Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. 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/hl7-eu/gravitate-health/ and changes regularly. See the Directory of published versions
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:identifier [ fhir:system [ fhir:v "https://www.gravitatehealth.eu/sid/doc"^^xsd:anyURI ] ; fhir:value [ fhir:v "deca01585a8d920f79dbfbe328e7acda" ] ] ; # fhir:type [ fhir:v "document"] ; # fhir:timestamp [ fhir:v "2023-06-27T10:09:22Z"^^xsd:dateTime] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/Composition/composition-en-25bbfa948f4a0b224f9baa1fe481efa8"^^xsd:anyURI ] ; ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/Composition/composition-en-25bbfa948f4a0b224f9baa1fe481efa8> ) ] [ fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-enbrel-sucrose"^^xsd:anyURI ] ; ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-enbrel-sucrose> ) ] [ fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-enbrel-mannitol"^^xsd:anyURI ] ; ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-enbrel-mannitol> ) ] [ fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-enbrel-etanercept"^^xsd:anyURI ] ; ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-enbrel-etanercept> ) ] [ fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-enbrel-tromethamine"^^xsd:anyURI ] ; ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-enbrel-tromethamine> ) ] [ fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-etanercept"^^xsd:anyURI ] ; ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-etanercept> ) ] [ fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-7f657b63823319aa7da7d2c5939e39e5"^^xsd:anyURI ] ; ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-7f657b63823319aa7da7d2c5939e39e5> ) ] [ fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization7f657b63823319aa7da7d2c5939e39e50"^^xsd:anyURI ] ; ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization7f657b63823319aa7da7d2c5939e39e50> ) ] [ fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-9800de324c3962f6f767647a95e0c17e"^^xsd:anyURI ] ; ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-9800de324c3962f6f767647a95e0c17e> ) ] [ fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-51ddf55f89e2cd74ee3392c14c809976"^^xsd:anyURI ] ; ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-51ddf55f89e2cd74ee3392c14c809976> ) ] [ fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mp25bbfa948f4a0b224f9baa1fe481efa8"^^xsd:anyURI ] ; ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mp25bbfa948f4a0b224f9baa1fe481efa8> ) ] [ fhir:fullUrl [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-7f657b63823319aa7da7d2c5939e39e5"^^xsd:anyURI ] ; ( fhir:resource <http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-7f657b63823319aa7da7d2c5939e39e5> ) ] ) . # <http://hl7.eu/fhir/ig/gravitate-health/Composition/composition-en-25bbfa948f4a0b224f9baa1fe481efa8> a fhir:Composition ; fhir:id [ fhir:v "composition-en-25bbfa948f4a0b224f9baa1fe481efa8"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><a name=\"Composition_composition-en-25bbfa948f4a0b224f9baa1fe481efa8\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-25bbfa948f4a0b224f9baa1fe481efa8</b></p><a name=\"composition-en-25bbfa948f4a0b224f9baa1fe481efa8\"> </a><a name=\"hccomposition-en-25bbfa948f4a0b224f9baa1fe481efa8\"> </a><a name=\"composition-en-25bbfa948f4a0b224f9baa1fe481efa8-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: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/rmswi/</code>/50d2abb4441275478b3d10432498aec6</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi/ 100000155538}\">Package Leaflet</span></p><p><b>category</b>: <span title=\"Codes:{http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs R}\">Raw</span></p><p><b>date</b>: 2022-02-16 13:28:17+0000</p><p><b>author</b>: <a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#Organization_mah-9800de324c3962f6f767647a95e0c17e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>title</b>: TEST PURPOSES ONLY - Enbrel 25 mg powder for solution for injection</p><h3>Attesters</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/composition-attestation-mode official}\">Official</span></td><td>2022-02-16 13:28:17+0000</td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:value [ fhir:v "50d2abb4441275478b3d10432498aec6" ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "Package Leaflet" ] ] ; # fhir:category ( [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs"^^xsd:anyURI ] ; fhir:code [ fhir:v "R" ] ; fhir:display [ fhir:v "Raw" ] ] ) ] ) ; # fhir:subject ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/mp25bbfa948f4a0b224f9baa1fe481efa8" ] ] ) ; # fhir:date [ fhir:v "2022-02-16T13:28:17Z"^^xsd:dateTime] ; # fhir:author ( [ fhir:reference [ fhir:v "Organization/mah-9800de324c3962f6f767647a95e0c17e" ] ] ) ; # fhir:title [ fhir:v "TEST PURPOSES ONLY - Enbrel 25 mg powder for solution for injection"] ; # fhir:attester ( [ fhir:mode [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/composition-attestation-mode"^^xsd:anyURI ] ; fhir:code [ fhir:v "official" ] ] ) ] ; fhir:time [ fhir:v "2022-02-16T13:28:17Z"^^xsd:dateTime ] ] ) ; # fhir:section ( [ fhir:title [ fhir:v "B. Package Leaflet" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "B. Package Leaflet" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>" ] ; fhir:emptyReason [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ; fhir:code [ fhir:v "unavailable" ] ] ) ] ; ( fhir:section [ fhir:title [ fhir:v "Package leaflet: Information for the user" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "Package leaflet: Information for the user" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>" ] ; fhir:emptyReason [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ; fhir:code [ fhir:v "unavailable" ] ] ) ] ] [ fhir:title [ fhir:v "What is in this leaflet" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "What is in this leaflet" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>" ] ; fhir:emptyReason [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ; fhir:code [ fhir:v "unavailable" ] ] ) ] ] [ fhir:title [ fhir:v "1. What Enbrel 25 mg powder for solution for injection is and what it is used for" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "1. What Enbrel 25 mg powder for solution for injection is and what it is used for" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>" ] ; fhir:emptyReason [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ; fhir:code [ fhir:v "unavailable" ] ] ) ] ] [ fhir:title [ fhir:v "2. What you need to know before you take Enbrel 25 mg powder for solution for injection" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "2. What you need to know before you take Enbrel 25 mg powder for solution for injection" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>" ] ; fhir:emptyReason [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ; fhir:code [ fhir:v "unavailable" ] ] ) ] ] [ fhir:title [ fhir:v "3. How to take Enbrel 25 mg powder for solution for injection" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "3. How to take Enbrel 25 mg powder for solution for injection" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>" ] ; fhir:emptyReason [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ; fhir:code [ fhir:v "unavailable" ] ] ) ] ] [ fhir:title [ fhir:v "4. Possible side effects" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "4. Possible side effects" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>" ] ; fhir:emptyReason [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ; fhir:code [ fhir:v "unavailable" ] ] ) ] ] [ fhir:title [ fhir:v "5. How to store Enbrel 25 mg powder for solution for injection" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "5. How to store Enbrel 25 mg powder for solution for injection" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>" ] ; fhir:emptyReason [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ; fhir:code [ fhir:v "unavailable" ] ] ) ] ] [ fhir:title [ fhir:v "6. Contents of the pack and other information" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "6. Contents of the pack and other information" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>" ] ; fhir:emptyReason [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ; fhir:code [ fhir:v "unavailable" ] ] ) ] ] ) ] ) . # <http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-enbrel-sucrose> a fhir:Ingredient ; fhir:id [ fhir:v "ingredient-for-enbrel-sucrose"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-enbrel-sucrose\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-for-enbrel-sucrose</b></p><a name=\"ingredient-for-enbrel-sucrose\"> </a><a name=\"hcingredient-for-enbrel-sucrose\"> </a><a name=\"ingredient-for-enbrel-sucrose-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/C151H8M554 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#ManufacturedItemDefinition_mid-7f657b63823319aa7da7d2c5939e39e5\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#MedicinalProductDefinition_mp25bbfa948f4a0b224f9baa1fe481efa8\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#AdministrableProductDefinition_ap-7f657b63823319aa7da7d2c5939e39e5\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072082}\">Excipient</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:{https://gsrs.ncats.nih.gov/ginas/app/beta