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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<resource>
<MedicinalProductDefinition>
<id value="Glucophage-850mg-Tablet-SE-BS-MPD"/>
<meta>
<profile
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_Glucophage-850mg-Tablet-SE-BS-MPD"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition Glucophage-850mg-Tablet-SE-BS-MPD</b></p><a name="Glucophage-850mg-Tablet-SE-BS-MPD"> </a><a name="hcGlucophage-850mg-Tablet-SE-BS-MPD"> </a><a name="hcGlucophage-850mg-Tablet-SE-BS-MPD-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/mpId</code>/SE-100000174-00010799, <code>http://ema.europa.eu/fhir/eurdId</code>/2001</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>Behandling av diabetes mellitus typ 2, speciellt hos överviktiga patienter, där enbart diet och motion inte ger tillräcklig metabolisk kontroll. • Hos vuxna kan Glucophage användas som monoterapi eller i kombination med andra perorala diabetesmedel eller med insulin. • Hos barn från 10 år och ungdomar kan Glucophage användas som monoterapi eller i kombination med insulin. En reduktion av diabetiska komplikationer har visats hos överviktiga vuxna patienter med typ 2 diabetes som behandlades med metformin som förstahandspreparat efter att ha sviktat på dietbehandling (se avsnitt 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 100000094031}">metformin</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Glucophage 850 mg filmdragerad tablett</p><blockquote><p><b>part</b></p><p><b>part</b>: Glucophage</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>: 850 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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<value value="2001"/>
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<system value="https://spor.ema.europa.eu/v1/lists/100000000004"/>
<code value="100000000012"/>
<display value="Human use"/>
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<system value="https://spor.ema.europa.eu/v1/lists/200000005003"/>
<code value="200000005004"/>
<display value="Current"/>
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<combinedPharmaceuticalDoseForm>
<coding>
<system
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<code value="100000073665"/>
<display value="Film-coated tablet"/>
</coding>
</combinedPharmaceuticalDoseForm>
<indication
value="Behandling av diabetes mellitus typ 2, speciellt hos överviktiga patienter, där enbart diet och motion inte ger tillräcklig metabolisk kontroll. • Hos vuxna kan Glucophage användas som monoterapi eller i kombination med andra perorala diabetesmedel eller med insulin. • Hos barn från 10 år och ungdomar kan Glucophage användas som monoterapi eller i kombination med insulin. En reduktion av diabetiska komplikationer har visats hos överviktiga vuxna patienter med typ 2 diabetes som behandlades med metformin som förstahandspreparat efter att ha sviktat på dietbehandling (se avsnitt 5.1)."/>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072051"/>
<code value="100000072084"/>
<display
value="Medicinal product subject to medical prescription"/>
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</legalStatusOfSupply>
<classification>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000093533"/>
<code value="100000094031"/>
<display value="metformin"/>
</coding>
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<name>
<productName value="Glucophage 850 mg filmdragerad tablett"/>
<part>
<part value="Glucophage"/>
<type>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000002"/>
<display value="Invented name part"/>
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</type>
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<part>
<part value="850 mg"/>
<type>
<coding>
<system
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<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
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<part>
<part value="Filmdragerad tablett"/>
<type>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000005"/>
<display value="Pharmaceutical dose form part"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000535"/>
<display value="Kingdom of Sweden"/>
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<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="sv"/>
<display value="Swedish"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
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<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/RegulatedAuthorization/Glucophage-850mg-Tablet-SE-BS-RA"/>
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<RegulatedAuthorization>
<id value="Glucophage-850mg-Tablet-SE-BS-RA"/>
