Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_Aprokam-50mg-Powder-SE-IS-MPD"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition Aprokam-50mg-Powder-SE-IS-MPD</b></p><a name="Aprokam-50mg-Powder-SE-IS-MPD"> </a><a name="hcAprokam-50mg-Powder-SE-IS-MPD"> </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">version: 1; Last updated: 2025-11-26 09:20:54+0000</p><p style="margin-bottom: 0px">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition</code></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/mpId</code>/SE-100001677-00046149, <code>http://ema.europa.eu/fhir/eurdId</code>/615</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 100000073866}">Powder for solution for injection</span></p><p><b>indication</b>: </p><div><p>Antibiotikaprofylax mot postoperativ endoftalmit efter kataraktoperation. Beakta de officiella riktlinjerna gÀllande korrekt anvÀndning av antibakteriella lÀkemedel, inkluderande riktlinjer för antibiotikaprofylax vid ögonkirurgi.</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/100000116677 100000093533}">S01AA27</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Aprokam 50 mg Pulver till injektionsvÀtska, lösning</p><blockquote><p><b>part</b></p><p><b>part</b>: Aprokam</p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000002}">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 50 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>: pulver till injektionsvÀtska, lösning</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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<value value="SE-100001677-00046149"/>
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<code value="100000073866"/>
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<indication
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<name>
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<part value="Aprokam"/>
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<code value="220000000002"/>
<display value="Invented name part"/>
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<part>
<part value="50 mg"/>
<type>
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<code value="220000000004"/>
<display value="Strength part"/>
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<part>
<part value="pulver till injektionsvÀtska, lösning"/>
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<display value="Pharmaceutical dose form part"/>
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<display value="Swedish"/>
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<id value="Aprokam-50mg-Powder-SE-IS-RA"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_Aprokam-50mg-Powder-SE-IS-RA"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization Aprokam-50mg-Powder-SE-IS-RA</b></p><a name="Aprokam-50mg-Powder-SE-IS-RA"> </a><a name="hcAprokam-50mg-Powder-SE-IS-RA"> </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">version: 1; Last updated: 2025-11-26 09:23:04+0000</p><p style="margin-bottom: 0px">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLRegulatedAuthorization</code></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/marketingAuthorizationNumber</code>/46149</p><p><b>subject</b>: <a href="Bundle-d8afb81e-4e53-4c39-abea-562bfd84aeb4.html#MedicinalProductDefinition_Aprokam-50mg-Powder-SE-IS-MPD">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001677-00046149,http://ema.europa.eu/fhir/eurdId#615; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder for solution for injection; indication = Antibiotikaprofylax mot postoperativ endoftalmit efter kataraktoperation. Beakta de officiella riktlinjerna gÀllande korrekt anvÀndning av antibakteriella lÀkemedel, inkluderande riktlinjer för antibiotikaprofylax vid ögonkirurgi.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = S01AA27</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>: 2012-07-12</p><p><b>holder</b>: <a href="Bundle-d8afb81e-4e53-4c39-abea-562bfd84aeb4.html#Organization_LOC-100005605">Organization Laboratoires THEA</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>2012-07-12</td></tr></table></div>
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<code value="220000000061"/>
<display value="Marketing Authorisation"/>
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<code value="100000000535"/>
<display value="Kingdom of Sweden"/>
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<dateDateTime value="2012-07-12"/>
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<AdministrableProductDefinition>
<id value="Aprokam-50mg-Powder-SE-IS-APD"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T09:24:30.740+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition"/>
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<language value="en"/>
