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" : "5bb930aa-f30d-4f10-aeef-e85f6b5f8d59",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle"
]
},
"type" : "collection",
"entry" : [
{
"fullUrl" : "http://example.org/MedicinalProductDefinition/Estalis-Transdermalpatch",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "Estalis-Transdermalpatch",
"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_Estalis-Transdermalpatch\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition Estalis-Transdermalpatch</b></p><a name=\"Estalis-Transdermalpatch\"> </a><a name=\"hcEstalis-Transdermalpatch\"> </a><a name=\"Estalis-Transdermalpatch-en-US\"> </a><p><b>CH - SMC Authorized Dose Form</b>: <span title=\"Codes:{http://standardterms.edqm.eu 10519000}\">Transdermal patch</span></p><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID</code>/CH-7601001029439-5470402</p><p><b>domain</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000000004 100000000012}\">Human</span></p><p><b>indication</b>: </p><div><p>Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.\nOsteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.</p>\n</div><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply 756005022003}\">Abgabe auf ärztliche oder tierärztliche Verschreibung (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 756005003002}\">Nicht zugelassen für die Anwendung bei Kindern</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-authorisation-category 756005021001}\">NA BWS Art 12. Abs. 5 VAZV</span>, <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode 756005004001}\">Synthetika</span>, <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type 756001003002}\">Originalpräparat</span></p><p><b>attachedDocument</b>: </p><ul><li><a href=\"DocumentReference-DocRef-FI-Estalis.html\">DocumentReference: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber#123456789-initial submission-Example-hij-123; status = current; type = Fachinformation; date = 2021-10-01 00:00:00+0000</a></li><li><a href=\"DocumentReference-DocRef-PI-Estalis.html\">DocumentReference: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber#123456789-initial submission-Example-hij-321; status = current; type = Patienteninformation; date = 2021-10-01 00:00:00+0000</a></li></ul><blockquote><p><b>name</b></p><p><b>productName</b>: ESTALIS Matrixpfl 50/250 24 Stk</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" : "10519000",
"display" : "Transdermal patch"
}
]
}
}
],
"identifier" : [
{
"system" : "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID",
"value" : "CH-7601001029439-5470402"
}
],
"domain" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/100000000004",
"code" : "100000000012",
"display" : "Human"
}
]
},
"indication" : "Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.\nOsteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.",
"legalStatusOfSupply" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply",
"code" : "756005022003",
"display" : "Abgabe auf ärztliche oder tierärztliche Verschreibung (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" : "756005003002",
"display" : "Nicht zugelassen für die Anwendung bei Kindern"
}
]
},
"classification" : [
{
"coding" : [
{
"system" : "http://www.whocc.no/atc",
"code" : "G03FA01"
}
]
},
{
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-category",
"code" : "756005021001",
"display" : "NA BWS Art 12. Abs. 5 VAZV"
}
]
},
{
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode",
"code" : "756005004001",
"display" : "Synthetika"
}
]
},
{
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type",
"code" : "756001003002",
"display" : "Originalpräparat"
}
]
}
],
"attachedDocument" : [
{
🔗 "reference" : "DocumentReference/DocRef-FI-Estalis"
},
{
🔗 "reference" : "DocumentReference/DocRef-PI-Estalis"
}
],
"name" : [
{
"productName" : "ESTALIS Matrixpfl 50/250 24 Stk",
"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://example.org/DocumentReference/DocRef-FI-Estalis",
"resource" : {
"resourceType" : "DocumentReference",
"id" : "DocRef-FI-Estalis",
"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-Estalis\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference DocRef-FI-Estalis</b></p><a name=\"DocRef-FI-Estalis\"> </a><a name=\"hcDocRef-FI-Estalis\"> </a><a name=\"DocRef-FI-Estalis-en-US\"> </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>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber</code>/123456789-initial submission-Example-hij-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>: 2021-10-01 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/showTextAccepted.aspx?textType=FI&lang=DE&authNr=54704&supportMultipleResults=1\">https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=54704&supportMultipleResults=1</a></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber",
