ePI document Bundle for Dovato 50 mg/300 mg film-coated tablets Package Leaflet for language es - TTL Representation - Gravitate Health FHIR Implementation Guide v0.1.0

Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/gravitate-health/ and changes regularly. See the Directory of published versions
: ePI document Bundle for Dovato 50 mg/300 mg film-coated tablets Package Leaflet for language es - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

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fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"es\" lang=\"es\"><a name=\"Composition_composition-es-16598f252d07b4784b82ba43cf9e847e\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-es-16598f252d07b4784b82ba43cf9e847e</b></p><a name=\"composition-es-16598f252d07b4784b82ba43cf9e847e\"> </a><a name=\"hccomposition-es-16598f252d07b4784b82ba43cf9e847e\"> </a><a name=\"composition-es-16598f252d07b4784b82ba43cf9e847e-en-US\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Language: es</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>nan</code>/c90d140de2d4ddf3b2a2617fc2fc996c</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi/ 100000155538}\">Package Leaflet</span></p><p><b>category</b>: <span title=\"Codes:{http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs R}\">Raw</span></p><p><b>date</b>: 2022-04-29 13:28:17+0000</p><p><b>author</b>: <a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#Organization_mah-31ff1af739c7dcf77386a86f8dd83d29\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>title</b>: TEST PURPOSES ONLY - Dovato 50 mg/300 mg film-coated tablets</p><h3>Attesters</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/composition-attestation-mode official}\">Official</span></td><td>2022-04-29 13:28:17+0000</td></tr></table></div>"
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fhir:title [ fhir:v "B. PROSPECTO" ] ;
fhir:code [
      ( fhir:coding [
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fhir:text [
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fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"     ] ;
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    ( fhir:section [
fhir:title [ fhir:v "PROSPECTO: INFORMACIÓN PARA EL USUARIO" ] ;
fhir:code [
        ( fhir:coding [
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fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Prospecto: información para el paciente Dovato 50 mg/300 mg comprimidos recubiertos con película dolutegravir/lamivudina <b>Lea todo el prospecto detenidamente antes de empezar a tomar este medicamento, porque contiene información importante para usted.</b><ul><li>Conserve este prospecto, ya que puede tener que volver a leerlo.</li><li>Si tiene alguna duda, consulte a su médico o farmacéutico.</li><li>Este medicamento se le ha recetado solamente a usted, y no debe dárselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles.</li><li>Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.</li></ul></div>"       ]     ] [
fhir:title [ fhir:v "Contenido del prospecto" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ;
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fhir:text [ fhir:v "Contenido del prospecto" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Contenido del prospecto<ol><li>Qué es Dovato y para qué se utiliza</li><li>Qué necesita saber antes de empezar a tomar Dovato</li><li>Cómo tomar Dovato</li><li>Posibles efectos adversos</li><li>Conservación de Dovato</li><li>Contenido del envase e información adicional</li></ol></div>"       ]     ] [
fhir:title [ fhir:v "1. Qué es Dovato y para qué se utiliza" ] ;
fhir:code [
        ( fhir:coding [
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fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>1. Qué es Dovato y para qué se utiliza</b> Dovato es un medicamento que contiene dos principios activos usados para tratar la infección por el virus de la inmunodeficiencia humana (VIH): dolutegravir y lamivudina. Dolutegravir pertenece al grupo de medicamentos antirretrovirales llamados inhibidores de la integrasa (INI) y lamivudina pertenece a un grupo de medicamentos antirretrovirales denominados inhibidores de la transcriptasa inversa análogos de nucleósido (ITIAN).</div>"       ]     ] [
fhir:title [ fhir:v "2. Qué necesita saber antes de empezar a tomar Dovato" ] ;
fhir:code [
        ( fhir:coding [
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fhir:text [