C151H8M554}\">SUCROSE</span></td></tr></table></blockquote></div>" ] ; # fhir:identifier [ fhir:use [ fhir:v "official" ] ; fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ; fhir:value [ fhir:v "C151H8M554" ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:for ( [ fhir:reference [ fhir:v "ManufacturedItemDefinition/mid-7f657b63823319aa7da7d2c5939e39e5" ] ] [ fhir:reference [ fhir:v "MedicinalProductDefinition/mp25bbfa948f4a0b224f9baa1fe481efa8" ] ] [ fhir:reference [ fhir:v "AdministrableProductDefinition/ap-7f657b63823319aa7da7d2c5939e39e5" ] ] ) ; # fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000072082" ] ; fhir:display [ fhir:v "Excipient" ] ] ) ] ; # fhir:substance [ fhir:code [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ; fhir:code [ fhir:v "C151H8M554" ] ; fhir:display [ fhir:v "SUCROSE" ] ] ) ] ] ] . # <http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-enbrel-mannitol> a fhir:Ingredient ; fhir:id [ fhir:v "ingredient-for-enbrel-mannitol"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-enbrel-mannitol\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-for-enbrel-mannitol</b></p><a name=\"ingredient-for-enbrel-mannitol\"> </a><a name=\"hcingredient-for-enbrel-mannitol\"> </a><a name=\"ingredient-for-enbrel-mannitol-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/3OWL53L36A (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#ManufacturedItemDefinition_mid-7f657b63823319aa7da7d2c5939e39e5\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#MedicinalProductDefinition_mp25bbfa948f4a0b224f9baa1fe481efa8\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#AdministrableProductDefinition_ap-7f657b63823319aa7da7d2c5939e39e5\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072082}\">Excipient</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:{https://gsrs.ncats.nih.gov/ginas/app/beta 3OWL53L36A}\">MANNITOL</span></td></tr></table></blockquote></div>" ] ; # fhir:identifier [ fhir:use [ fhir:v "official" ] ; fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ; fhir:value [ fhir:v "3OWL53L36A" ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:for ( [ fhir:reference [ fhir:v "ManufacturedItemDefinition/mid-7f657b63823319aa7da7d2c5939e39e5" ] ] [ fhir:reference [ fhir:v "MedicinalProductDefinition/mp25bbfa948f4a0b224f9baa1fe481efa8" ] ] [ fhir:reference [ fhir:v "AdministrableProductDefinition/ap-7f657b63823319aa7da7d2c5939e39e5" ] ] ) ; # fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000072082" ] ; fhir:display [ fhir:v "Excipient" ] ] ) ] ; # fhir:substance [ fhir:code [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ; fhir:code [ fhir:v "3OWL53L36A" ] ; fhir:display [ fhir:v "MANNITOL" ] ] ) ] ] ] . # <http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-enbrel-etanercept> a fhir:Ingredient ; fhir:id [ fhir:v "ingredient-for-enbrel-etanercept"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-enbrel-etanercept\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-for-enbrel-etanercept</b></p><a name=\"ingredient-for-enbrel-etanercept\"> </a><a name=\"hcingredient-for-enbrel-etanercept\"> </a><a name=\"ingredient-for-enbrel-etanercept-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/OP401G7OJC (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#ManufacturedItemDefinition_mid-7f657b63823319aa7da7d2c5939e39e5\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#MedicinalProductDefinition_mp25bbfa948f4a0b224f9baa1fe481efa8\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#AdministrableProductDefinition_ap-7f657b63823319aa7da7d2c5939e39e5\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072072}\">Active</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:{https://gsrs.ncats.nih.gov/ginas/app/beta OP401G7OJC}\">Etanercept</span></td></tr></table><h3>Strengths</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style=\"display: none\">*</td><td>25 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span></td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}\">active ingredient - basis of strength</span></td></tr></table></blockquote></div>" ] ; # fhir:identifier [ fhir:use [ fhir:v "official" ] ; fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ; fhir:value [ fhir:v "OP401G7OJC" ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:for ( [ fhir:reference [ fhir:v "ManufacturedItemDefinition/mid-7f657b63823319aa7da7d2c5939e39e5" ] ] [ fhir:reference [ fhir:v "MedicinalProductDefinition/mp25bbfa948f4a0b224f9baa1fe481efa8" ] ] [ fhir:reference [ fhir:v "AdministrableProductDefinition/ap-7f657b63823319aa7da7d2c5939e39e5" ] ] ) ; # fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000072072" ] ; fhir:display [ fhir:v "Active" ] ] ) ] ; # fhir:substance [ fhir:code [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ; fhir:code [ fhir:v "OP401G7OJC" ] ; fhir:display [ fhir:v "Etanercept" ] ] ) ] ] ; ( fhir:strength [ fhir:presentation [ a fhir:Quantity ; fhir:value [ fhir:v "25"^^xsd:decimal ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mg" ] ] ; fhir:basis [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v3-RoleClass"^^xsd:anyURI ] ; fhir:code [ fhir:v "ACTIB" ] ; fhir:display [ fhir:v "active ingredient - basis of strength" ] ] ) ] ] ) ] . # <http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-enbrel-tromethamine> a fhir:Ingredient ; fhir:id [ fhir:v "ingredient-for-enbrel-tromethamine"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-enbrel-tromethamine\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-for-enbrel-tromethamine</b></p><a name=\"ingredient-for-enbrel-tromethamine\"> </a><a name=\"hcingredient-for-enbrel-tromethamine\"> </a><a name=\"ingredient-for-enbrel-tromethamine-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/023C2WHX2V (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#ManufacturedItemDefinition_mid-7f657b63823319aa7da7d2c5939e39e5\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#MedicinalProductDefinition_mp25bbfa948f4a0b224f9baa1fe481efa8\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#AdministrableProductDefinition_ap-7f657b63823319aa7da7d2c5939e39e5\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072082}\">Excipient</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:{https://gsrs.ncats.nih.gov/ginas/app/beta 023C2WHX2V}\">TROMETHAMINE</span></td></tr></table></blockquote></div>" ] ; # fhir:identifier [ fhir:use [ fhir:v "official" ] ; fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ; fhir:value [ fhir:v "023C2WHX2V" ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:for ( [ fhir:reference [ fhir:v "ManufacturedItemDefinition/mid-7f657b63823319aa7da7d2c5939e39e5" ] ] [ fhir:reference [ fhir:v "MedicinalProductDefinition/mp25bbfa948f4a0b224f9baa1fe481efa8" ] ] [ fhir:reference [ fhir:v "AdministrableProductDefinition/ap-7f657b63823319aa7da7d2c5939e39e5" ] ] ) ; # fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000072082" ] ; fhir:display [ fhir:v "Excipient" ] ] ) ] ; # fhir:substance [ fhir:code [ fhir:concept [ ( fhir:coding [ fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ; fhir:code [ fhir:v "023C2WHX2V" ] ; fhir:display [ fhir:v "TROMETHAMINE" ] ] ) ] ] ] . # <http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-etanercept> a fhir:SubstanceDefinition ; fhir:id [ fhir:v "substance-etanercept"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_substance-etanercept\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition substance-etanercept</b></p><a name=\"substance-etanercept\"> </a><a name=\"hcsubstance-etanercept\"> </a><a name=\"substance-etanercept-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/OP401G7OJC (use: official, )</p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>manufacturer</b>: <a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#Organization_mah-9800de324c3962f6f767647a95e0c17e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>" ] ; # fhir:identifier ( [ fhir:use [ fhir:v "official" ] ; fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta/"^^xsd:anyURI ] ; fhir:value [ fhir:v "OP401G7OJC" ] ] ) ; # fhir:status [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ; fhir:code [ fhir:v "active" ] ] ) ] ; # fhir:manufacturer ( [ fhir:reference [ fhir:v "Organization/mah-9800de324c3962f6f767647a95e0c17e" ] ] ) . # <http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-7f657b63823319aa7da7d2c5939e39e5> a fhir:AdministrableProductDefinition ; fhir:id [ fhir:v "ap-7f657b63823319aa7da7d2c5939e39e5"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"AdministrableProductDefinition_ap-7f657b63823319aa7da7d2c5939e39e5\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition ap-7f657b63823319aa7da7d2c5939e39e5</b></p><a name=\"ap-7f657b63823319aa7da7d2c5939e39e5\"> </a><a name=\"hcap-7f657b63823319aa7da7d2c5939e39e5\"> </a><a name=\"ap-7f657b63823319aa7da7d2c5939e39e5-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/id</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#MedicinalProductDefinition_mp25bbfa948f4a0b224f9baa1fe481efa8\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>administrableDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073866}\">Powder