"value" : "123456789-initial submission-Example-hij-123"
}
],
"status" : "current",
"type" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type",
"code" : "756005007001",
"display" : "Fachinformation"
}
]
},
"date" : "2021-10-01T00:00:00Z",
"content" : [
{
"attachment" : {
"url" : "https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=54704&supportMultipleResults=1"
}
}
]
}
},
{
"fullUrl" : "http://example.org/DocumentReference/DocRef-PI-Estalis",
"resource" : {
"resourceType" : "DocumentReference",
"id" : "DocRef-PI-Estalis",
"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-Estalis\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference DocRef-PI-Estalis</b></p><a name=\"DocRef-PI-Estalis\"> </a><a name=\"hcDocRef-PI-Estalis\"> </a><a name=\"DocRef-PI-Estalis-en-US\"> </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>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber</code>/123456789-initial submission-Example-hij-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>: 2021-10-01 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/showTextAccepted.aspx?textType=PI&lang=DE&authNr=54704&supportMultipleResults=1\">https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&lang=DE&authNr=54704&supportMultipleResults=1</a></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber",
"value" : "123456789-initial submission-Example-hij-321"
}
],
"status" : "current",
"type" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type",
"code" : "756005007002",
"display" : "Patienteninformation"
}
]
},
"date" : "2021-10-01T00:00:00Z",
"content" : [
{
"attachment" : {
"url" : "https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&lang=DE&authNr=54704&supportMultipleResults=1"
}
}
]
}
},
{
"fullUrl" : "http://example.org/RegulatedAuthorisation/MA-5470402",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "MA-5470402",
"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-5470402\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-5470402</b></p><a name=\"MA-5470402\"> </a><a name=\"hcMA-5470402\"> </a><a name=\"MA-5470402-en-US\"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/5470402</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Estalis-Transdermalpatch.html\">MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = Human; indication = Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.\nOsteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Nicht zugelassen für die Anwendung bei Kindern; classification = norethisterone and estrogen,NA BWS Art 12. Abs. 5 VAZV,Synthetika,Originalpräparat</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}\">zugelassen</span></p><p><b>statusDate</b>: 1999-08-17</p><p><b>holder</b>: <a href=\"#hcMA-5470402/holder-Sandoz-Pharmaceuticals-AG\">Organization Sandoz Pharmaceuticals AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-5470402/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG</b></p><a name=\"MA-5470402/holder-Sandoz-Pharmaceuticals-AG\"> </a><a name=\"hcMA-5470402/holder-Sandoz-Pharmaceuticals-AG\"> </a><a name=\"MA-5470402/holder-Sandoz-Pharmaceuticals-AG-en-US\"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100054743, <a href=\"https://www.gs1.org/standards/id-keys/gln\" title=\"Global Location Number\">GLN</a>/7601001029439</p><p><b>name</b>: Sandoz Pharmaceuticals AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name=\"MA-5470402/regulator-SMC\"> </a><a name=\"hcMA-5470402/regulator-SMC\"> </a><a name=\"MA-5470402/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-Sandoz-Pharmaceuticals-AG",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier" : [
{
"system" : "urn:oid:1.2.276.0.76",
"value" : "100054743"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001029439"
}
],
"name" : "Sandoz Pharmaceuticals 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" : "5470402"
}
],
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Estalis-Transdermalpatch"
}
],
"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" : "zugelassen"
}
]
},
"statusDate" : "1999-08-17",
"holder" : {
"reference" : "#holder-Sandoz-Pharmaceuticals-AG"
},
"regulator" : {
"reference" : "#regulator-SMC"
}
}
},
{
"fullUrl" : "http://example.org/PackagedProductDefinition/PMP-Estalis-Transdermalpatch",
"resource" : {
"resourceType" : "PackagedProductDefinition",
"id" : "PMP-Estalis-Transdermalpatch",
