfAdministration" : [
{
"code" : {
"coding" : [
{
"system" : "urn:oid:0.4.0.127.0.16.1.1.2.1",
"code" : "20045000",
"display" : "Intravenous use"
}
]
}
}
]
}
},
{
"fullUrl" : "http://example.org/Ingredient/Pembrolizumab100",
"resource" : {
"resourceType" : "Ingredient",
"id" : "Pembrolizumab100",
"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_Pembrolizumab100\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient Pembrolizumab100</b></p><a name=\"Pembrolizumab100\"> </a><a name=\"hcPembrolizumab100\"> </a><a name=\"Pembrolizumab100-en-US\"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Pembrolizumab-100mg-Vial.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for infusion; unitOfPresentation = Vial</a></li><li><a href=\"ManufacturedItemDefinition-MI-Pembrolizumab-100mg-Vial.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Vial</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role WIRKS}\">Wirkstoff</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 DPT0O3T46P}\">Pembrolizumab</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>100 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span>/1 Vial<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code15060000 = 'Vial')</span></td></tr></table></blockquote></div>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "AdministrableProductDefinition/PhP-Pembrolizumab-100mg-Vial"
},
{
🔗 "reference" : "ManufacturedItemDefinition/MI-Pembrolizumab-100mg-Vial"
}
],
"role" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role",
"code" : "WIRKS",
"display" : "Wirkstoff"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-substance",
"code" : "DPT0O3T46P",
"display" : "Pembrolizumab"
}
]
}
},
"strength" : [
{
"presentationRatio" : {
"numerator" : {
"value" : 100,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
},
"denominator" : {
"value" : 1,
"unit" : "Vial",
"system" : "urn:oid:0.4.0.127.0.16.1.1.2.1",
"code" : "15060000"
}
}
}
]
}
}
},
{
"fullUrl" : "http://example.org/ClinicalUseDefinition/IND-10027400",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "IND-10027400",
"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-10027400\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10027400</b></p><a name=\"IND-10027400\"> </a><a name=\"hcIND-10027400\"> </a><a name=\"IND-10027400-en-US\"> </a><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Keytruda-100mg-Vial.html\">MedicinalProductDefinition: extension = Concentrate for solution for infusion,Lokal rezidiverendes, nicht resezierbares oder metastasiertes triple-negatives Mammakarzinom (in Kombination mit Chemotherapie) KN 355\n(mit Preismodell). KEYTRUDA in Kombination mit Chemotherapie zur Behandlung des lokal rezidivierenden, nicht resezierbaren oder metastasierten triple-negativen Mammakarzinoms bei Erwachsenen, deren Tumore PD-L1 mit einem CPS ≥10 exprimieren und die keine vorherige Chemotherapie bei metastasierter Erkrankung erhalten haben.\n- Falls Patienten vorhergehend systemisch im (neo)adjuvanten Setting behandelt wurden: Mit Vortherapie auf Antrazyklin-Basis, ausser diese war kontraindiziert.\n- Ohne Therapie mit Checkpoint-Inhibitoren innerhalb der letzten 12 Monate.\nFolgender Code ist an den Krankenversicherer zu übermitteln: 20416.17; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001001138-6623101; domain = Human; indication = xxxxxxx; legalStatusOfSupply = One-time dispensation on medical or veterinary prescription (A); classification = norethisterone and estrogen,Biotechnologika</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 10027400}\">Melanom</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:{urn:oid:1.2.276.0.76 200000003194}\">therapeutic</span></td></tr></table></blockquote></div>"
},
"type" : "indication",
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Keytruda-100mg-Vial"
}
],
"indication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10027400",
"display" : "Melanom"
}
]
}
},
"intendedEffect" : {
"concept" : {
"coding" : [
{
