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:{urn:oid:0.4.0.127.0.16.1.1.2.1 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:{urn:oid:1.2.276.0.76 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}\">Dispensation on medical or veterinary prescription (B)</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 S}\">Synthetika</span></p><p><b>attachedDocument</b>: </p><ul><li><a href=\"DocumentReference-DocRef-FI-Estalis.html\">DocumentReference: status = current; type = Fachinformation</a></li><li><a href=\"DocumentReference-DocRef-PI-Estalis.html\">DocumentReference: status = current; type = Patienteninformation</a></li></ul><blockquote><p><b>name</b></p><p><b>productName</b>: ESTALIS Matrixpfl 50/250 24 Stk</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" : "10519000",
"display" : "Transdermal patch"
}
]
}
}
],
"identifier" : [
{
"system" : "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID",
"value" : "CH-7601001029439-5470402"
}
],
"domain" : {
"coding" : [
{
"system" : "urn:oid:1.2.276.0.76",
"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" : "Dispensation on medical or veterinary prescription (B)"
}
]
},
"classification" : [
{
"coding" : [
{
"system" : "http://www.whocc.no/atc",
"code" : "G03FA01"
}
]
},
{
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode",
"code" : "S",
"display" : "Synthetika"
}
]
}
],
"attachedDocument" : [
{
🔗 "reference" : "DocumentReference/DocRef-FI-Estalis"
},
{
🔗 "reference" : "DocumentReference/DocRef-PI-Estalis"
}
],
"name" : [
{
"productName" : "ESTALIS Matrixpfl 50/250 24 Stk",
"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"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><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><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=54704&supportMultipleResults=1\">https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=54704&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=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"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><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><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 PI}\">Patienteninformation</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=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>"
},
"status" : "current",
"type" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type",
"code" : "PI",
"display" : "Patienteninformation"
}
]
},
"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 = Dispensation on medical or veterinary prescription (B); classification = norethisterone and estrogen,Synthetika</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>: 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" : "Z",
"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 = Dispensation on medical or veterinary prescription (B); classification = norethisterone and estrogen,Synthetika</a></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}\">Dispensation on medical or veterinary prescription (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:{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>Period[x]</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>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 L}\">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"
}
],
"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" : "Dispensation on medical or veterinary prescription (B)"
}
]
}
}
],
"packaging" : {
"identifier" : [
{
"system" : "urn:oid:2.51.1.1",
"value" : "7680547040979"
}
],
"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"
}
]
},
"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" : "L",
"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 = Dispensation on medical or veterinary prescription (B); classification = norethisterone and estrogen,Synthetika</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>: 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" : "Z",
"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; 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:{urn:oid:0.4.0.127.0.16.1.1.2.1 10519000}\">Transdermal patch</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{urn:oid:0.4.0.127.0.16.1.1.2.1 15036000}\">Patch</span></p></div>"
},
"status" : "active",
"manufacturedDoseForm" : {
"coding" : [
{
"system" : "urn:oid:0.4.0.127.0.16.1.1.2.1",
"code" : "10519000",
"display" : "Transdermal patch"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "urn:oid:0.4.0.127.0.16.1.1.2.1",
"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 = Dispensation on medical or veterinary prescription (B); classification = norethisterone and estrogen,Synthetika</a></p><p><b>administrableDoseForm</b>: <span title=\"Codes:{urn:oid:0.4.0.127.0.16.1.1.2.1 10519000}\">Transdermal patch</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{urn:oid:0.4.0.127.0.16.1.1.2.1 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:{urn:oid:0.4.0.127.0.16.1.1.2.1 20070000}\">Transdermal use</span></td></tr></table></div>"
},
"status" : "active",
"formOf" : [
{
🔗 "reference" : "MedicinalProductDefinition/Estalis-Transdermalpatch"
}
],
"administrableDoseForm" : {
"coding" : [
{
"system" : "urn:oid:0.4.0.127.0.16.1.1.2.1",
"code" : "10519000",
"display" : "Transdermal patch"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "urn:oid:0.4.0.127.0.16.1.1.2.1",
"code" : "15036000",
"display" : "Patch"
}
]
},
"routeOfAdministration" : [
{
"code" : {
"coding" : [
{
"system" : "urn:oid:0.4.0.127.0.16.1.1.2.1",
"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 = Dispensation on medical or veterinary prescription (B); classification = norethisterone and estrogen,Synthetika</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:{urn:oid:1.2.276.0.76 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" : "urn:oid:1.2.276.0.76",
"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 = Dispensation on medical or veterinary prescription (B); classification = norethisterone and estrogen,Synthetika</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:{urn:oid:1.2.276.0.76 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" : "urn:oid:1.2.276.0.76",
"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 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 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" : "WIRKS",
"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" : "urn:oid:0.4.0.127.0.16.1.1.2.1",
"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 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 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" : "WIRKS",
"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" : "urn:oid:0.4.0.127.0.16.1.1.2.1",
"code" : "15036000"
}
}
}
]
}
}
}
]
}