UFIS-SWE-IG
0.1.0 - ci-build
UFIS-SWE-IG
0.1.0 - ci-build
UFIS-SWE-IG, published by UNICOM. 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/joofio/ufis-swe-ig/ and changes regularly. See the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_SimvastatinBluefish-20mg-Tablet-SE-BS-MPD"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition SimvastatinBluefish-20mg-Tablet-SE-BS-MPD</b></p><a name="SimvastatinBluefish-20mg-Tablet-SE-BS-MPD"> </a><a name="hcSimvastatinBluefish-20mg-Tablet-SE-BS-MPD"> </a><a name="hcSimvastatinBluefish-20mg-Tablet-SE-BS-MPD-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/mpId</code>/SE-100002566-00026678, <code>http://ema.europa.eu/fhir/eurdId</code>/2709</p><p><b>domain</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000004 100000000012}">Human use</span></p><p><b>status</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000005003 200000005004}">Current</span></p><p><b>combinedPharmaceuticalDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004~200000000006~200000000007~200000000008 100000073665}">Film-coated tablet</span></p><p><b>indication</b>: </p><div><p>Hypercholesterolaemia Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (such as exercise, weight reduction) is inadequate. Treatment of homozygous familial hypercholesterolaemia (HoFH) as an adjunct to diet and other lipid-lowering treatments (e.g. LDL-apheresis) or if such treatments are not appropriate. Cardiovascular prevention Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy (see section 5.1).</p>
</div><p><b>legalStatusOfSupply</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072051 100000072084}">Medicinal product subject to medical prescription</span></p><p><b>classification</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000093533 100000095169}">simvastatin</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Simvastatin Bluefish 20 mg filmdragerad tablett</p><blockquote><p><b>part</b></p><p><b>part</b>: SimvastatinBluefish</p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000003}">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 20 mg</p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000004}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: Filmdragerad tablett</p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/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>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000535}">Kingdom of Sweden</span></td><td><span title="Codes:{urn:ietf:bcp:47 sv}">Swedish</span></td></tr></table></blockquote></div>
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<code value="100000073665"/>
<display value="Film-coated tablet"/>
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<indication
value="Hypercholesterolaemia Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (such as exercise, weight reduction) is inadequate. Treatment of homozygous familial hypercholesterolaemia (HoFH) as an adjunct to diet and other lipid-lowering treatments (e.g. LDL-apheresis) or if such treatments are not appropriate. Cardiovascular prevention Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy (see section 5.1)."/>
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<classification>
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<name>
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value="Simvastatin Bluefish 20 mg filmdragerad tablett"/>
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<display value="Pharmaceutical dose form part"/>
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<code value="sv"/>
<display value="Swedish"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_SimvastatinBluefish-20mg-Tablet-SE-BS-RA"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization SimvastatinBluefish-20mg-Tablet-SE-BS-RA</b></p><a name="SimvastatinBluefish-20mg-Tablet-SE-BS-RA"> </a><a name="hcSimvastatinBluefish-20mg-Tablet-SE-BS-RA"> </a><a name="hcSimvastatinBluefish-20mg-Tablet-SE-BS-RA-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/marketingAuthorizationNumber</code>/26678</p><p><b>subject</b>: <a href="MedicinalProductDefinition-SimvastatinBluefish-20mg-Tablet-SE-BS-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100002566-00026678,http://ema.europa.eu/fhir/eurdId#2709; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; indication = Hypercholesterolaemia Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (such as exercise, weight reduction) is inadequate. Treatment of homozygous familial hypercholesterolaemia (HoFH) as an adjunct to diet and other lipid-lowering treatments (e.g. LDL-apheresis) or if such treatments are not appropriate. Cardiovascular prevention Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy (see section 5.1).; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = simvastatin</a></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/220000000060 220000000061}">Marketing Authorisation</span></p><p><b>region</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000535}">Kingdom of Sweden</span></p><p><b>status</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072049 100000072099}">Valid</span></p><p><b>statusDate</b>: 2008-10-31</p><p><b>holder</b>: <a href="Organization-LOC-100007939.html">Organization Bluefish Pharmaceuticals</a></p><h3>Cases</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Date[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://ema.europa.eu/fhir/authorisationDateType dateOfFirstAuthorisation}">First Authorisation</span></td><td>2008-10-31</td></tr></table></div>
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<system value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
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<display value="Kingdom of Sweden"/>
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<code value="100000072099"/>
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<holder>🔗
<reference value="Organization/LOC-100007939"/>
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<case>
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<entry>