"system" : "urn:oid:1.2.276.0.76",
"code" : "200000003194",
"display" : "therapeutic"
}
]
}
}
}
}
},
{
"fullUrl" : "http://example.org/ClinicalUseDefinition/IND-10075566",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "IND-10075566",
"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-10075566\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10075566</b></p><a name=\"IND-10075566\"> </a><a name=\"hcIND-10075566\"> </a><a name=\"IND-10075566-en-US\"> </a><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Keytruda-100mg-Vial.html\">MedicinalProductDefinition: extension = Concentrate for solution for infusion,Lokal rezidiverendes, nicht resezierbares oder metastasiertes triple-negatives Mammakarzinom (in Kombination mit Chemotherapie) KN 355\n(mit Preismodell). KEYTRUDA in Kombination mit Chemotherapie zur Behandlung des lokal rezidivierenden, nicht resezierbaren oder metastasierten triple-negativen Mammakarzinoms bei Erwachsenen, deren Tumore PD-L1 mit einem CPS ≥10 exprimieren und die keine vorherige Chemotherapie bei metastasierter Erkrankung erhalten haben.\n- Falls Patienten vorhergehend systemisch im (neo)adjuvanten Setting behandelt wurden: Mit Vortherapie auf Antrazyklin-Basis, ausser diese war kontraindiziert.\n- Ohne Therapie mit Checkpoint-Inhibitoren innerhalb der letzten 12 Monate.\nFolgender Code ist an den Krankenversicherer zu übermitteln: 20416.17; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001001138-6623101; domain = Human; indication = xxxxxxx; legalStatusOfSupply = One-time dispensation on medical or veterinary prescription (A); classification = norethisterone and estrogen,Biotechnologika</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 10075566}\">Triple negative breast cancer</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:{urn:oid:1.2.276.0.76 200000003194}\">therapeutic</span></td></tr></table></blockquote></div>"
},
"type" : "indication",
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Keytruda-100mg-Vial"
}
],
"indication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10075566",
"display" : "Triple negative breast cancer"
}
]
}
},
"intendedEffect" : {
"concept" : {
"coding" : [
{
"system" : "urn:oid:1.2.276.0.76",
"code" : "200000003194",
"display" : "therapeutic"
}
]
}
}
}
}
},
{
"fullUrl" : "http://example.org/ClinicalUseDefinition/IND-10028881",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "IND-10028881",
"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-10028881\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10028881</b></p><a name=\"IND-10028881\"> </a><a name=\"hcIND-10028881\"> </a><a name=\"IND-10028881-en-US\"> </a><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Keytruda-100mg-Vial.html\">MedicinalProductDefinition: extension = Concentrate for solution for infusion,Lokal rezidiverendes, nicht resezierbares oder metastasiertes triple-negatives Mammakarzinom (in Kombination mit Chemotherapie) KN 355\n(mit Preismodell). KEYTRUDA in Kombination mit Chemotherapie zur Behandlung des lokal rezidivierenden, nicht resezierbaren oder metastasierten triple-negativen Mammakarzinoms bei Erwachsenen, deren Tumore PD-L1 mit einem CPS ≥10 exprimieren und die keine vorherige Chemotherapie bei metastasierter Erkrankung erhalten haben.\n- Falls Patienten vorhergehend systemisch im (neo)adjuvanten Setting behandelt wurden: Mit Vortherapie auf Antrazyklin-Basis, ausser diese war kontraindiziert.\n- Ohne Therapie mit Checkpoint-Inhibitoren innerhalb der letzten 12 Monate.\nFolgender Code ist an den Krankenversicherer zu übermitteln: 20416.17; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001001138-6623101; domain = Human; indication = xxxxxxx; legalStatusOfSupply = One-time dispensation on medical or veterinary prescription (A); classification = norethisterone and estrogen,Biotechnologika</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 10028881}\">Nicht-kleinzelliges Lungenkarzinom</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:{urn:oid:1.2.276.0.76 200000003194}\">therapeutic</span></td></tr></table></blockquote></div>"