for solution for injection</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000002158}\">Vial</span></p><p><b>producedFrom</b>: <a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#ManufacturedItemDefinition_mid-7f657b63823319aa7da7d2c5939e39e5\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073633}\">Subcutaneous use</span></p><h3>TargetSpecies</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:{https://spor.ema.europa.eu/rmswi 100000109093}\">Human</span></td></tr></table></blockquote></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "https://spor.ema.europa.eu/pmswi"^^xsd:anyURI ] ; fhir:value [ fhir:v "id" ] ] ) ; # fhir:status [ fhir:v "active"] ; # fhir:formOf ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/mp25bbfa948f4a0b224f9baa1fe481efa8" ] ] ) ; # fhir:administrableDoseForm [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000073866" ] ; fhir:display [ fhir:v "Powder for solution for injection" ] ] ) ] ; # fhir:unitOfPresentation [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000002158" ] ; fhir:display [ fhir:v "Vial" ] ] ) ] ; # fhir:producedFrom ( [ fhir:reference [ fhir:v "ManufacturedItemDefinition/mid-7f657b63823319aa7da7d2c5939e39e5" ] ] ) ; # fhir:routeOfAdministration ( [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000073633" ] ; fhir:display [ fhir:v "Subcutaneous use" ] ] ) ] ; ( fhir:targetSpecies [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000109093" ] ; fhir:display [ fhir:v "Human" ] ] ) ] ] ) ] ) . # <http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization7f657b63823319aa7da7d2c5939e39e50> a fhir:RegulatedAuthorization ; fhir:id [ fhir:v "authorization7f657b63823319aa7da7d2c5939e39e50"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_authorization7f657b63823319aa7da7d2c5939e39e50\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization authorization7f657b63823319aa7da7d2c5939e39e50</b></p><a name=\"authorization7f657b63823319aa7da7d2c5939e39e50\"> </a><a name=\"hcauthorization7f657b63823319aa7da7d2c5939e39e50\"> </a><a name=\"authorization7f657b63823319aa7da7d2c5939e39e50-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/99/126/003 (use: official, )</p><p><b>subject</b>: <a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#MedicinalProductDefinition_mp25bbfa948f4a0b224f9baa1fe481efa8\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 220000000061}\">Marketing Authorisation</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>statusDate</b>: 2009-11-26 13:28:17+0000</p><p><b>holder</b>: <a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#Organization_mah-9800de324c3962f6f767647a95e0c17e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>" ] ; # fhir:identifier ( [ fhir:use [ fhir:v "official" ] ; fhir:system [ fhir:v "https://spor.ema.europa.eu/pmswi"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU/1/99/126/003" ] ] ) ; # fhir:subject ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/mp25bbfa948f4a0b224f9baa1fe481efa8" ] ] ) ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000061" ] ; fhir:display [ fhir:v "Marketing Authorisation" ] ] ) ] ; # fhir:status [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ; fhir:code [ fhir:v "active" ] ; fhir:display [ fhir:v "Active" ] ] ) ] ; # fhir:statusDate [ fhir:v "2009-11-26T13:28:17Z"^^xsd:dateTime] ; # fhir:holder [ fhir:reference [ fhir:v "Organization/mah-9800de324c3962f6f767647a95e0c17e" ] ] . # <http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-9800de324c3962f6f767647a95e0c17e> a fhir:Organization ; fhir:id [ fhir:v "mah-9800de324c3962f6f767647a95e0c17e"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_mah-9800de324c3962f6f767647a95e0c17e\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization mah-9800de324c3962f6f767647a95e0c17e</b></p><a name=\"mah-9800de324c3962f6f767647a95e0c17e\"> </a><a name=\"hcmah-9800de324c3962f6f767647a95e0c17e\"> </a><a name=\"mah-9800de324c3962f6f767647a95e0c17e-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/ORG-100011459 (use: official, )</p><p><b>active</b>: true</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 220000000034}\">Marketing authorisation holder</span></p><p><b>name</b>: Pfizer Europe MA EEIG</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Boulevard de la Plaine 17,1050 Bruxelles Bruxelles BE(work)</td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:use [ fhir:v "official" ] ; fhir:system [ fhir:v "https://spor.ema.europa.eu/omswi"^^xsd:anyURI ] ; fhir:value [ fhir:v "ORG-100011459" ] ] ) ; # fhir:active [ fhir:v "true"^^xsd:boolean] ; # fhir:type ( [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000034" ] ; fhir:display [ fhir:v "Marketing authorisation holder" ] ] ) ] ) ; # fhir:name [ fhir:v "Pfizer Europe MA EEIG"] ; # fhir:contact ( [ fhir:address [ fhir:use [ fhir:v "work" ] ; fhir:type [ fhir:v "physical" ] ; fhir:text [ fhir:v "Boulevard de la Plaine 17,1050 Bruxelles Bruxelles BE" ] ; ( fhir:line [ fhir:v "Boulevard de la Plaine 17,1050 Bruxelles" ] ) ; fhir:city [ fhir:v "Bruxelles" ] ; fhir:country [ fhir:v "BE" ] ] ] ) . # <http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-51ddf55f89e2cd74ee3392c14c809976> a fhir:PackagedProductDefinition ; fhir:id [ fhir:v "ppd-51ddf55f89e2cd74ee3392c14c809976"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_ppd-51ddf55f89e2cd74ee3392c14c809976\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition ppd-51ddf55f89e2cd74ee3392c14c809976</b></p><a name=\"ppd-51ddf55f89e2cd74ee3392c14c809976\"> </a><a name=\"hcppd-51ddf55f89e2cd74ee3392c14c809976\"> </a><a name=\"ppd-51ddf55f89e2cd74ee3392c14c809976-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/99/126/003 (use: official, )</p><p><b>name</b>: Enbrel 25 mg powder for solution for injection 28</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000155527}\">Chemical Medicinal Product</span></p><p><b>packageFor</b>: <a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#MedicinalProductDefinition_mp25bbfa948f4a0b224f9baa1fe481efa8\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>statusDate</b>: 2015-02-07 13:28:17+0000</p><p><b>containedItemQuantity</b>: 25 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073498}\">Box</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000003529}\">Cardboard</span></p><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/123456</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073496}\">Blister</span></p><p><b>quantity</b>: 28</p><p><b>material</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000003222}\">PolyVinyl Chloride</span></p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#ManufacturedItemDefinition_mid-7f657b63823319aa7da7d2c5939e39e5\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></td></tr></table></blockquote></blockquote></blockquote></div>" ] ; # fhir:identifier ( [ fhir:use [ fhir:v "official" ] ; fhir:system [ fhir:v "https://spor.ema.europa.eu/pmswi"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU/1/99/126/003" ] ] ) ; # fhir:name [ fhir:v "Enbrel 25 mg powder for solution for injection 28"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155527" ] ; fhir:display [ fhir:v "Chemical Medicinal Product" ] ] ) ] ; # fhir:packageFor ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/mp25bbfa948f4a0b224f9baa1fe481efa8" ] ] ) ; # fhir:status [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ; fhir:code [ fhir:v "active" ] ; fhir:display [ fhir:v "Active" ] ] ) ] ; # fhir:statusDate [ fhir:v "2015-02-07T13:28:17Z"^^xsd:dateTime] ; # fhir:containedItemQuantity ( [ fhir:value [ fhir:v "25"^^xsd:decimal ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "mg" ] ] ) ; # fhir:packaging [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000073498" ] ; fhir:display [ fhir:v "Box" ] ] ) ] ; fhir:quantity [ fhir:v "1"^^xsd:integer ] ; ( fhir:material [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000003529" ] ; fhir:display [ fhir:v "Cardboard" ] ] ) ] ) ; ( fhir:packaging [ ( fhir:identifier [ fhir:system [ fhir:v "https://spor.ema.europa.eu/pmswi"^^xsd:anyURI ] ; fhir:value [ fhir:v "123456" ] ] ) ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000073496" ] ; fhir:display [ fhir:v "Blister" ] ] ) ] ; fhir:quantity [ fhir:v "28"^^xsd:integer ] ; ( fhir:material [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000003222" ] ; fhir:display [ fhir:v "PolyVinyl Chloride" ] ] ) ] ) ; ( fhir:containedItem [ fhir:item [ fhir:reference [ fhir:reference [ fhir:v "ManufacturedItemDefinition/mid-7f657b63823319aa7da7d2c5939e39e5" ] ] ] ] ) ] ) ] . # <http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mp25bbfa948f4a0b224f9baa1fe481efa8> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "mp25bbfa948f4a0b224f9baa1fe481efa8"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mp25bbfa948f4a0b224f9baa1fe481efa8\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mp25bbfa948f4a0b224f9baa1fe481efa8</b></p><a name=\"mp25bbfa948f4a0b224f9baa1fe481efa8\"> </a><a name=\"hcmp25bbfa948f4a0b224f9baa1fe481efa8\"> </a><a name=\"mp25bbfa948f4a0b224f9baa1fe481efa8-en-US\"> </a><p><b>identifier</b>: <code>http://fakesys.com/ids</code>/zz</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}\">Medicinal Product</span></p><p><b>domain</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-domain Human}\">Human use</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">active</span></p><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072084}\">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Enbrel 25 mg powder for solution for injection</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}\">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: Enbrel</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: Etanercept</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}\">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 25 mg</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: powder for solution for injection</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}\">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 NOR}\">Norway</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 NOR}\">Norway</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 en}\">English</span></td></tr></table></blockquote></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://fakesys.com/ids"^^xsd:anyURI ] ; fhir:value [ fhir:v "zz" ] ] ) ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "MedicinalProduct" ] ; fhir:display [ fhir:v "Medicinal Product" ] ] ) ] ; # fhir:domain [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-domain"^^xsd:anyURI ] ; fhir:code [ fhir:v "Human" ] ; fhir:display [ fhir:v "Human use" ] ] ) ] ; # fhir:status [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ; fhir:code [ fhir:v "active" ] ; fhir:display [ fhir:v "active" ] ] ) ] ; # fhir:legalStatusOfSupply [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000072084" ] ; fhir:display [ fhir:v "Medicinal product subject to medical prescription" ] ] ) ] ; # fhir:name ( [ fhir:productName [ fhir:v "Enbrel 25 mg powder for solution for injection" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000001" ] ; fhir:display [ fhir:v "Full name" ] ] ) ] ; ( fhir:part [ fhir:part [ fhir:v "Enbrel" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000002" ] ; fhir:display [ fhir:v "Invented name part" ] ] ) ] ] [ fhir:part [ fhir:v "Etanercept" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000003" ] ; fhir:display [ fhir:v "Scientific name part" ] ] ) ] ] [ fhir:part [ fhir:v "25 mg" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000004" ] ; fhir:display [ fhir:v "Strength part" ] ] ) ] ] [ fhir:part [ fhir:v "powder for solution for injection" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000005" ] ; fhir:display [ fhir:v "Pharmaceutical dose form part" ] ] ) ] ] ) ; ( fhir:usage [ fhir:country [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "NOR" ] ; fhir:display [ fhir:v "Norway" ] ] ) ] ; fhir:jurisdiction [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "NOR" ] ; fhir:display [ fhir:v "Norway" ] ] ) ] ; fhir:language [ ( fhir:coding [ fhir:system [ fhir:v "urn:ietf:bcp:47"^^xsd:anyURI ] ; fhir:code [ fhir:v "en" ] ; fhir:display [ fhir:v "English" ] ] ) ] ] ) ] ) . # <http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-7f657b63823319aa7da7d2c5939e39e5> a fhir:ManufacturedItemDefinition ; fhir:id [ fhir:v "mid-7f657b63823319aa7da7d2c5939e39e5"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ManufacturedItemDefinition_mid-7f657b63823319aa7da7d2c5939e39e5\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition mid-7f657b63823319aa7da7d2c5939e39e5</b></p><a name=\"mid-7f657b63823319aa7da7d2c5939e39e5\"> </a><a name=\"hcmid-7f657b63823319aa7da7d2c5939e39e5\"> </a><a name=\"mid-7f657b63823319aa7da7d2c5939e39e5-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/99/126/003 (use: official, )</p><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi/ 100000073866}\">Powder for solution for injection</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000002158}\">Vial</span></p></div>" ] ; # fhir:identifier ( [ fhir:use [ fhir:v "official" ] ; fhir:system [ fhir:v "https://spor.ema.europa.eu/pmswi"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU/1/99/126/003" ] ] ) ; # fhir:status [ fhir:v "active"] ; # fhir:manufacturedDoseForm [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000073866" ] ; fhir:display [ fhir:v "Powder for solution for injection" ] ] ) ] ; # fhir:unitOfPresentation [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000002158" ] ; fhir:display [ fhir:v "Vial" ] ] ) ] . #
IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.gh#0.1.0 based on FHIR 5.0.0. Generated 2024-12-20
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.