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value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/PackagedProductDefinition/SimvastatinBluefish-20mg-Tablet-SE-BS-PPD"/>
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<id value="SimvastatinBluefish-20mg-Tablet-SE-BS-PPD"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_SimvastatinBluefish-20mg-Tablet-SE-BS-PPD"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition SimvastatinBluefish-20mg-Tablet-SE-BS-PPD</b></p><a name="SimvastatinBluefish-20mg-Tablet-SE-BS-PPD"> </a><a name="hcSimvastatinBluefish-20mg-Tablet-SE-BS-PPD"> </a><a name="hcSimvastatinBluefish-20mg-Tablet-SE-BS-PPD-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/example/pcid</code>/?ngen-9?</p><p><b>packageFor</b>: <a href="MedicinalProductDefinition-SimvastatinBluefish-20mg-Tablet-SE-BS-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100002566-00026678,http://ema.europa.eu/fhir/eurdId#2709; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; indication = Hypercholesterolaemia Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (such as exercise, weight reduction) is inadequate. Treatment of homozygous familial hypercholesterolaemia (HoFH) as an adjunct to diet and other lipid-lowering treatments (e.g. LDL-apheresis) or if such treatments are not appropriate. Cardiovascular prevention Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy (see section 5.1).; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = simvastatin</a></p><p><b>containedItemQuantity</b>: 100 Tablet<span style="background: LightGoldenRodYellow"> (Details: 200000000014 code200000002152 = '200000002152')</span></p><p><b>description</b>: </p><div><p>Blister, 100 tablet</p>
</div><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Status</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000535}">Kingdom of Sweden</span></td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072052 100000072083}">Marketed</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073498}">Box</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003529}">Cardboard</span></p><blockquote><p><b>packaging</b></p></blockquote></blockquote></div>
</text>
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<packageFor>🔗
<reference
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<containedItemQuantity>
<value value="100"/>
<unit value="Tablet"/>
<system value="http://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
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<description value="Blister, 100 tablet"/>
<marketingStatus>
<country>
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<code value="100000000535"/>
<display value="Kingdom of Sweden"/>
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<code value="100000072083"/>
<display value="Marketed"/>
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<packaging>
<type>
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<code value="100000073498"/>
<display value="Box"/>
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<quantity value="1"/>
<material>
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<code value="200000003529"/>
<display value="Cardboard"/>
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<packaging>
<type>
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<system
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<code value="100000073496"/>
<display value="Blister"/>
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<quantity value="10"/>
<material>
<coding>
<system
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<code value="200000003200"/>
<display value="Aluminium"/>
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<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/SimvastatinBluefish-20mg-Tablet-SE-BS-MID"/>
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</item>
<amount>
<value value="10"/>
<unit value="Tablet"/>
<system
value="http://spor.ema.europa.eu/v1/lists/100000110633~200000000014"/>
<code value="200000002152"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_SimvastatinBluefish-20mg-Tablet-SE-BS-MID"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition SimvastatinBluefish-20mg-Tablet-SE-BS-MID</b></p><a name="SimvastatinBluefish-20mg-Tablet-SE-BS-MID"> </a><a name="hcSimvastatinBluefish-20mg-Tablet-SE-BS-MID"> </a><a name="hcSimvastatinBluefish-20mg-Tablet-SE-BS-MID-en-US"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073665}">Film-coated tablet</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000014 200000002152}">Tablet</span></p></div>
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<status value="active"/>
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<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073665"/>
<display value="Film-coated tablet"/>
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<display value="Tablet"/>
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<entry>
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<resource>
<Ingredient>
<id value="SimvastatinBluefish-20mg-Tablet-SE-BS-ING"/>
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<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_SimvastatinBluefish-20mg-Tablet-SE-BS-ING"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient SimvastatinBluefish-20mg-Tablet-SE-BS-ING</b></p><a name="SimvastatinBluefish-20mg-Tablet-SE-BS-ING"> </a><a name="hcSimvastatinBluefish-20mg-Tablet-SE-BS-ING"> </a><a name="hcSimvastatinBluefish-20mg-Tablet-SE-BS-ING-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="MedicinalProductDefinition-SimvastatinBluefish-20mg-Tablet-SE-BS-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100002566-00026678,http://ema.europa.eu/fhir/eurdId#2709; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; indication = Hypercholesterolaemia Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (such as exercise, weight reduction) is inadequate. Treatment of homozygous familial hypercholesterolaemia (HoFH) as an adjunct to diet and other lipid-lowering treatments (e.g. LDL-apheresis) or if such treatments are not appropriate. Cardiovascular prevention Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy (see section 5.1).; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = simvastatin</a></li><li><a href="ManufacturedItemDefinition-SimvastatinBluefish-20mg-Tablet-SE-BS-MID.