},
"type" : "indication",
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Keytruda-100mg-Vial"
}
],
"indication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10028881",
"display" : "Nicht-kleinzelliges Lungenkarzinom"
}
]
}
},
"intendedEffect" : {
"concept" : {
"coding" : [
{
"system" : "urn:oid:1.2.276.0.76",
"code" : "200000003194",
"display" : "therapeutic"
}
]
}
}
}
}
},
{
"fullUrl" : "http://example.org/ClinicalUseDefinition/IND-10021782",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "IND-10021782",
"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-10021782\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10021782</b></p><a name=\"IND-10021782\"> </a><a name=\"hcIND-10021782\"> </a><a name=\"IND-10021782-en-US\"> </a><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Keytruda-100mg-Vial.html\">MedicinalProductDefinition: extension = Concentrate for solution for infusion,Lokal rezidiverendes, nicht resezierbares oder metastasiertes triple-negatives Mammakarzinom (in Kombination mit Chemotherapie) KN 355\n(mit Preismodell). KEYTRUDA in Kombination mit Chemotherapie zur Behandlung des lokal rezidivierenden, nicht resezierbaren oder metastasierten triple-negativen Mammakarzinoms bei Erwachsenen, deren Tumore PD-L1 mit einem CPS ≥10 exprimieren und die keine vorherige Chemotherapie bei metastasierter Erkrankung erhalten haben.\n- Falls Patienten vorhergehend systemisch im (neo)adjuvanten Setting behandelt wurden: Mit Vortherapie auf Antrazyklin-Basis, ausser diese war kontraindiziert.\n- Ohne Therapie mit Checkpoint-Inhibitoren innerhalb der letzten 12 Monate.\nFolgender Code ist an den Krankenversicherer zu übermitteln: 20416.17; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001001138-6623101; domain = Human; indication = xxxxxxx; legalStatusOfSupply = One-time dispensation on medical or veterinary prescription (A); classification = norethisterone and estrogen,Biotechnologika</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 10021782}\">Kopf- und Halskarzinom</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:{urn:oid:1.2.276.0.76 200000003194}\">therapeutic</span></td></tr></table></blockquote></div>"
},
"type" : "indication",
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Keytruda-100mg-Vial"
}
],
"indication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10021782",
"display" : "Kopf- und Halskarzinom"
}
]
}
},
"intendedEffect" : {
"concept" : {
"coding" : [
{
"system" : "urn:oid:1.2.276.0.76",
"code" : "200000003194",
"display" : "therapeutic"
}
]
}
}
}
}
},
{
"fullUrl" : "http://example.org/ClinicalUseDefinition/IND-10019927",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "IND-10019927",
"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-10019927\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10019927</b></p><a name=\"IND-10019927\"> </a><a name=\"hcIND-10019927\"> </a><a name=\"IND-10019927-en-US\"> </a><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Keytruda-100mg-Vial.html\">MedicinalProductDefinition: extension = Concentrate for solution for infusion,Lokal rezidiverendes, nicht resezierbares oder metastasiertes triple-negatives Mammakarzinom (in Kombination mit Chemotherapie) KN 355\n(mit Preismodell). KEYTRUDA in Kombination mit Chemotherapie zur Behandlung des lokal rezidivierenden, nicht resezierbaren oder metastasierten triple-negativen Mammakarzinoms bei Erwachsenen, deren Tumore PD-L1 mit einem CPS ≥10 exprimieren und die keine vorherige Chemotherapie bei metastasierter Erkrankung erhalten haben.\n- Falls Patienten vorhergehend systemisch im (neo)adjuvanten Setting behandelt wurden: Mit Vortherapie auf Antrazyklin-Basis, ausser diese war kontraindiziert.\n- Ohne Therapie mit Checkpoint-Inhibitoren innerhalb der letzten 12 Monate.\nFolgender Code ist an den Krankenversicherer zu übermitteln: 20416.17; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001001138-6623101; domain = Human; indication = xxxxxxx; legalStatusOfSupply = One-time dispensation on medical or veterinary prescription (A); classification = norethisterone and estrogen,Biotechnologika</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 10019927}\">Klassisches Hodgkin Lymphom</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:{urn:oid:1.2.276.0.76 200000003194}\">therapeutic</span></td></tr></table></blockquote></div>"
