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" : "6722a9ee-ae3b-4c20-bcf0-9b7cb6f062db",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle"
]
},
"type" : "collection",
"entry" : [
{
"fullUrl" : "http://example.org/MedicinalProductDefinition/Entocort-Solvent-and-Tablet",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "Entocort-Solvent-and-Tablet",
"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_Entocort-Solvent-and-Tablet\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition Entocort-Solvent-and-Tablet</b></p><a name=\"Entocort-Solvent-and-Tablet\"> </a><a name=\"hcEntocort-Solvent-and-Tablet\"> </a><a name=\"Entocort-Solvent-and-Tablet-en-US\"> </a><p><b>CH - SMC Authorized Dose Form</b>: <span title=\"Codes:{http://standardterms.edqm.eu 50064000}\">Tablet and solvent for rectal suspension</span></p><p><b>CH - EPL Full Limitation Text</b>: Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.</p><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID</code>/CH-7601001346451-5204201</p><p><b>domain</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000000004 100000000012}\">Human</span></p><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{http://standardterms.edqm.eu 50064000}\">Tablet and solvent for rectal suspension</span></p><p><b>indication</b>: </p><div><p>Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.</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 756005003001}\">Zugelassen für die Anwendung bei Kindern</span></p><p><b>classification</b>: <span title=\"Codes:{http://www.whocc.no/atc A07EA06}\">budesonide</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-Entocort.html\">DocumentReference: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber#123456789-initial submission-Example-efg-123; status = current; type = Fachinformation; date = 2022-04-01 00:00:00+0000</a></li><li><a href=\"DocumentReference-DocRef-PI-Entocort.html\">DocumentReference: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber#123456789-initial submission-Example-efg-321; status = current; type = Patienteninformation; date = 2022-04-01 00:00:00+0000</a></li></ul><blockquote><p><b>name</b></p><p><b>productName</b>: ENTOCORT Enema Klistier Lösung + Tabletten 7 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" : "50064000",
"display" : "Tablet and solvent for rectal suspension"
}
]
}
},
{
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/fullLimitationText",
"valueString" : "Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin."
}
],
"identifier" : [
{
"system" : "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID",
"value" : "CH-7601001346451-5204201"
}
],
"domain" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/100000000004",
"code" : "100000000012",
"display" : "Human"
}
]
},
"combinedPharmaceuticalDoseForm" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "50064000",
"display" : "Tablet and solvent for rectal suspension"
}
]
},
"indication" : "Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.",
"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" : "756005003001",
"display" : "Zugelassen für die Anwendung bei Kindern"
}
]
},
"classification" : [
{
"coding" : [
{
"system" : "http://www.whocc.no/atc",
"code" : "A07EA06"
}
]
},
{
"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-Entocort"
},
{
🔗 "reference" : "DocumentReference/DocRef-PI-Entocort"
}
],
"name" : [
{
"productName" : "ENTOCORT Enema Klistier Lösung + Tabletten 7 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-Entocort",
"resource" : {
"resourceType" : "DocumentReference",
"id" : "DocRef-FI-Entocort",
"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-Entocort\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference DocRef-FI-Entocort</b></p><a name=\"DocRef-FI-Entocort\"> </a><a name=\"hcDocRef-FI-Entocort\"> </a><a name=\"DocRef-FI-Entocort-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-efg-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>: 2022-04-01 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=52042&supportMultipleResults=1\">https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=52042&supportMultipleResults=1</a></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber",
"value" : "123456789-initial submission-Example-efg-123"
}
],
"status" : "current",
"type" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type",
"code" : "756005007001",
"display" : "Fachinformation"
}
]
},
"date" : "2022-04-01T00:00:00Z",
"content" : [
{
"attachment" : {
"url" : "https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=52042&supportMultipleResults=1"
}
}
]
}
},
{
"fullUrl" : "http://example.org/DocumentReference/DocRef-PI-Entocort",
"resource" : {