"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-Estalis-Transdermalpatch\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition PMP-Estalis-Transdermalpatch</b></p><a name=\"PMP-Estalis-Transdermalpatch\"> </a><a name=\"hcPMP-Estalis-Transdermalpatch\"> </a><a name=\"PMP-Estalis-Transdermalpatch-en-US\"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID</code>/CH-7601001029439-5470402-097</p><p><b>packageFor</b>: <a href=\"MedicinalProductDefinition-Estalis-Transdermalpatch.html\">MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = Human; indication = Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.\nOsteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Nicht zugelassen für die Anwendung bei Kindern; classification = norethisterone and estrogen,NA BWS Art 12. Abs. 5 VAZV,Synthetika,Originalpräparat</a></p><p><b>containedItemQuantity</b>: 24 Patch<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code15036000 = 'Patch')</span></p><p><b>description</b>: </p><div><p>ESTALIS Matrixpfl 50/250 24 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}\">Abgabe auf ärztliche oder tierärztliche Verschreibung (B)</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <code>urn:oid:2.51.1.1</code>/7680547040979</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: 6; 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 756005042004}\">vor Licht Schützen</span></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID",
"value" : "CH-7601001029439-5470402-097"
}
],
"packageFor" : [
{
🔗 "reference" : "MedicinalProductDefinition/Estalis-Transdermalpatch"
}
],
"containedItemQuantity" : [
{
"value" : 24,
"unit" : "Patch",
"system" : "http://standardterms.edqm.eu",
"code" : "15036000"
}
],
"description" : "ESTALIS Matrixpfl 50/250 24 Stk",
"legalStatusOfSupply" : [
{
"code" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply",
"code" : "756005022003",
"display" : "Abgabe auf ärztliche oder tierärztliche Verschreibung (B)"
}
]
}
}
],
"packaging" : {
"identifier" : [
{
"system" : "urn:oid:2.51.1.1",
"value" : "7680547040979"
}
],
"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" : 6,
"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" : "756005042004",
"display" : "vor Licht Schützen"
}
]
}
]
}
]
}
}
},
{
"fullUrl" : "http://example.org/RegulatedAuthorisation/MA-54704089",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "MA-54704089",
"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-54704089\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-54704089</b></p><a name=\"MA-54704089\"> </a><a name=\"hcMA-54704089\"> </a><a name=\"MA-54704089-en-US\"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/54704089</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Estalis-Transdermalpatch.html\">MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = Human; indication = Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.\nOsteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Nicht zugelassen für die Anwendung bei Kindern; classification = norethisterone and estrogen,NA BWS Art 12. Abs. 5 VAZV,Synthetika,Originalpräparat</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}\">zugelassen</span></p><p><b>statusDate</b>: 1999-08-17</p><p><b>holder</b>: <a href=\"#hcMA-54704089/holder-Sandoz-Pharmaceuticals-AG\">Organization Sandoz Pharmaceuticals AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-54704089/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG</b></p><a name=\"MA-54704089/holder-Sandoz-Pharmaceuticals-AG\"> </a><a name=\"hcMA-54704089/holder-Sandoz-Pharmaceuticals-AG\"> </a><a name=\"MA-54704089/holder-Sandoz-Pharmaceuticals-AG-en-US\"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100054743, <a href=\"https://www.gs1.org/standards/id-keys/gln\" title=\"Global Location Number\">GLN</a>/7601001029439</p><p><b>name</b>: Sandoz Pharmaceuticals AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name=\"MA-54704089/regulator-SMC\"> </a><a name=\"hcMA-54704089/regulator-SMC\"> </a><a name=\"MA-54704089/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-Sandoz-Pharmaceuticals-AG",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier" : [
{
"system" : "urn:oid:1.2.276.0.76",
"value" : "100054743"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001029439"
}
],
"name" : "Sandoz Pharmaceuticals 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" : "54704089"
}
],
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Estalis-Transdermalpatch"
}
],
"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" : "zugelassen"
}
]
},
"statusDate" : "1999-08-17",
"holder" : {
"reference" : "#holder-Sandoz-Pharmaceuticals-AG"
},
"regulator" : {
"reference" : "#regulator-SMC"
}
}
},
{