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href="AdministrableProductDefinition-SimvastatinBluefish-20mg-Tablet-SE-BS-APD.html">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072050 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://spor.azure-api.net/sms/api/v2/SubstanceDefinition 100000091786}">Simvastatin</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>presentation</b>: 20 milligram(s)<span style="background: LightGoldenRodYellow"> (Details: 100000110633 code100000110655 = '100000110655')</span>/1 tablet<span style="background: LightGoldenRodYellow"> (Details: 200000000014 code200000002152 = '200000002152')</span></p><blockquote><p><b>referenceStrength</b></p><h3>Substances</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://spor.azure-api.net/sms/api/v2/SubstanceDefinition 100000091786}">Simvastatin</span></td></tr></table><p><b>strength</b>: 20 milligram(s)<span style="background: LightGoldenRodYellow"> (Details: Unit of Measurement EMA code100000110655 = 'milligram(s)')</span>/1 tablet<span style="background: LightGoldenRodYellow"> (Details: 200000000014 code200000002152 = '200000002152')</span></p></blockquote></blockquote></blockquote></div>
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<status value="active"/>
<for>🔗
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<for>🔗
<reference
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</for>
<for>🔗
<reference
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<code value="100000091786"/>
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<strength>
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<unit value="milligram(s)"/>
<system
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<code value="100000110655"/>
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<system
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<code value="200000002152"/>
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<coding>
<system
value="https://spor.azure-api.net/sms/api/v2/SubstanceDefinition"/>
<code value="100000091786"/>
<display value="Simvastatin"/>
</coding>
</concept>
</substance>
<strengthRatio>
<numerator>
<value value="20"/>
<unit value="milligram(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="tablet"/>
<system
value="http://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</denominator>
</strengthRatio>
</referenceStrength>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/AdministrableProductDefinition/SimvastatinBluefish-20mg-Tablet-SE-BS-APD"/>
<resource>
<AdministrableProductDefinition>
<id value="SimvastatinBluefish-20mg-Tablet-SE-BS-APD"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_SimvastatinBluefish-20mg-Tablet-SE-BS-APD"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition SimvastatinBluefish-20mg-Tablet-SE-BS-APD</b></p><a name="SimvastatinBluefish-20mg-Tablet-SE-BS-APD"> </a><a name="hcSimvastatinBluefish-20mg-Tablet-SE-BS-APD"> </a><a name="hcSimvastatinBluefish-20mg-Tablet-SE-BS-APD-en-US"> </a><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="MedicinalProductDefinition-SimvastatinBluefish-20mg-Tablet-SE-BS-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100002566-00026678,http://ema.europa.eu/fhir/eurdId#2709; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; indication = Hypercholesterolaemia Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (such as exercise, weight reduction) is inadequate. Treatment of homozygous familial hypercholesterolaemia (HoFH) as an adjunct to diet and other lipid-lowering treatments (e.g. LDL-apheresis) or if such treatments are not appropriate. Cardiovascular prevention Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy (see section 5.1).; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = simvastatin</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073665}">Film-coated tablet</span></p><p><b>producedFrom</b>: <a href="ManufacturedItemDefinition-SimvastatinBluefish-20mg-Tablet-SE-BS-MID.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></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:{https://spor.ema.europa.eu/v1/lists/100000073345 100000073619}">Oral use</span></td></tr></table></div>
</text>
<status value="active"/>
<formOf>🔗
<reference
value="MedicinalProductDefinition/SimvastatinBluefish-20mg-Tablet-SE-BS-MPD"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073665"/>
<display value="Film-coated tablet"/>
</coding>
</administrableDoseForm>
<producedFrom>🔗
<reference
value="ManufacturedItemDefinition/SimvastatinBluefish-20mg-Tablet-SE-BS-MID"/>
</producedFrom>
<routeOfAdministration>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073345"/>
<code value="100000073619"/>
<display value="Oral use"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Organization/LOC-100007939"/>
<resource>
<Organization>
<id value="LOC-100007939"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_LOC-100007939"> </a><p class="res-header-id"><b>Generated Narrative: Organization LOC-100007939</b></p><a name="LOC-100007939"> </a><a name="hcLOC-100007939"> </a><a name="hcLOC-100007939-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/v1/locations</code>/LOC-100007939</p><p><b>name</b>: Bluefish Pharmaceuticals</p></div>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<value value="LOC-100007939"/>
</identifier>
<name value="Bluefish Pharmaceuticals"/>
</Organization>
</resource>
</entry>
</Bundle>
IG © 2022+ UNICOM. Package hl7.eu.fhir.ufis-swe-unicom#0.1.0 based on FHIR 5.0.0. Generated 2024-06-28
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QA Report
The UNICOM Innovation Action has received funding from the European Union's Horizon 2020
research and innovation programme under grant agreement No. 875299.
