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_MetforminSandoz-1000mg-Tablet-SE-BS-MPD"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition MetforminSandoz-1000mg-Tablet-SE-BS-MPD</b></p><a name="MetforminSandoz-1000mg-Tablet-SE-BS-MPD"> </a><a name="hcMetforminSandoz-1000mg-Tablet-SE-BS-MPD"> </a><a name="hcMetforminSandoz-1000mg-Tablet-SE-BS-MPD-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/mpId</code>/SE-100000848-00053521, <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, där enbart diet och motion inte ger tillräcklig glykemisk kontroll. - Hos vuxna kan Metformin Sandoz 500 mg/850 mg användas som monoterapi, i kombination med andra perorala diabetesmedel eller med insulin. - Hos barn från 10 år och ungdomar kan Metformin Sandoz 500 mg/850 mg användas som monoterapi eller i kombination med insulin. En minskning 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>: Metformin Sandoz 1000 mg filmdragerad tablett</p><blockquote><p><b>part</b></p><p><b>part</b>: Metformin Sandoz</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>: 1000 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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<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_MetforminSandoz-1000mg-Tablet-SE-BS-RA"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization MetforminSandoz-1000mg-Tablet-SE-BS-RA</b></p><a name="MetforminSandoz-1000mg-Tablet-SE-BS-RA"> </a><a name="hcMetforminSandoz-1000mg-Tablet-SE-BS-RA"> </a><a name="hcMetforminSandoz-1000mg-Tablet-SE-BS-RA-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/marketingAuthorizationNumber</code>/53521</p><p><b>subject</b>: <a href="MedicinalProductDefinition-MetforminSandoz-1000mg-Tablet-SE-BS-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100000848-00053521,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, där enbart diet och motion inte ger tillräcklig glykemisk kontroll. - Hos vuxna kan Metformin Sandoz 500 mg/850 mg användas som monoterapi, i kombination med andra perorala diabetesmedel eller med insulin. - Hos barn från 10 år och ungdomar kan Metformin Sandoz 500 mg/850 mg användas som monoterapi eller i kombination med insulin. En minskning 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>: 2017-09-29</p><p><b>holder</b>: <a href="Organization-LOC-100001468.html">Organization Sandoz A/S</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>2017-09-29</td></tr></table></div>
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<holder>🔗
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_MetforminSandoz-1000mg-Tablet-SE-BS-PPD"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition MetforminSandoz-1000mg-Tablet-SE-BS-PPD</b></p><a name="MetforminSandoz-1000mg-Tablet-SE-BS-PPD"> </a><a name="hcMetforminSandoz-1000mg-Tablet-SE-BS-PPD"> </a><a name="hcMetforminSandoz-1000mg-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-MetforminSandoz-1000mg-Tablet-SE-BS-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100000848-00053521,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, där enbart diet och motion inte ger tillräcklig glykemisk kontroll. - Hos vuxna kan Metformin Sandoz 500 mg/850 mg användas som monoterapi, i kombination med andra perorala diabetesmedel eller med insulin. - Hos barn från 10 år och ungdomar kan Metformin Sandoz 500 mg/850 mg användas som monoterapi eller i kombination med insulin. En minskning 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>: 180 Tablet<span style="background: LightGoldenRodYellow"> (Details: 200000000014 code200000002152 = '200000002152')</span></p><p><b>description</b>: </p><div><p>Blister, 180 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>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_MetforminSandoz-1000mg-Tablet-SE-BS-PPD-02"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition MetforminSandoz-1000mg-Tablet-SE-BS-PPD-02</b></p><a name="MetforminSandoz-1000mg-Tablet-SE-BS-PPD-02"> </a><a name="hcMetforminSandoz-1000mg-Tablet-SE-BS-PPD-02"> </a><a name="hcMetforminSandoz-1000mg-Tablet-SE-BS-PPD-02-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-MetforminSandoz-1000mg-Tablet-SE-BS-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100000848-00053521,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, där enbart diet och motion inte ger tillräcklig glykemisk kontroll. - Hos vuxna kan Metformin Sandoz 500 mg/850 mg användas som monoterapi, i kombination med andra perorala diabetesmedel eller med insulin. - Hos barn från 10 år och ungdomar kan Metformin Sandoz 500 mg/850 mg användas som monoterapi eller i kombination med insulin. En minskning 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>: 60 Tablet<span style="background: LightGoldenRodYellow"> (Details: 200000000014 code200000002152 = '200000002152')</span></p><p><b>description</b>: </p><div><p>Blister, 60 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>
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<id value="MetforminSandoz-1000mg-Tablet-SE-BS-MID"/>
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<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_MetforminSandoz-1000mg-Tablet-SE-BS-MID"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition MetforminSandoz-1000mg-Tablet-SE-BS-MID</b></p><a name="MetforminSandoz-1000mg-Tablet-SE-BS-MID"> </a><a name="hcMetforminSandoz-1000mg-Tablet-SE-BS-MID"> </a><a name="hcMetforminSandoz-1000mg-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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<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073665"/>