"fullUrl" : "http://example.org/RegulatedAuthorisation/FOPH-17418",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "FOPH-17418",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_FOPH-17418\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization FOPH-17418</b></p><a name=\"FOPH-17418\"> </a><a name=\"hcFOPH-17418\"> </a><a name=\"FOPH-17418-en-US\"> </a><blockquote><p><b>CH - EPL Reimbursement SL</b></p><ul><li>FOPHDossierNumber: <code>urn:oid:2.16.756.1</code>/17418</li><li>status: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status 756001021001}\">Reimbursed</span></li><li>statusDate: 2000-04-15</li><li>listingStatus: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status 756001002001}\">Listed</span></li><li>listingPeriod: 2000-04-15 --> (ongoing)</li><li>firstListingDate: 2000-04-15</li><li>costShare: 10</li><li>gamme: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme 756002004011}\">Transdermal</span></li></ul></blockquote><blockquote><p><b>CH - EPL Product Price</b></p><ul><li>value: <span title=\"Swiss Franc\">CHF32.44</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 756002006007}\">Price mutation after triennal review of pharmaceuticals</span></li><li>changeDate: 2014-11-01</li></ul></blockquote><blockquote><p><b>CH - EPL Product Price</b></p><ul><li>value: <span title=\"Swiss Franc\">CHF53.65</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-Estalis-Transdermalpatch.html\">PackagedProductDefinition: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID#CH-7601001029439-5470402-097; containedItemQuantity = 24 Patch; description = ESTALIS Matrixpfl 50/250 24 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-10031285.html\">ClinicalUseDefinition: type = indication</a></td></tr></table><p><b>holder</b>: <a href=\"#hcFOPH-17418/holder-Sandoz-Pharmaceuticals-AG\">Organization Sandoz Pharmaceuticals AG</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG</b></p><a name=\"FOPH-17418/holder-Sandoz-Pharmaceuticals-AG\"> </a><a name=\"hcFOPH-17418/holder-Sandoz-Pharmaceuticals-AG\"> </a><a name=\"FOPH-17418/holder-Sandoz-Pharmaceuticals-AG-en-US\"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100054743, <a href=\"https://www.gs1.org/standards/id-keys/gln\" title=\"Global Location Number\">GLN</a>/7601001029439</p><p><b>name</b>: Sandoz Pharmaceuticals AG</p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Organization",
"id" : "holder-Sandoz-Pharmaceuticals-AG",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier" : [
{
"system" : "urn:oid:1.2.276.0.76",
"value" : "100054743"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001029439"
}
],
"name" : "Sandoz Pharmaceuticals AG"
}
],
"extension" : [
{
"extension" : [
{
"url" : "FOPHDossierNumber",
"valueIdentifier" : {
"system" : "urn:oid:2.16.756.1",
"value" : "17418"
}
},
{
"url" : "status",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status",
"code" : "756001021001",
"display" : "Reimbursed"
}
]
}
},
{
"url" : "statusDate",
"valueDate" : "2000-04-15"
},
{
"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" : "2000-04-15"
}
},
{
"url" : "firstListingDate",
"valueDate" : "2000-04-15"
},
{
"url" : "costShare",
"valueInteger" : 10
},
{
"url" : "gamme",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme",
"code" : "756002004011",
"display" : "Transdermal"
}
]
}
}
],
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL"
},
{
"extension" : [
{
"url" : "value",
"valueMoney" : {
"value" : 32.44,
"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" : "2014-11-01"
}
],
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
},
{
"extension" : [
{
"url" : "value",
"valueMoney" : {
"value" : 53.65,
"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-Estalis-Transdermalpatch"
}
],
"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" : "2000-04-15"
},
{
"url" : "period",
"valuePeriod" : {
"start" : "2000-04-15"
}
},
{
"url" : "firstLimitationDate",
"valueDate" : "2000-04-15"
},
{
"extension" : [
{
"url" : "value",
"valueMoney" : {
"value" : 32.44,
"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" : "2014-11-01"
}
],
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
},
{
"extension" : [
{
"url" : "value",
"valueMoney" : {
"value" : 53.65,
"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-10031285"
}
}
],
"holder" : {
"reference" : "#holder-Sandoz-Pharmaceuticals-AG"
}
}
},
{
"fullUrl" : "http://example.org/ManufacturedItemDefinition/MI-Estradiolum-Norethisteroni-Transdermalpatch",
"resource" : {
"resourceType" : "ManufacturedItemDefinition",
"id" : "MI-Estradiolum-Norethisteroni-Transdermalpatch",
"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-Estradiolum-Norethisteroni-Transdermalpatch\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition MI-Estradiolum-Norethisteroni-Transdermalpatch</b></p><a name=\"MI-Estradiolum-Norethisteroni-Transdermalpatch\"> </a><a name=\"hcMI-Estradiolum-Norethisteroni-Transdermalpatch\"> </a><a name=\"MI-Estradiolum-Norethisteroni-Transdermalpatch-en-US\"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{http://standardterms.edqm.eu 10519000}\">Transdermal patch</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{http://standardterms.edqm.eu 15036000}\">Patch</span></p></div>"