"resourceType" : "DocumentReference",
"id" : "DocRef-PI-Entocort",
"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-Entocort\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference DocRef-PI-Entocort</b></p><a name=\"DocRef-PI-Entocort\"> </a><a name=\"hcDocRef-PI-Entocort\"> </a><a name=\"DocRef-PI-Entocort-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-efg-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>: 2022-04-01 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=52042&supportMultipleResults=1\">https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&lang=DE&authNr=52042&supportMultipleResults=1</a></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber",
"value" : "123456789-initial submission-Example-efg-321"
}
],
"status" : "current",
"type" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type",
"code" : "756005007002",
"display" : "Patienteninformation"
}
]
},
"date" : "2022-04-01T00:00:00Z",
"content" : [
{
"attachment" : {
"url" : "https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&lang=DE&authNr=52042&supportMultipleResults=1"
}
}
]
}
},
{
"fullUrl" : "http://example.org/RegulatedAuthorisation/MA-5204201",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "MA-5204201",
"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-5204201\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-5204201</b></p><a name=\"MA-5204201\"> </a><a name=\"hcMA-5204201\"> </a><a name=\"MA-5204201-en-US\"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/5204201</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Entocort-Solvent-and-Tablet.html\">MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; domain = Human; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Zugelassen für die Anwendung bei Kindern; classification = budesonide,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>: 1993-06-18</p><p><b>holder</b>: <a href=\"#hcMA-5204201/holder-Tillotts-Pharma-AG\">Organization Tillotts Pharma AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-5204201/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Tillotts-Pharma-AG</b></p><a name=\"MA-5204201/holder-Tillotts-Pharma-AG\"> </a><a name=\"hcMA-5204201/holder-Tillotts-Pharma-AG\"> </a><a name=\"MA-5204201/holder-Tillotts-Pharma-AG-en-US\"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100005174, <a href=\"https://www.gs1.org/standards/id-keys/gln\" title=\"Global Location Number\">GLN</a>/7601001346451</p><p><b>name</b>: Tillotts Pharma AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name=\"MA-5204201/regulator-SMC\"> </a><a name=\"hcMA-5204201/regulator-SMC\"> </a><a name=\"MA-5204201/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-Tillotts-Pharma-AG",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier" : [
{
"system" : "urn:oid:1.2.276.0.76",
"value" : "100005174"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001346451"
}
],
"name" : "Tillotts Pharma 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" : "5204201"
}
],
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Entocort-Solvent-and-Tablet"
}
],
"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" : "1993-06-18",
"holder" : {
"reference" : "#holder-Tillotts-Pharma-AG"
},
"regulator" : {
"reference" : "#regulator-SMC"
}
}
},
{
"fullUrl" : "http://example.org/PackagedProductDefinition/PMP-Entocort-Solvent-and-Tablet",
"resource" : {
"resourceType" : "PackagedProductDefinition",
"id" : "PMP-Entocort-Solvent-and-Tablet",
"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-Entocort-Solvent-and-Tablet\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition PMP-Entocort-Solvent-and-Tablet</b></p><a name=\"PMP-Entocort-Solvent-and-Tablet\"> </a><a name=\"hcPMP-Entocort-Solvent-and-Tablet\"> </a><a name=\"PMP-Entocort-Solvent-and-Tablet-en-US\"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID</code>/CH-7601001346451-5204201-011</p><p><b>packageFor</b>: <a href=\"MedicinalProductDefinition-Entocort-Solvent-and-Tablet.html\">MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; domain = Human; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Zugelassen für die Anwendung bei Kindern; classification = budesonide,NA BWS Art 12. Abs. 5 VAZV,Synthetika,Originalpräparat</a></p><p><b>containedItemQuantity</b>: 7 Tablet<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code15054000 = 'Tablet')</span>, 7 Bottle<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code30008000 = 'Bottle')</span></p><p><b>description</b>: </p><div><p>ENTOCORT Enema Klistier Lösung + Tabletten 7 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>/7680520420118</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: 60; unit: month; system: http://unitsofmeasure.org; code: mo)</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage 756005042009}\">Nicht über 30°C</span></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID",