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<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_Aprokam-50mg-Powder-SE-IS-APD"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition Aprokam-50mg-Powder-SE-IS-APD</b></p><a name="Aprokam-50mg-Powder-SE-IS-APD"> </a><a name="hcAprokam-50mg-Powder-SE-IS-APD"> </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">version: 1; Last updated: 2025-11-26 09:24:30+0000</p><p style="margin-bottom: 0px">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition</code></p></div><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="Bundle-d8afb81e-4e53-4c39-abea-562bfd84aeb4.html#MedicinalProductDefinition_Aprokam-50mg-Powder-SE-IS-MPD">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001677-00046149,http://ema.europa.eu/fhir/eurdId#615; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder for solution for injection; indication = Antibiotikaprofylax mot postoperativ endoftalmit efter kataraktoperation. Beakta de officiella riktlinjerna gÀllande korrekt anvÀndning av antibakteriella lÀkemedel, inkluderande riktlinjer för antibiotikaprofylax vid ögonkirurgi.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = S01AA27</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073863}">Solution for injection</span></p><p><b>producedFrom</b>: <a href="Bundle-d8afb81e-4e53-4c39-abea-562bfd84aeb4.html#ManufacturedItemDefinition_Aprokam-50mg-Powder-SE-IS-MID">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial</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 100000125763}">Intracameral use</span></td></tr></table></div>
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<status value="active"/>
<formOf>
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</formOf>
<administrableDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073863"/>
<display value="Solution for injection"/>
</coding>
</administrableDoseForm>
<producedFrom>
<reference
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</producedFrom>
<routeOfAdministration>
<code>
<coding>
<system
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<code value="100000125763"/>
<display value="Intracameral use"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
<search>
<mode value="include"/>
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</entry>
<entry>
<fullUrl
value="http://sandbox.hl7europe.eu/unicom/fhir/PackagedProductDefinition/Aprokam-50mg-Powder-SE-IS-PPD02"/>
<resource>
<PackagedProductDefinition>
<id value="Aprokam-50mg-Powder-SE-IS-PPD02"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T09:27:10.988+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_Aprokam-50mg-Powder-SE-IS-PPD02"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition Aprokam-50mg-Powder-SE-IS-PPD02</b></p><a name="Aprokam-50mg-Powder-SE-IS-PPD02"> </a><a name="hcAprokam-50mg-Powder-SE-IS-PPD02"> </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">version: 1; Last updated: 2025-11-26 09:27:10+0000</p><p style="margin-bottom: 0px">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition</code></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/example/pcid</code>/?ngen-9?</p><p><b>packageFor</b>: <a href="Bundle-d8afb81e-4e53-4c39-abea-562bfd84aeb4.html#MedicinalProductDefinition_Aprokam-50mg-Powder-SE-IS-MPD">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001677-00046149,http://ema.europa.eu/fhir/eurdId#615; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder for solution for injection; indication = Antibiotikaprofylax mot postoperativ endoftalmit efter kataraktoperation. Beakta de officiella riktlinjerna gÀllande korrekt anvÀndning av antibakteriella lÀkemedel, inkluderande riktlinjer för antibiotikaprofylax vid ögonkirurgi.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = S01AA27</a></p><p><b>containedItemQuantity</b>: 10 Vial<span style="background: LightGoldenRodYellow"> (Details: 200000000014 code200000002158 = '200000002158')</span></p><p><b>description</b>: </p><div><p>Injektionsflaska, 10 x 50 mg (inkl 10 sterila kanyler)</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><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073563}">Vial</span></p><p><b>quantity</b>: 10</p><p><b>material</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003203}">Glass</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-d8afb81e-4e53-4c39-abea-562bfd84aeb4.html#ManufacturedItemDefinition_Aprokam-50mg-Powder-SE-IS-MID">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial</a></td></tr></table><p><b>amount</b>: 10 vial<span style="background: LightGoldenRodYellow"> (Details: 200000000014 code200000002158 = '200000002158')</span></p></blockquote></blockquote></blockquote></div>
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<identifier>
<system value="http://ema.europa.eu/example/pcid"/>
</identifier>
<packageFor>
<reference
value="MedicinalProductDefinition/Aprokam-50mg-Powder-SE-IS-MPD"/>
</packageFor>
<containedItemQuantity>
<value value="10"/>
<unit value="Vial"/>
<system value="http://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002158"/>
</containedItemQuantity>
<description
value="Injektionsflaska, 10 x 50 mg (inkl 10 sterila kanyler)"/>
<marketingStatus>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000535"/>
<display value="Kingdom of Sweden"/>
</coding>
</country>
<status>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000072052"/>
<code value="100000072083"/>
<display value="Marketed"/>
</coding>
</status>
</marketingStatus>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system
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<code value="200000003529"/>
<display value="Cardboard"/>
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<packaging>
<type>
<coding>
<system
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<code value="100000073563"/>
<display value="Vial"/>
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<quantity value="10"/>
<material>
<coding>
<system
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<code value="200000003203"/>
<display value="Glass"/>
</coding>
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<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/Aprokam-50mg-Powder-SE-IS-MID"/>