},
"status" : "active",
"manufacturedDoseForm" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "10519000",
"display" : "Transdermal patch"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "15036000",
"display" : "Patch"
}
]
}
}
},
{
"fullUrl" : "http://example.org/AdministrableProductDefinition/PhP-Estradiolum-Norethisteroni-Transdermalpatch",
"resource" : {
"resourceType" : "AdministrableProductDefinition",
"id" : "PhP-Estradiolum-Norethisteroni-Transdermalpatch",
"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-Estradiolum-Norethisteroni-Transdermalpatch\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition PhP-Estradiolum-Norethisteroni-Transdermalpatch</b></p><a name=\"PhP-Estradiolum-Norethisteroni-Transdermalpatch\"> </a><a name=\"hcPhP-Estradiolum-Norethisteroni-Transdermalpatch\"> </a><a name=\"PhP-Estradiolum-Norethisteroni-Transdermalpatch-en-US\"> </a><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"MedicinalProductDefinition-Estalis-Transdermalpatch.html\">MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = Human; indication = Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.\nOsteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Nicht zugelassen für die Anwendung bei Kindern; classification = norethisterone and estrogen,NA BWS Art 12. Abs. 5 VAZV,Synthetika,Originalpräparat</a></p><p><b>administrableDoseForm</b>: <span title=\"Codes:{http://standardterms.edqm.eu 10519000}\">Transdermal patch</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{http://standardterms.edqm.eu 15036000}\">Patch</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 20070000}\">Transdermal use</span></td></tr></table></div>"
},
"status" : "active",
"formOf" : [
{
🔗 "reference" : "MedicinalProductDefinition/Estalis-Transdermalpatch"
}
],
"administrableDoseForm" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "10519000",
"display" : "Transdermal patch"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "15036000",
"display" : "Patch"
}
]
},
"routeOfAdministration" : [
{
"code" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "20070000",
"display" : "Transdermal use"
}
]
}
}
]
}
},
{
"fullUrl" : "http://example.org/ClinicalUseDefinition/IND-10030247",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "IND-10030247",
"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-10030247\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10030247</b></p><a name=\"IND-10030247\"> </a><a name=\"hcIND-10030247\"> </a><a name=\"IND-10030247-en-US\"> </a><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Estalis-Transdermalpatch.html\">MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = Human; indication = Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.\nOsteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Nicht zugelassen für die Anwendung bei Kindern; classification = norethisterone and estrogen,NA BWS Art 12. Abs. 5 VAZV,Synthetika,Originalpräparat</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 10030247}\">Oestrogenmangel</span></td></tr></table><h3>Comorbidities</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 10027308}\">Menopause</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 200000003192}\">preventive</span></td></tr></table></blockquote></div>"
},
"type" : "indication",
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Estalis-Transdermalpatch"
}
],
"indication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10030247",
"display" : "Oestrogenmangel"
}
]
}
},
"comorbidity" : [
{
"concept" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10027308",
"display" : "Menopause"
}
]
}
}
],
"intendedEffect" : {
"concept" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/200000003186",
"code" : "200000003192",
"display" : "preventive"
}
]
}
}
}
}
},
{
"fullUrl" : "http://example.org/ClinicalUseDefinition/IND-10031285",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "IND-10031285",
"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-10031285\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10031285</b></p><a name=\"IND-10031285\"> </a><a name=\"hcIND-10031285\"> </a><a name=\"IND-10031285-en-US\"> </a><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Estalis-Transdermalpatch.html\">MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = Human; indication = Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.\nOsteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Nicht zugelassen für die Anwendung bei Kindern; classification = norethisterone and estrogen,NA BWS Art 12. Abs. 5 VAZV,Synthetika,Originalpräparat</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 10031285}\">Osteoporose postmenopausal</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 200000003192}\">preventive</span></td></tr></table></blockquote></div>"