<meta>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_Glucophage-850mg-Tablet-SE-BS-RA"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization Glucophage-850mg-Tablet-SE-BS-RA</b></p><a name="Glucophage-850mg-Tablet-SE-BS-RA"> </a><a name="hcGlucophage-850mg-Tablet-SE-BS-RA"> </a><a name="hcGlucophage-850mg-Tablet-SE-BS-RA-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/marketingAuthorizationNumber</code>/10799</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Glucophage-850mg-Tablet-SE-BS-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100000174-00010799,http://ema.europa.eu/fhir/eurdId#2001; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; indication = Behandling av diabetes mellitus typ 2, speciellt hos överviktiga patienter, där enbart diet och motion inte ger tillräcklig metabolisk kontroll. • Hos vuxna kan Glucophage användas som monoterapi eller i kombination med andra perorala diabetesmedel eller med insulin. • Hos barn från 10 år och ungdomar kan Glucophage användas som monoterapi eller i kombination med insulin. En reduktion av diabetiska komplikationer har visats hos överviktiga vuxna patienter med typ 2 diabetes som behandlades med metformin som förstahandspreparat efter att ha sviktat på dietbehandling (se avsnitt 5.1).; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = metformin</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>: 1988-06-17</p><p><b>holder</b>: <a href="Organization-LOC-100005581.html">Organization Merck Sante</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>1988-06-17</td></tr></table></div>
</text>
<identifier>
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value="http://ema.europa.eu/fhir/marketingAuthorizationNumber"/>
<value value="10799"/>
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<subject>🔗
<reference
value="MedicinalProductDefinition/Glucophage-850mg-Tablet-SE-BS-MPD"/>
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<type>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/220000000060"/>
<code value="220000000061"/>
<display value="Marketing Authorisation"/>
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</type>
<region>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000535"/>
<display value="Kingdom of Sweden"/>
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</region>
<status>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072049"/>
<code value="100000072099"/>
<display value="Valid"/>
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<statusDate value="1988-06-17"/>
<holder>🔗
<reference value="Organization/LOC-100005581"/>
</holder>
<case>
<type>
<coding>
<system
value="https://ema.europa.eu/fhir/authorisationDateType"/>
<code value="dateOfFirstAuthorisation"/>
<display value="First Authorisation"/>
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<dateDateTime value="1988-06-17"/>
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</entry>
<entry>
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value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/PackagedProductDefinition/Glucophage-850mg-Tablet-SE-BS-PPD"/>
<resource>
<PackagedProductDefinition>
<id value="Glucophage-850mg-Tablet-SE-BS-PPD"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition"/>
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_Glucophage-850mg-Tablet-SE-BS-PPD"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition Glucophage-850mg-Tablet-SE-BS-PPD</b></p><a name="Glucophage-850mg-Tablet-SE-BS-PPD"> </a><a name="hcGlucophage-850mg-Tablet-SE-BS-PPD"> </a><a name="hcGlucophage-850mg-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-Glucophage-850mg-Tablet-SE-BS-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100000174-00010799,http://ema.europa.eu/fhir/eurdId#2001; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; indication = Behandling av diabetes mellitus typ 2, speciellt hos överviktiga patienter, där enbart diet och motion inte ger tillräcklig metabolisk kontroll. • Hos vuxna kan Glucophage användas som monoterapi eller i kombination med andra perorala diabetesmedel eller med insulin. • Hos barn från 10 år och ungdomar kan Glucophage användas som monoterapi eller i kombination med insulin. En reduktion av diabetiska komplikationer har visats hos överviktiga vuxna patienter med typ 2 diabetes som behandlades med metformin som förstahandspreparat efter att ha sviktat på dietbehandling (se avsnitt 5.1).; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = metformin</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 tabletter</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>
<identifier>
<system value="http://ema.europa.eu/example/pcid"/>
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<packageFor>🔗
<reference
value="MedicinalProductDefinition/Glucophage-850mg-Tablet-SE-BS-MPD"/>
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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 tabletter"/>
<marketingStatus>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000535"/>
<display value="Kingdom of Sweden"/>
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<status>
<coding>
<system
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<code value="100000072083"/>
<display value="Marketed"/>
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<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073498"/>
<display value="Box"/>