</reference>
</item>
<amount>
<value value="10"/>
<unit value="vial"/>
<system
value="http://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002158"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
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<search>
<mode value="include"/>
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</entry>
<entry>
<fullUrl
value="http://sandbox.hl7europe.eu/unicom/fhir/PackagedProductDefinition/Aprokam-50mg-Powder-SE-IS-PPD01"/>
<resource>
<PackagedProductDefinition>
<id value="Aprokam-50mg-Powder-SE-IS-PPD01"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T09:27:47.638+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_Aprokam-50mg-Powder-SE-IS-PPD01"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition Aprokam-50mg-Powder-SE-IS-PPD01</b></p><a name="Aprokam-50mg-Powder-SE-IS-PPD01"> </a><a name="hcAprokam-50mg-Powder-SE-IS-PPD01"> </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">version: 1; Last updated: 2025-11-26 09:27:47+0000</p><p style="margin-bottom: 0px">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition</code></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/example/pcid</code>/?ngen-9?</p><p><b>packageFor</b>: <a href="Bundle-d8afb81e-4e53-4c39-abea-562bfd84aeb4.html#MedicinalProductDefinition_Aprokam-50mg-Powder-SE-IS-MPD">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001677-00046149,http://ema.europa.eu/fhir/eurdId#615; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder for solution for injection; indication = Antibiotikaprofylax mot postoperativ endoftalmit efter kataraktoperation. Beakta de officiella riktlinjerna gÀllande korrekt anvÀndning av antibakteriella lÀkemedel, inkluderande riktlinjer för antibiotikaprofylax vid ögonkirurgi.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = S01AA27</a></p><p><b>containedItemQuantity</b>: 10 Vial<span style="background: LightGoldenRodYellow"> (Details: 200000000014 code200000002158 = '200000002158')</span></p><p><b>description</b>: </p><div><p>Injektionsflaska, 10 x 50 mg</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><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073563}">Vial</span></p><p><b>quantity</b>: 10</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><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073563}">Vial</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003203}">Glass</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-d8afb81e-4e53-4c39-abea-562bfd84aeb4.html#ManufacturedItemDefinition_Aprokam-50mg-Powder-SE-IS-MID">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial</a></td></tr></table><p><b>amount</b>: 1 Vial<span style="background: LightGoldenRodYellow"> (Details: 200000000014 code200000002158 = '200000002158')</span></p></blockquote></blockquote></blockquote></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/example/pcid"/>
</identifier>
<packageFor>
<reference
value="MedicinalProductDefinition/Aprokam-50mg-Powder-SE-IS-MPD"/>
</packageFor>
<containedItemQuantity>
<value value="10"/>
<unit value="Vial"/>
<system value="http://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002158"/>
</containedItemQuantity>
<description value="Injektionsflaska, 10 x 50 mg"/>
<marketingStatus>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000535"/>
<display value="Kingdom of Sweden"/>
</coding>
</country>
<status>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000072052"/>
<code value="100000072083"/>
<display value="Marketed"/>
</coding>
</status>
</marketingStatus>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003529"/>
<display value="Cardboard"/>
</coding>
</material>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073563"/>
<display value="Vial"/>
</coding>
</type>
<quantity value="10"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003529"/>
<display value="Cardboard"/>
</coding>
</material>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073563"/>
<display value="Vial"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003203"/>
<display value="Glass"/>
</coding>
</material>
<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/Aprokam-50mg-Powder-SE-IS-MID"/>
</reference>
</item>
<amount>
<value value="1"/>
<unit value="Vial"/>
<system
value="http://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002158"/>
</amount>
</containedItem>
</packaging>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
<search>
<mode value="include"/>
</search>
</entry>
<entry>
<fullUrl
value="http://sandbox.hl7europe.eu/unicom/fhir/Ingredient/Aprokam-50mg-Powder-SE-IS-ING"/>
<resource>
<Ingredient>
<id value="Aprokam-50mg-Powder-SE-IS-ING"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T09:26:31.100+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_Aprokam-50mg-Powder-SE-IS-ING"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Aprokam-50mg-Powder-SE-IS-ING</b></p><a name="Aprokam-50mg-Powder-SE-IS-ING"> </a><a name="hcAprokam-50mg-Powder-SE-IS-ING"> </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">version: 1; Last updated: 2025-11-26 09:26:31+0000</p><p style="margin-bottom: 0px">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient</code></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-d8afb81e-4e53-4c39-abea-562bfd84aeb4.html#MedicinalProductDefinition_Aprokam-50mg-Powder-SE-IS-MPD">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001677-00046149,http://ema.europa.eu/fhir/eurdId#615; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder for solution for injection; indication = Antibiotikaprofylax mot postoperativ endoftalmit efter kataraktoperation. Beakta de officiella riktlinjerna gÀllande korrekt anvÀndning av antibakteriella lÀkemedel, inkluderande riktlinjer för antibiotikaprofylax vid ögonkirurgi.