<display value="Film-coated tablet"/>
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<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
<display value="Tablet"/>
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<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Ingredient/MetforminSandoz-1000mg-Tablet-SE-BS-ING"/>
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<Ingredient>
<id value="MetforminSandoz-1000mg-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_MetforminSandoz-1000mg-Tablet-SE-BS-ING"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient MetforminSandoz-1000mg-Tablet-SE-BS-ING</b></p><a name="MetforminSandoz-1000mg-Tablet-SE-BS-ING"> </a><a name="hcMetforminSandoz-1000mg-Tablet-SE-BS-ING"> </a><a name="hcMetforminSandoz-1000mg-Tablet-SE-BS-ING-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="MedicinalProductDefinition-MetforminSandoz-1000mg-Tablet-SE-BS-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100000848-00053521,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, där enbart diet och motion inte ger tillräcklig glykemisk kontroll. - Hos vuxna kan Metformin Sandoz 500 mg/850 mg användas som monoterapi, i kombination med andra perorala diabetesmedel eller med insulin. - Hos barn från 10 år och ungdomar kan Metformin Sandoz 500 mg/850 mg användas som monoterapi eller i kombination med insulin. En minskning 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-MetforminSandoz-1000mg-Tablet-SE-BS-MID.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href="AdministrableProductDefinition-MetforminSandoz-1000mg-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>: 1000 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>: 780 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/MetforminSandoz-1000mg-Tablet-SE-BS-MPD"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/MetforminSandoz-1000mg-Tablet-SE-BS-MID"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/MetforminSandoz-1000mg-Tablet-SE-BS-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="100000091366"/>
<display value="Metformin hydrochloride"/>
</coding>
</concept>
</code>
<strength>
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<numerator>
<value value="1000"/>
<unit value="milligram(s)"/>
<system
value="http://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"/>
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<substance>
<concept>
<coding>
<system
value="https://spor.azure-api.net/sms/api/v2/SubstanceDefinition"/>
<code value="100000085448"/>
<display value="Metformin"/>
</coding>
</concept>
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<strengthRatio>
<numerator>
<value value="780"/>
<unit value="milligram(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
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<denominator>
<value value="1"/>
<unit value="tablet"/>
<system
value="http://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
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</Ingredient>
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</entry>
<entry>
<fullUrl
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<resource>
<AdministrableProductDefinition>
<id value="MetforminSandoz-1000mg-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_MetforminSandoz-1000mg-Tablet-SE-BS-APD"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition MetforminSandoz-1000mg-Tablet-SE-BS-APD</b></p><a name="MetforminSandoz-1000mg-Tablet-SE-BS-APD"> </a><a name="hcMetforminSandoz-1000mg-Tablet-SE-BS-APD"> </a><a name="hcMetforminSandoz-1000mg-Tablet-SE-BS-APD-en-US"> </a><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="MedicinalProductDefinition-MetforminSandoz-1000mg-Tablet-SE-BS-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100000848-00053521,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, där enbart diet och motion inte ger tillräcklig glykemisk kontroll. - Hos vuxna kan Metformin Sandoz 500 mg/850 mg användas som monoterapi, i kombination med andra perorala diabetesmedel eller med insulin. - Hos barn från 10 år och ungdomar kan Metformin Sandoz 500 mg/850 mg användas som monoterapi eller i kombination med insulin. En minskning 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>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-MetforminSandoz-1000mg-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>🔗
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value="MedicinalProductDefinition/MetforminSandoz-1000mg-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>🔗
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<coding>
<system
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<code value="100000073619"/>
<display value="Oral use"/>
</coding>
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</AdministrableProductDefinition>
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</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Organization/LOC-100001468"/>
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<Organization>
<id value="LOC-100001468"/>
<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-100001468"> </a><p class="res-header-id"><b>Generated Narrative: Organization LOC-100001468</b></p><a name="LOC-100001468"> </a><a name="hcLOC-100001468"> </a><a name="hcLOC-100001468-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/v1/locations</code>/LOC-100001468</p><p><b>name</b>: Sandoz A/S</p></div>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<value value="LOC-100001468"/>
</identifier>
<name value="Sandoz A/S"/>
</Organization>
</resource>
</entry>
</Bundle>