"value" : "CH-7601001346451-5204201-011"
}
],
"packageFor" : [
{
🔗 "reference" : "MedicinalProductDefinition/Entocort-Solvent-and-Tablet"
}
],
"containedItemQuantity" : [
{
"value" : 7,
"unit" : "Tablet",
"system" : "http://standardterms.edqm.eu",
"code" : "15054000"
},
{
"value" : 7,
"unit" : "Bottle",
"system" : "http://standardterms.edqm.eu",
"code" : "30008000"
}
],
"description" : "ENTOCORT Enema Klistier Lösung + Tabletten 7 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" : "7680520420118"
}
],
"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" : 60,
"unit" : "month",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"specialPrecautionsForStorage" : [
{
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage",
"code" : "756005042009",
"display" : "Nicht über 30°C"
}
]
}
]
}
]
}
}
},
{
"fullUrl" : "http://example.org/RegulatedAuthorisation/MA-52042011",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "MA-52042011",
"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-52042011\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-52042011</b></p><a name=\"MA-52042011\"> </a><a name=\"hcMA-52042011\"> </a><a name=\"MA-52042011-en-US\"> </a><p><b>identifier</b>: <code>http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber</code>/52042011</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Entocort-Solvent-and-Tablet.html\">MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; domain = Human; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Zugelassen für die Anwendung bei Kindern; classification = budesonide,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>: 1993-06-18</p><p><b>holder</b>: <a href=\"#hcMA-52042011/holder-Tillotts-Pharma-AG\">Organization Tillotts Pharma AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-52042011/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Tillotts-Pharma-AG</b></p><a name=\"MA-52042011/holder-Tillotts-Pharma-AG\"> </a><a name=\"hcMA-52042011/holder-Tillotts-Pharma-AG\"> </a><a name=\"MA-52042011/holder-Tillotts-Pharma-AG-en-US\"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100005174, <a href=\"https://www.gs1.org/standards/id-keys/gln\" title=\"Global Location Number\">GLN</a>/7601001346451</p><p><b>name</b>: Tillotts Pharma AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name=\"MA-52042011/regulator-SMC\"> </a><a name=\"hcMA-52042011/regulator-SMC\"> </a><a name=\"MA-52042011/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-Tillotts-Pharma-AG",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier" : [
{
"system" : "urn:oid:1.2.276.0.76",
"value" : "100005174"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001346451"
}
],
"name" : "Tillotts Pharma 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" : "52042011"
}
],
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Entocort-Solvent-and-Tablet"
}
],
"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" : "1993-06-18",
"holder" : {
"reference" : "#holder-Tillotts-Pharma-AG"
},
"regulator" : {
"reference" : "#regulator-SMC"
}
}
},
{
"fullUrl" : "http://example.org/RegulatedAuthorisation/FOPH-17973",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "FOPH-17973",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_FOPH-17973\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization FOPH-17973</b></p><a name=\"FOPH-17973\"> </a><a name=\"hcFOPH-17973\"> </a><a name=\"FOPH-17973-en-US\"> </a><blockquote><p><b>CH - EPL Reimbursement SL</b></p><ul><li>FOPHDossierNumber: <code>urn:oid:2.16.756.1</code>/17973</li><li>status: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status 756001021001}\">Reimbursed</span></li><li>statusDate: 2004-02-01</li><li>listingStatus: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status 756001002001}\">Listed</span></li><li>listingPeriod: 2004-02-01 --> (ongoing)</li><li>firstListingDate: 2004-02-01</li><li>costShare: 10</li><li>gamme: <span title=\"Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme 756002004005}\">RektalVaginal</span></li></ul></blockquote><blockquote><p><b>CH - EPL Product Price</b></p><ul><li>value: <span title=\"Swiss Franc\">CHF40.89</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: 2023-12-01</li></ul></blockquote><blockquote><p><b>CH - EPL Product Price</b></p><ul><li>value: <span title=\"Swiss Franc\">CHF63.40</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-Entocort-Solvent-and-Tablet.html\">PackagedProductDefinition: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID#CH-7601001346451-5204201-011; containedItemQuantity = 7 Tablet,7 Bottle; description = ENTOCORT Enema Klistier Lösung + Tabletten 7 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-10009900.html\">ClinicalUseDefinition: type = indication</a></td></tr></table><p><b>holder</b>: <a href=\"#hcFOPH-17973/holder-Tillotts-Pharma-AG\">Organization Tillotts Pharma AG</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Tillotts-Pharma-AG</b></p><a name=\"FOPH-17973/holder-Tillotts-Pharma-AG\"> </a><a name=\"hcFOPH-17973/holder-Tillotts-Pharma-AG\"> </a><a name=\"FOPH-17973/holder-Tillotts-Pharma-AG-en-US\"> </a><p><b>identifier</b>: <code>urn:oid:1.2.276.0.76</code>/100005174, <a href=\"https://www.gs1.org/standards/id-keys/gln\" title=\"Global Location Number\">GLN</a>/7601001346451</p><p><b>name</b>: Tillotts Pharma AG</p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Organization",
"id" : "holder-Tillotts-Pharma-AG",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization"
]
},
"identifier" : [
{
"system" : "urn:oid:1.2.276.0.76",
"value" : "100005174"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001346451"
}
],
"name" : "Tillotts Pharma AG"
}
],
"extension" : [
{
"extension" : [
{
"url" : "FOPHDossierNumber",
"valueIdentifier" : {
"system" : "urn:oid:2.16.756.1",
"value" : "17973"
}
},
{
"url" : "status",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status",
"code" : "756001021001",
"display" : "Reimbursed"
}
]
}
},
{
"url" : "statusDate",
"valueDate" : "2004-02-01"
},
{
"url" : "listingStatus",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status",
"code" : "756001002001",
"display" : "Listed"
}
]
}
},
{
"url" : "listingPeriod",
"valuePeriod" : {
"start" : "2004-02-01"
}
},
{
"url" : "firstListingDate",
"valueDate" : "2004-02-01"
},
{
"url" : "costShare",
"valueInteger" : 10
},
{
"url" : "gamme",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme",
"code" : "756002004005",
"display" : "RektalVaginal"
}
]
}
}
],
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL"
},
{
"extension" : [
{
"url" : "value",
"valueMoney" : {
"value" : 40.89,
"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" : "2023-12-01"
}
],
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
},
{
"extension" : [
{
"url" : "value",
"valueMoney" : {
"value" : 63.4,
"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-Entocort-Solvent-and-Tablet"
}
],
"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" : "2007-01-01"
},
{
"url" : "period",
"valuePeriod" : {
"start" : "2007-01-01"
}
},
{
"url" : "firstLimitationDate",
"valueDate" : "2007-01-01"
},
{
"extension" : [
{
"url" : "value",
"valueMoney" : {
"value" : 40.89,
"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" : "2023-12-01"
}
],
"url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice"
},
{
"extension" : [
{
"url" : "value",
"valueMoney" : {
"value" : 63.4,
"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-10009900"
}
}
],
"holder" : {
"reference" : "#holder-Tillotts-Pharma-AG"
}
}
},
{
"fullUrl" : "http://example.org/ManufacturedItemDefinition/MI-Budesonidum-2.3mg-Tablet",
"resource" : {
"resourceType" : "ManufacturedItemDefinition",
"id" : "MI-Budesonidum-2.3mg-Tablet",
"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-Budesonidum-2.3mg-Tablet\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition MI-Budesonidum-2.3mg-Tablet</b></p><a name=\"MI-Budesonidum-2.3mg-Tablet\"> </a><a name=\"hcMI-Budesonidum-2.3mg-Tablet\"> </a><a name=\"MI-Budesonidum-2.3mg-Tablet-en-US\"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{http://standardterms.edqm.eu 11012000}\">Tablet for rectal suspension</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{http://standardterms.edqm.eu 15054000}\">Tablet</span></p></div>"
},
"status" : "active",
"manufacturedDoseForm" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "11012000",
"display" : "Tablet for rectal suspension"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "15054000",
"display" : "Tablet"
}
]
}
}
},
{
"fullUrl" : "http://example.org/ManufacturedItemDefinition/MI-Solvent",
"resource" : {
"resourceType" : "ManufacturedItemDefinition",
"id" : "MI-Solvent",
"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-Solvent\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition MI-Solvent</b></p><a name=\"MI-Solvent\"> </a><a name=\"hcMI-Solvent\"> </a><a name=\"MI-Solvent-en-US\"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{http://standardterms.edqm.eu 13035000}\">Solvent for...</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{http://standardterms.edqm.eu 15009000}\">Bottle</span></p></div>"
},
"status" : "active",
"manufacturedDoseForm" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "13035000",
"display" : "Solvent for..."