},
"type" : "indication",
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Keytruda-100mg-Vial"
}
],
"indication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10019927",
"display" : "Klassisches Hodgkin Lymphom"
}
]
}
},
"intendedEffect" : {
"concept" : {
"coding" : [
{
"system" : "urn:oid:1.2.276.0.76",
"code" : "200000003194",
"display" : "therapeutic"
}
]
}
}
}
}
},
{
"fullUrl" : "http://example.org/ClinicalUseDefinition/IND-10043971",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "IND-10043971",
"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-10043971\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10043971</b></p><a name=\"IND-10043971\"> </a><a name=\"hcIND-10043971\"> </a><a name=\"IND-10043971-en-US\"> </a><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Keytruda-100mg-Vial.html\">MedicinalProductDefinition: extension = Concentrate for solution for infusion,Lokal rezidiverendes, nicht resezierbares oder metastasiertes triple-negatives Mammakarzinom (in Kombination mit Chemotherapie) KN 355\n(mit Preismodell). KEYTRUDA in Kombination mit Chemotherapie zur Behandlung des lokal rezidivierenden, nicht resezierbaren oder metastasierten triple-negativen Mammakarzinoms bei Erwachsenen, deren Tumore PD-L1 mit einem CPS ≥10 exprimieren und die keine vorherige Chemotherapie bei metastasierter Erkrankung erhalten haben.\n- Falls Patienten vorhergehend systemisch im (neo)adjuvanten Setting behandelt wurden: Mit Vortherapie auf Antrazyklin-Basis, ausser diese war kontraindiziert.\n- Ohne Therapie mit Checkpoint-Inhibitoren innerhalb der letzten 12 Monate.\nFolgender Code ist an den Krankenversicherer zu übermitteln: 20416.17; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001001138-6623101; domain = Human; indication = xxxxxxx; legalStatusOfSupply = One-time dispensation on medical or veterinary prescription (A); classification = norethisterone and estrogen,Biotechnologika</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 10043971}\">Primäres mediastinales grosszelliges B-Zell-Lymphom</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:{urn:oid:1.2.276.0.76 200000003194}\">therapeutic</span></td></tr></table></blockquote></div>"
},
"type" : "indication",
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Keytruda-100mg-Vial"
}
],
"indication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10043971",
"display" : "Primäres mediastinales grosszelliges B-Zell-Lymphom"
}
]
}
},
"intendedEffect" : {
"concept" : {
"coding" : [
{
"system" : "urn:oid:1.2.276.0.76",
"code" : "200000003194",
"display" : "therapeutic"
}
]
}
}
}
}
},
{
"fullUrl" : "http://example.org/ClinicalUseDefinition/LIM-254837009",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "LIM-254837009",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_LIM-254837009\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition LIM-254837009</b></p><a name=\"LIM-254837009\"> </a><a name=\"hcLIM-254837009\"> </a><a name=\"LIM-254837009-en-US\"> </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 254837009}\">Malignant tumor of breast</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:{urn:oid:1.2.276.0.76 200000003194}\">therapeutic</span></td></tr></table></blockquote></div>"
},
"type" : "indication",
"indication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "254837009",
"display" : "Malignant tumor of breast"
}
]
}
},
"intendedEffect" : {
"concept" : {
"coding" : [
{
"system" : "urn:oid:1.2.276.0.76",
"code" : "200000003194",
"display" : "therapeutic"
}
]
}
}
}
}
}
]
}