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fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><strong>No tome Dovato</strong></p><ul><li>si es alérgico (hipersensible) a dolutegravir o lamivudina o a alguno de los demás componentes de este medicamento (incluidos en la sección 6)</li><li>si está tomando un medicamento llamado fampridina (también conocido como dalfampridina; utilizado para tratar la esclerosis múltiple).</li></ul><p>? Si cree que algo de esto le aplica, consulte a su médico.</p><p><strong>Advertencias y precauciones</strong> Algunas personas que toman Dovato u otros tratamientos combinados frente al VIH tienen un mayor riesgo de desarrollar efectos adversos graves que otras. Usted necesita saber que hay un mayor riesgo:</p><ul><li>si tiene una enfermedad hepática moderada o grave</li><li>si alguna vez ha tenido una enfermedad hepática, incluyendo hepatitis B o C (si tiene hepatitis B no deje de tomar Dovato sin el consejo de su médico, ya que podría empeorar)</li><li>si tiene un problema de riñón.</li></ul><p>? Consulte a su médico antes de empezar a tomar Dovato si le aplica alguna de estas condiciones. Puede necesitar pruebas adicionales, incluyendo análisis de sangre, mientras toma este medicamento. Para más información, ver sección 4.</p><p><em>Reacciones alérgicas</em></p><p>Dovato contiene dolutegravir. Dolutegravir puede producir una reacción alérgica grave conocida como reacción de hipersensibilidad. Usted necesita saber a qué signos y síntomas importantes debe estar atento mientras esté tomando Dovato.</p><p>? Lea la información “Reacciones alérgicas” en la sección 4 de este prospecto.</p><p><em>Esté atento a los síntomas importantes</em></p><p>Algunas personas que toman medicamentos para la infección por el VIH desarrollan otros trastornos, que pueden ser graves. Estos incluyen:</p><ul><li>síntomas de infecciones e inflamación</li><li>dolor en las articulaciones, rigidez y problemas de huesos.</li></ul><p>Usted necesita saber a qué signos y síntomas importantes debe estar atento mientras esté tomando Dovato.</p><p>? Lea la información sobre “Otros posibles efectos adversos” en la sección 4 de este prospecto.</p><p><strong>Niños</strong></p><p>Este medicamento no está indicado en niños menores de 12 años, porque no ha sido estudiado en estos pacientes.</p><p><strong>Otros medicamentos y Dovato</strong> Informe a su médico si está tomando, ha tomado recientemente o pudiera tener que tomar cualquier otro medicamento.</p><p>No tome Dovato con el siguiente medicamento:</p><ul><li>fampridina (también conocido como dalfampridina), utilizado para tratar la esclerosis múltiple.</li></ul><p>Algunos medicamentos pueden afectar al funcionamiento de Dovato o aumentar la probabilidad de sufrir efectos adversos. Dovato también puede afectar al funcionamiento de algunos otros medicamentos.</p><p>Informe a su médico si está tomando alguno de los siguientes medicamentos:</p><ul><li>metformina, para tratar la diabetes</li><li>medicamentos llamados antiácidos, para tratar la indigestión y el ardor de estómago. No tome un antiácido durante las 6 horas antes de tomar Dovato, o por lo menos 2 horas después de tomarlo (ver también sección 3, “Cómo tomar Dovato”).</li><li>suplementos o multivitamínicos que contienen calcio, hierro o magnesio. Si toma Dovato con comida, puede tomar los suplementos o multivitamínicos que contengan calcio, hierro o magnesio a la vez que Dovato. Si no toma Dovato con comida, no puede tomar un suplemento o multivitamínico que contenga calcio, hierro o magnesio durante las 6 horas antes de tomar Dovato, o por lo menos 2 horas después de tomarlo (ver también sección 3, “Cómo tomar Dovato”).</li><li>emtricitabina, etravirina, efavirenz, nevirapina o tipranavir/ritonavir, para tratar la infección por el VIH medicamentos (generalmente líquidos) que contengan sorbitol y otros polialcoholes (como xilitol, manitol, lactitol o maltitol), si se toman con regularidad</li><li>cladribina, utilizada para tratar la leucemia o la esclerosis múltiple</li><li>rifampicina, para tratar la tuberculosis (TB) y otras infecciones bacterianas</li><li>fenitoína y fenobarbital, para tratar la epilepsia</li><li>oxcarbazepina y carbamazepina, para tratar la epilepsia o el trastorno bipolar</li><li>hierba de San Juan (Hypericum perforatum), un medicamento a base de plantas para tratar la depresión.</li></ul><p>? Informe a su médico o farmacéutico si está tomando alguno de estos medicamentos. Su médico puede decidir ajustar su dosis o que usted necesite chequeos adicionales.</p><p><strong>Embarazo</strong></p><p>Si está embarazada, cree que podría estar embarazada o tiene intención de quedarse embarazada:</p><p>? Consulte a su médico sobre los riegos y beneficios de tomar Dovato.</p><p>Tomar Dovato en el momento de quedarse embarazada o durante las primeras seis semanas de embarazo puede aumentar el riesgo de un defecto de nacimiento, denominado defecto del tubo neural, como la espina bífida (malformación de la médula espinal).</p><p>Si existe la posibilidad de quedarse embarazada mientras está tomando Dovato:</p><p>? Consulte a su médico y valore si existe la necesidad de utilizar un método anticonceptivo, como preservativos o anticonceptivos orales.</p><p>Informe a su médico de inmediato si se queda embarazada o tiene intención de quedarse embarazada. Su médico revisará su tratamiento. No interrumpa el tratamiento con Dovato sin consultar a su médico, ya que esto podría dañarles a usted y a su hijo.</p><p><strong>Lactancia</strong></p><p><strong>No se recomienda</strong> que las mujeres que conviven con el VIH den el pecho porque la infección por VIH puede transmitirse al bebé a través de la leche materna.</p><p>Una pequeña cantidad de los componentes de Dovato también pueden pasar a la leche materna.</p><p>Si está dando el pecho o piensa en dar el pecho, debe consultar con su médico lo antes posible.</p><p><strong>Conducción y uso de máquinas</strong> Dovato puede hacer que se sienta mareado y puede tener otros efectos adversos que reduzcan su atención.</p>? No conduzca ni maneje maquinaria, a menos que esté seguro que no está afectado.</div>"       ]     ] [
