CH EPL (R5)
1.0.0 - trial-use
CH EPL (R5)
1.0.0 - trial-use
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 1.0.0 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" : "MedicinalProductDefinition",
"id" : "Paxlovid-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\"><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition Paxlovid-Filmcoatedtablet</b></p><a name=\"Paxlovid-Filmcoatedtablet\"> </a><a name=\"hcPaxlovid-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-7601001010604-6879301</p><p><b>indication</b>: </p><div><p>Paxlovid wird angewendet für die Behandlung der Coronavirus-Krankheit 2019 (COVID-19) bei Erwachsenen, die keine Sauerstofftherapie oder Hospitalisierung aufgrund von COVID-19 benötigen und bei denen ein erhöhtes Risiko für einen schweren Verlauf von COVID-19 besteht (siehe «Klinische Wirksamkeit»).\nPaxlovid ist nicht als Ersatz für eine Impfung gegen COVID-19 vorgesehen. Paxlovid sollte gemäss den offiziellen Empfehlungen und unter Berücksichtigung der lokalen epidemiologischen Daten zu zirkulierenden SARS-CoV-2-Varianten angewendet werden.</p>\n</div><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply 756005022002}\">Medicinal product subject to medical or veterinary prescription single dispensation (A+)</span></p><p><b>additionalMonitoringIndicator</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-additional-monitoring-indicator 756005001001}\">Black Triangle Warning</span></p><p><b>pediatricUseIndicator</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-pediatric-use-indicator 756005003002}\">Not authorised for the treatment in children</span></p><p><b>classification</b>: <span title=\"Codes:{http://www.whocc.no/atc J05AE}\">Protease inhibitors</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 080000}\">08. INFEKTIONSKRANKHEITEN</span>, <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus 080300}\">08.03. Mittel gegen Viren</span></p><p><b>attachedDocument</b>: </p><ul><li><a href=\"DocumentReference-DocRef-FI-Paxlovid.html\">DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-nop-123; status = current; type = Fachinformation; date = 2024-07-01 00:00:00+0000</a></li><li><a href=\"DocumentReference-DocRef-PI-Paxlovid.html\">DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-nop-321; status = current; type = Patienteninformation; date = 2024-07-01 00:00:00+0000</a></li></ul><blockquote><p><b>name</b></p><p><b>productName</b>: PAXLOVID Filmtabl 4x150mg/2x100mg</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-7601001010604-6879301"
}
],
"indication" : "Paxlovid wird angewendet für die Behandlung der Coronavirus-Krankheit 2019 (COVID-19) bei Erwachsenen, die keine Sauerstofftherapie oder Hospitalisierung aufgrund von COVID-19 benötigen und bei denen ein erhöhtes Risiko für einen schweren Verlauf von COVID-19 besteht (siehe «Klinische Wirksamkeit»).\nPaxlovid ist nicht als Ersatz für eine Impfung gegen COVID-19 vorgesehen. Paxlovid sollte gemäss den offiziellen Empfehlungen und unter Berücksichtigung der lokalen epidemiologischen Daten zu zirkulierenden SARS-CoV-2-Varianten angewendet werden.",
"legalStatusOfSupply" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply",
"code" : "756005022002",
"display" : "Medicinal product subject to medical or veterinary prescription single dispensation (A+)"
}
]
},
"additionalMonitoringIndicator" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-additional-monitoring-indicator",
"code" : "756005001001",
"display" : "Black Triangle Warning"
}
]
},
"pediatricUseIndicator" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-pediatric-use-indicator",
"code" : "756005003002",
"display" : "Not authorised for the treatment in children"
}
]
},
"classification" : [
{
"coding" : [
{
"system" : "http://www.whocc.no/atc",
"code" : "J05AE"
}
]
},
{
"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" : "080000",
"display" : "08. INFEKTIONSKRANKHEITEN"
}
]
},
{
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus",
"code" : "080300",
"display" : "08.03. Mittel gegen Viren"
}
]
}
],
"attachedDocument" : [
{
🔗 "reference" : "DocumentReference/DocRef-FI-Paxlovid"
},
{
🔗 "reference" : "DocumentReference/DocRef-PI-Paxlovid"
}
],
"name" : [
{
"productName" : "PAXLOVID Filmtabl 4x150mg/2x100mg",
"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)"
}
]
}
}
]
}
]
}