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = S01AA27</a></li><li><a href="Bundle-d8afb81e-4e53-4c39-abea-562bfd84aeb4.html#ManufacturedItemDefinition_Aprokam-50mg-Powder-SE-IS-MID">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial</a></li><li><a href="Bundle-d8afb81e-4e53-4c39-abea-562bfd84aeb4.html#AdministrableProductDefinition_Aprokam-50mg-Powder-SE-IS-APD">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for injection</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 100000091436}">cefuroxime sodium</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 52.6 milligram(s)<span style="background: LightGoldenRodYellow"> (Details: 100000110633 code100000110655 = '100000110655')</span>/1 unit(s)<span style="background: LightGoldenRodYellow"> (Details: 100000110633 code100000110756 = '100000110756')</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 100000092667}">cefuroxime</span></td></tr></table><p><b>strength</b>: 50 milligram(s)<span style="background: LightGoldenRodYellow"> (Details: 100000110633 code100000110655 = '100000110655')</span>/1 unit(s)<span style="background: LightGoldenRodYellow"> (Details: 100000110633 code100000110756 = '100000110756')</span></p></blockquote></blockquote></blockquote></div>
</text>
<status value="active"/>
<for>
<reference
value="MedicinalProductDefinition/Aprokam-50mg-Powder-SE-IS-MPD"/>
</for>
<for>
<reference
value="ManufacturedItemDefinition/Aprokam-50mg-Powder-SE-IS-MID"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/Aprokam-50mg-Powder-SE-IS-APD"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072050"/>
<code value="100000072072"/>
<display value="Active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="https://spor.azure-api.net/sms/api/v2/SubstanceDefinition"/>
<code value="100000091436"/>
<display value="cefuroxime sodium"/>
</coding>
</concept>
</code>
<strength>
<concentrationRatio>
<numerator>
<value value="52.6"/>
<unit value="milligram(s)"/>
<system
value="http://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="unit(s)"/>
<system
value="http://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110756"/>
</denominator>
</concentrationRatio>
<referenceStrength>
<substance>
<concept>
<coding>
<system
value="https://spor.azure-api.net/sms/api/v2/SubstanceDefinition"/>
<code value="100000092667"/>
<display value="cefuroxime"/>
</coding>
</concept>
</substance>
<strengthRatio>
<numerator>
<value value="50"/>
<unit value="milligram(s)"/>
<system
value="http://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="unit(s)"/>
<system
value="http://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110756"/>
</denominator>
</strengthRatio>
</referenceStrength>
</strength>
</substance>
</Ingredient>
</resource>
<search>
<mode value="include"/>
</search>
</entry>
<entry>
<fullUrl
value="http://sandbox.hl7europe.eu/unicom/fhir/ManufacturedItemDefinition/Aprokam-50mg-Powder-SE-IS-MID"/>
<resource>
<ManufacturedItemDefinition>
<id value="Aprokam-50mg-Powder-SE-IS-MID"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T09:22:19.658+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_Aprokam-50mg-Powder-SE-IS-MID"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition Aprokam-50mg-Powder-SE-IS-MID</b></p><a name="Aprokam-50mg-Powder-SE-IS-MID"> </a><a name="hcAprokam-50mg-Powder-SE-IS-MID"> </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">version: 1; Last updated: 2025-11-26 09:22:19+0000</p><p style="margin-bottom: 0px">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition</code></p></div><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073866}">Powder for solution for injection</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000014 200000002158}">Vial</span></p></div>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073866"/>
<display value="Powder for solution for injection"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002158"/>
<display value="Vial"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
<search>
<mode value="include"/>
</search>
</entry>
<entry>
<fullUrl
value="http://sandbox.hl7europe.eu/unicom/fhir/Organization/LOC-100005605"/>
<resource>
<Organization>
<id value="LOC-100005605"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T09:20:15.753+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_LOC-100005605"> </a><p class="res-header-id"><b>Generated Narrative: Organization LOC-100005605</b></p><a name="LOC-100005605"> </a><a name="hcLOC-100005605"> </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">version: 1; Last updated: 2025-11-26 09:20:15+0000</p><p style="margin-bottom: 0px">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization</code></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/v1/locations</code>/LOC-100005605</p><p><b>name</b>: Laboratoires THEA</p></div>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<value value="LOC-100005605"/>
</identifier>
<name value="Laboratoires THEA"/>
</Organization>
</resource>
<search>
<mode value="include"/>
</search>
</entry>
</Bundle>
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group.
Package hl7.fhir.uv.emedicinal-product-info#1.1.0 based on FHIR 5.0.0.
Generated
2026-01-02
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