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "15009000",
"display" : "Bottle"
}
]
}
}
},
{
"fullUrl" : "http://example.org/AdministrableProductDefinition/PhP-Budesonidum-Suspension",
"resource" : {
"resourceType" : "AdministrableProductDefinition",
"id" : "PhP-Budesonidum-Suspension",
"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-Budesonidum-Suspension\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition PhP-Budesonidum-Suspension</b></p><a name=\"PhP-Budesonidum-Suspension\"> </a><a name=\"hcPhP-Budesonidum-Suspension\"> </a><a name=\"PhP-Budesonidum-Suspension-en-US\"> </a><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"MedicinalProductDefinition-Entocort-Solvent-and-Tablet.html\">MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; domain = Human; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Zugelassen für die Anwendung bei Kindern; classification = budesonide,NA BWS Art 12. Abs. 5 VAZV,Synthetika,Originalpräparat</a></p><p><b>administrableDoseForm</b>: <span title=\"Codes:{http://standardterms.edqm.eu 11006000}\">Rectal suspension</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{http://standardterms.edqm.eu 15009000}\">Bottle</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 20061000}\">Rectal use</span></td></tr></table></div>"
},
"status" : "active",
"formOf" : [
{
🔗 "reference" : "MedicinalProductDefinition/Entocort-Solvent-and-Tablet"
}
],
"administrableDoseForm" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "11006000",
"display" : "Rectal suspension"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "15009000",
"display" : "Bottle"
}
]
},
"routeOfAdministration" : [
{
"code" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "20061000",
"display" : "Rectal use"
}
]
}
}
]
}
},
{
"fullUrl" : "http://example.org/ClinicalUseDefinition/IND-10009900",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "IND-10009900",
"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-10009900\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10009900</b></p><a name=\"IND-10009900\"> </a><a name=\"hcIND-10009900\"> </a><a name=\"IND-10009900-en-US\"> </a><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-Entocort-Solvent-and-Tablet.html\">MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; domain = Human; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Abgabe auf ärztliche oder tierärztliche Verschreibung (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Zugelassen für die Anwendung bei Kindern; classification = budesonide,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 10009900}\">Colitis ulcerative</span></td></tr></table><h3>IntendedEffects</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000003186 200000003194}\">therapeutic</span></td></tr></table></blockquote></div>"
},
"type" : "indication",
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Entocort-Solvent-and-Tablet"
}
],
"indication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10009900",
"display" : "Colitis ulcerative"
}
]
}
},
"intendedEffect" : {
"concept" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/200000003186",
"code" : "200000003194",
"display" : "therapeutic"
}
]
}
}
}
}
},
{
"fullUrl" : "http://example.org/Ingredient/Budesonidum2.3",
"resource" : {
"resourceType" : "Ingredient",
"id" : "Budesonidum2.3",
"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_Budesonidum2.3\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient Budesonidum2.3</b></p><a name=\"Budesonidum2.3\"> </a><a name=\"hcBudesonidum2.3\"> </a><a name=\"Budesonidum2.3-en-US\"> </a><p><b>status</b>: Active</p><p><b>for</b>: <a href=\"ManufacturedItemDefinition-MI-Budesonidum-2.3mg-Tablet.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet for rectal suspension; unitOfPresentation = Tablet</a></p><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 Q3OKS62Q6X}\">Budesonide</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>2.3 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span>/1 Tablet<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code15054000 = 'Tablet')</span></td></tr></table></blockquote></div>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "ManufacturedItemDefinition/MI-Budesonidum-2.3mg-Tablet"
}
],
"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" : "Q3OKS62Q6X",
"display" : "Budesonide"
}
]
}
},
"strength" : [
{
"presentationRatio" : {
"numerator" : {
"value" : 2.3,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
},
"denominator" : {
"value" : 1,
"unit" : "Tablet",
"system" : "http://standardterms.edqm.eu",
"code" : "15054000"
}
}
}
]
}
}
},
{
"fullUrl" : "http://example.org/Ingredient/Budesonidum2.0",
"resource" : {
"resourceType" : "Ingredient",
"id" : "Budesonidum2.0",
"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_Budesonidum2.0\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient Budesonidum2.0</b></p><a name=\"Budesonidum2.0\"> </a><a name=\"hcBudesonidum2.0\"> </a><a name=\"Budesonidum2.0-en-US\"> </a><p><b>status</b>: Active</p><p><b>for</b>: <a href=\"AdministrableProductDefinition-PhP-Budesonidum-Suspension.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Rectal suspension; unitOfPresentation = Bottle</a></p><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 Q3OKS62Q6X}\">Budesonide</span></td></tr></table><h3>Strengths</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concentration[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span>/100 ml<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeml = 'ml')</span></td></tr></table></blockquote></div>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "AdministrableProductDefinition/PhP-Budesonidum-Suspension"
}
],
"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" : "Q3OKS62Q6X",
"display" : "Budesonide"
}
]
}
},
"strength" : [
{
"concentrationRatio" : {
"numerator" : {
"value" : 2,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
},
"denominator" : {
"value" : 100,
"unit" : "ml",
"system" : "http://unitsofmeasure.org",
"code" : "ml"
}
}
}
]
}
}
}
]
}