fhir:title [ fhir:v "3. Cómo tomar Dovato" ] ;
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fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>3. Cómo tomar Dovato</b><p>Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico. En caso de duda, consulte de nuevo a su médico o farmacéutico.</p><ul><li>La dosis recomendada de Dovato es <b>un comprimido una vez al día.</b></li></ul><p>Trague el comprimido con un poco de líquido. Dovato se puede tomar con o sin alimentos.</p></div>"       ]     ] [
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fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>4. Posibles efectos adversos</b></p><p>Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran, <b>por lo que es muy importante que le comente a su médico cualquier cambio en su estado de salud.</b></p></div>"       ]     ] [
fhir:title [ fhir:v "5. Conservación de Dovato" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000155538" ]         ] ) ;
fhir:text [ fhir:v "5. Conservación de Dovato" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>5. Conservación de Dovato</b><p>Mantener este medicamento fuera de la vista y del alcance de los niños</p><p>No utilice este medicamento después de la fecha de caducidad que aparece en la caja y el frasco después de CAD. La fecha de caducidad es el último día del mes que se indica.</p><p>Este medicamento no requiere ninguna condición especial de conservación.</p><p>Los medicamentos no se deben tirar por los desagües ni a la basura. Pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que ya no necesita. De esta forma, ayudará a proteger el medio ambiente.</p></div>"       ]     ] [
fhir:title [ fhir:v "6. Contenido del envase e información adicional" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000155538" ]         ] ) ;
fhir:text [ fhir:v "6. Contenido del envase e información adicional" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>6. Contenido del envase e información adicional</b> <b>Composición de Dovato</b><ul><li>Los principios activos son dolutegravir y lamivudina. Cada comprimido contiene dolutegravir sódico equivalente a 50 mg de dolutegravir y 300 mg de lamivudina.</li><li>Los demás componentes son celulosa microcristalina, carboximetilalmidón sódico, estearato de magnesio, manitol (E421), povidona (K29/32), fumarato estearilo de sodio, hipromelosa (E464), macrogol, dióxido de titanio (E171).</li><li>Este medicamento contiene menos de 1 mmol de sodio (23 mg) por comprimido; esto es, esencialmente “exento de sodio”.</li></ul></div>"       ]     ] )
  ] ) . # 

<http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-dolutegravirsodium> a fhir:Ingredient ;
  fhir:id [ fhir:v "ingredient-for-dovato-dolutegravirsodium"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-dovato-dolutegravirsodium\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-for-dovato-dolutegravirsodium</b></p><a name=\"ingredient-for-dovato-dolutegravirsodium\"> </a><a name=\"hcingredient-for-dovato-dolutegravirsodium\"> </a><a name=\"ingredient-for-dovato-dolutegravirsodium-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/1Q1V9V5WYQ (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#ManufacturedItemDefinition_mid-49178f16170ee8a6bc2a4361c1748d5f\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#MedicinalProductDefinition_mp16598f252d07b4784b82ba43cf9e847e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#AdministrableProductDefinition_ap-49178f16170ee8a6bc2a4361c1748d5f\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072072}\">Active</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 1Q1V9V5WYQ}\">DOLUTEGRAVIR SODIUM</span></td></tr></table><h3>Strengths</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style=\"display: none\">*</td><td>50 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM  codemg = 'mg')</span></td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}\">active ingredient - basis of strength</span></td></tr></table></blockquote></div>"
  ] ; # 
  fhir:identifier [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1Q1V9V5WYQ" ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:for ( [
fhir:reference [ fhir:v "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f" ]
  ] [