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<quantity value="1"/>
<material>
<coding>
<system
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<code value="200000003529"/>
<display value="Cardboard"/>
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</material>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073496"/>
<display value="Blister"/>
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</type>
<quantity value="4"/>
<material>
<coding>
<system
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<code value="200000003200"/>
<display value="Aluminium"/>
</coding>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003222"/>
<display value="PolyVinyl Chloride"/>
</coding>
</material>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/Glucophage-850mg-Tablet-SE-BS-MID"/>
</reference>
</item>
<amount>
<value value="25"/>
<unit value="Tablet"/>
<system
value="http://spor.ema.europa.eu/v1/lists/100000110633~200000000014"/>
<code value="200000002152"/>
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<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/ManufacturedItemDefinition/Glucophage-850mg-Tablet-SE-BS-MID"/>
<resource>
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<id value="Glucophage-850mg-Tablet-SE-BS-MID"/>
<meta>
<profile
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</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_Glucophage-850mg-Tablet-SE-BS-MID"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition Glucophage-850mg-Tablet-SE-BS-MID</b></p><a name="Glucophage-850mg-Tablet-SE-BS-MID"> </a><a name="hcGlucophage-850mg-Tablet-SE-BS-MID"> </a><a name="hcGlucophage-850mg-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"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073665"/>
<display value="Film-coated tablet"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
<display value="Tablet"/>
</coding>
</unitOfPresentation>
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</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Ingredient/Glucophage-850mg-Tablet-SE-BS-ING"/>
<resource>
<Ingredient>
<id value="Glucophage-850mg-Tablet-SE-BS-ING"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_Glucophage-850mg-Tablet-SE-BS-ING"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Glucophage-850mg-Tablet-SE-BS-ING</b></p><a name="Glucophage-850mg-Tablet-SE-BS-ING"> </a><a name="hcGlucophage-850mg-Tablet-SE-BS-ING"> </a><a name="hcGlucophage-850mg-Tablet-SE-BS-ING-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="MedicinalProductDefinition-Glucophage-850mg-Tablet-SE-BS-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100000174-00010799,http://ema.europa.eu/fhir/eurdId#2001; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; indication = Behandling av diabetes mellitus typ 2, speciellt hos överviktiga patienter, där enbart diet och motion inte ger tillräcklig metabolisk kontroll. • Hos vuxna kan Glucophage användas som monoterapi eller i kombination med andra perorala diabetesmedel eller med insulin. • Hos barn från 10 år och ungdomar kan Glucophage användas som monoterapi eller i kombination med insulin. En reduktion av diabetiska komplikationer har visats hos överviktiga vuxna patienter med typ 2 diabetes som behandlades med metformin som förstahandspreparat efter att ha sviktat på dietbehandling (se avsnitt 5.1).; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = metformin</a></li><li><a href="ManufacturedItemDefinition-Glucophage-850mg-Tablet-SE-BS-MID.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href="AdministrableProductDefinition-Glucophage-850mg-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 100000091366}">Metformin hydrochloride</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>presentation</b>: 850 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 100000085448}">Metformin</span></td></tr></table><p><b>strength</b>: 663 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>
</text>
<status value="active"/>
<for>🔗
<reference
value="MedicinalProductDefinition/Glucophage-850mg-Tablet-SE-BS-MPD"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/Glucophage-850mg-Tablet-SE-BS-MID"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/Glucophage-850mg-Tablet-SE-BS-APD"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072050"/>
<code value="100000072072"/>
<display value="Active"/>
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<substance>
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<concept>
<coding>
<system
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<code value="100000091366"/>
<display value="Metformin hydrochloride"/>
</coding>
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</code>
<strength>
<presentationRatio>
<numerator>
<value value="850"/>
<unit value="milligram(s)"/>
<system
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<code value="100000110655"/>
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<value value="1"/>
<unit value="tablet"/>
<system
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