},
"type" : "indication",
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Estalis-Transdermalpatch"
}
],
"indication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10031285",
"display" : "Osteoporose postmenopausal"
}
]
}
},
"intendedEffect" : {
"concept" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/200000003186",
"code" : "200000003192",
"display" : "preventive"
}
]
}
}
}
}
},
{
"fullUrl" : "http://example.org/Ingredient/Estradiol-hemihydrate-0.512mg",
"resource" : {
"resourceType" : "Ingredient",
"id" : "Estradiol-hemihydrate-0.512mg",
"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_Estradiol-hemihydrate-0.512mg\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient Estradiol-hemihydrate-0.512mg</b></p><a name=\"Estradiol-hemihydrate-0.512mg\"> </a><a name=\"hcEstradiol-hemihydrate-0.512mg\"> </a><a name=\"Estradiol-hemihydrate-0.512mg-en-US\"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Estradiolum-Norethisteroni-Transdermalpatch.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Transdermal patch; unitOfPresentation = Patch</a></li><li><a href=\"ManufacturedItemDefinition-MI-Estradiolum-Norethisteroni-Transdermalpatch.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Transdermal patch; unitOfPresentation = Patch</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role 756005051001}\">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 CXY7B3Q98Z}\">Estradiol-hemihydrate</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>0.512 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span>/1 Patch<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code15036000 = 'Patch')</span></td></tr></table></blockquote></div>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "AdministrableProductDefinition/PhP-Estradiolum-Norethisteroni-Transdermalpatch"
},
{
🔗 "reference" : "ManufacturedItemDefinition/MI-Estradiolum-Norethisteroni-Transdermalpatch"
}
],
"role" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role",
"code" : "756005051001",
"display" : "Wirkstoff"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-substance",
"code" : "CXY7B3Q98Z",
"display" : "Estradiol-hemihydrate"
}
]
}
},
"strength" : [
{
"presentationRatio" : {
"numerator" : {
"value" : 0.512,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
},
"denominator" : {
"value" : 1,
"unit" : "Patch",
"system" : "http://standardterms.edqm.eu",
"code" : "15036000"
}
}
}
]
}
}
},
{
"fullUrl" : "http://example.org/Ingredient/Norethisteroni-acetas-0.496mg",
"resource" : {
"resourceType" : "Ingredient",
"id" : "Norethisteroni-acetas-0.496mg",
"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_Norethisteroni-acetas-0.496mg\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient Norethisteroni-acetas-0.496mg</b></p><a name=\"Norethisteroni-acetas-0.496mg\"> </a><a name=\"hcNorethisteroni-acetas-0.496mg\"> </a><a name=\"Norethisteroni-acetas-0.496mg-en-US\"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Estradiolum-Norethisteroni-Transdermalpatch.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Transdermal patch; unitOfPresentation = Patch</a></li><li><a href=\"ManufacturedItemDefinition-MI-Estradiolum-Norethisteroni-Transdermalpatch.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Transdermal patch; unitOfPresentation = Patch</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role 756005051001}\">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 9S44LIC7OJ}\">Norethisterone acetate</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>0.496 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span>/1 Patch<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code15036000 = 'Patch')</span></td></tr></table></blockquote></div>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "AdministrableProductDefinition/PhP-Estradiolum-Norethisteroni-Transdermalpatch"
},
{
🔗 "reference" : "ManufacturedItemDefinition/MI-Estradiolum-Norethisteroni-Transdermalpatch"
}
],
"role" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role",
"code" : "756005051001",
"display" : "Wirkstoff"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-substance",
"code" : "9S44LIC7OJ",
"display" : "Norethisterone acetate"
}
]
}
},
"strength" : [
{
"presentationRatio" : {
"numerator" : {
"value" : 0.496,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
},
"denominator" : {
"value" : 1,
"unit" : "Patch",
"system" : "http://standardterms.edqm.eu",
"code" : "15036000"
}
}
}
]
}
}
}
]
}