fhir:reference [ fhir:v "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e" ]
  ] [
fhir:reference [ fhir:v "AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f" ]
  ] ) ; # 
  fhir:role [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000072072" ] ;
fhir:display [ fhir:v "Active" ]     ] )
  ] ; # 
  fhir:substance [
fhir:code [
fhir:concept [
        ( fhir:coding [
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ;
fhir:code [ fhir:v "1Q1V9V5WYQ" ] ;
fhir:display [ fhir:v "DOLUTEGRAVIR SODIUM" ]         ] )       ]     ] ;
    ( fhir:strength [
fhir:presentation [
a fhir:Quantity ;
fhir:value [ fhir:v "50"^^xsd:decimal ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "mg" ]       ] ;
fhir:basis [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v3-RoleClass"^^xsd:anyURI ] ;
fhir:code [ fhir:v "ACTIB" ] ;
fhir:display [ fhir:v "active ingredient - basis of strength" ]         ] )       ]     ] )
  ] . # 

<http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-lamivudine> a fhir:Ingredient ;
  fhir:id [ fhir:v "ingredient-for-dovato-lamivudine"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-dovato-lamivudine\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-for-dovato-lamivudine</b></p><a name=\"ingredient-for-dovato-lamivudine\"> </a><a name=\"hcingredient-for-dovato-lamivudine\"> </a><a name=\"ingredient-for-dovato-lamivudine-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/2T8Q726O95 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#ManufacturedItemDefinition_mid-49178f16170ee8a6bc2a4361c1748d5f\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#MedicinalProductDefinition_mp16598f252d07b4784b82ba43cf9e847e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#AdministrableProductDefinition_ap-49178f16170ee8a6bc2a4361c1748d5f\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072072}\">Active</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 2T8Q726O95}\">lamivudine</span></td></tr></table><h3>Strengths</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style=\"display: none\">*</td><td>300 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM  codemg = 'mg')</span></td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}\">active ingredient - basis of strength</span></td></tr></table></blockquote></div>"
  ] ; # 
  fhir:identifier [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2T8Q726O95" ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:for ( [
fhir:reference [ fhir:v "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f" ]
  ] [
fhir:reference [ fhir:v "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e" ]
  ] [
fhir:reference [ fhir:v "AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f" ]
  ] ) ; # 
  fhir:role [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000072072" ] ;
fhir:display [ fhir:v "Active" ]     ] )
  ] ; # 
  fhir:substance [
fhir:code [
fhir:concept [
        ( fhir:coding [
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ;
fhir:code [ fhir:v "2T8Q726O95" ] ;
fhir:display [ fhir:v "lamivudine" ]         ] )       ]     ] ;
    ( fhir:strength [
fhir:presentation [
a fhir:Quantity ;
fhir:value [ fhir:v "300"^^xsd:decimal ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "mg" ]       ] ;
fhir:basis [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v3-RoleClass"^^xsd:anyURI ] ;
fhir:code [ fhir:v "ACTIB" ] ;
fhir:display [ fhir:v "active ingredient - basis of strength" ]         ] )       ]     ] )
  ] . # 

<http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-microcrystallinecellulose> a fhir:Ingredient ;
  fhir:id [ fhir:v "ingredient-for-dovato-microcrystallinecellulose"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-dovato-microcrystallinecellulose\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-for-dovato-microcrystallinecellulose</b></p><a name=\"ingredient-for-dovato-microcrystallinecellulose\"> </a><a name=\"hcingredient-for-dovato-microcrystallinecellulose\"> </a><a name=\"ingredient-for-dovato-microcrystallinecellulose-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/OP1R32D61U (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#ManufacturedItemDefinition_mid-49178f16170ee8a6bc2a4361c1748d5f\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#MedicinalProductDefinition_mp16598f252d07b4784b82ba43cf9e847e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#AdministrableProductDefinition_ap-49178f16170ee8a6bc2a4361c1748d5f\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072082}\">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta OP1R32D61U}\">microcrystalline cellulose</span></td></tr></table></blockquote></div>"
  ] ; # 
  fhir:identifier [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ;
fhir:value [ fhir:v "OP1R32D61U" ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:for ( [
fhir:reference [ fhir:v "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f" ]
  ] [
fhir:reference [ fhir:v "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e" ]
  ] [
fhir:reference [ fhir:v "AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f" ]
  ] ) ; # 
  fhir:role [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000072082" ] ;
fhir:display [ fhir:v "Excipient" ]     ] )
  ] ; # 
  fhir:substance [
fhir:code [
fhir:concept [
        ( fhir:coding [
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ;
fhir:code [ fhir:v "OP1R32D61U" ] ;
fhir:display [ fhir:v "microcrystalline cellulose" ]         ] )       ]     ]
  ] . # 

<http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-sodiumstarchglycolate> a fhir:Ingredient ;
  fhir:id [ fhir:v "ingredient-for-dovato-sodiumstarchglycolate"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-dovato-sodiumstarchglycolate\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-for-dovato-sodiumstarchglycolate</b></p><a name=\"ingredient-for-dovato-sodiumstarchglycolate\"> </a><a name=\"hcingredient-for-dovato-sodiumstarchglycolate\"> </a><a name=\"ingredient-for-dovato-sodiumstarchglycolate-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/H8AV0SQX4D (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#ManufacturedItemDefinition_mid-49178f16170ee8a6bc2a4361c1748d5f\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#MedicinalProductDefinition_mp16598f252d07b4784b82ba43cf9e847e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#AdministrableProductDefinition_ap-49178f16170ee8a6bc2a4361c1748d5f\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072082}\">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta H8AV0SQX4D}\">sodium starch glycolate</span></td></tr></table></blockquote></div>"
  ] ; # 
  fhir:identifier [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ;
fhir:value [ fhir:v "H8AV0SQX4D" ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:for ( [
fhir:reference [ fhir:v "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f" ]
  ] [
fhir:reference [ fhir:v "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e" ]
  ] [
fhir:reference [ fhir:v "AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f" ]
  ] ) ; # 
  fhir:role [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000072082" ] ;
fhir:display [ fhir:v "Excipient" ]     ] )
  ] ; # 
  fhir:substance [
fhir:code [
fhir:concept [
        ( fhir:coding [
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ;
fhir:code [ fhir:v "H8AV0SQX4D" ] ;
fhir:display [ fhir:v "sodium starch glycolate" ]         ] )       ]     ]
  ] . # 

<http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-magnesiumstearate> a fhir:Ingredient ;
  fhir:id [ fhir:v "ingredient-for-dovato-magnesiumstearate"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-dovato-magnesiumstearate\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-for-dovato-magnesiumstearate</b></p><a name=\"ingredient-for-dovato-magnesiumstearate\"> </a><a name=\"hcingredient-for-dovato-magnesiumstearate\"> </a><a name=\"ingredient-for-dovato-magnesiumstearate-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/70097M6I30 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#ManufacturedItemDefinition_mid-49178f16170ee8a6bc2a4361c1748d5f\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#MedicinalProductDefinition_mp16598f252d07b4784b82ba43cf9e847e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#AdministrableProductDefinition_ap-49178f16170ee8a6bc2a4361c1748d5f\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072082}\">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 70097M6I30}\">magnesium stearate</span></td></tr></table></blockquote></div>"
  ] ; # 
  fhir:identifier [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ;
fhir:value [ fhir:v "70097M6I30" ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:for ( [
fhir:reference [ fhir:v "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f" ]
  ] [
fhir:reference [ fhir:v "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e" ]
  ] [
fhir:reference [ fhir:v "AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f" ]
  ] ) ; # 
  fhir:role [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000072082" ] ;
fhir:display [ fhir:v "Excipient" ]     ] )
  ] ; # 
  fhir:substance [
fhir:code [
fhir:concept [
        ( fhir:coding [
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ;
fhir:code [ fhir:v "70097M6I30" ] ;
fhir:display [ fhir:v "magnesium stearate" ]         ] )       ]     ]
  ] . # 

<http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-mannitol> a fhir:Ingredient ;
  fhir:id [ fhir:v "ingredient-for-dovato-mannitol"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-dovato-mannitol\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-for-dovato-mannitol</b></p><a name=\"ingredient-for-dovato-mannitol\"> </a><a name=\"hcingredient-for-dovato-mannitol\"> </a><a name=\"ingredient-for-dovato-mannitol-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/3OWL53L36A (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#ManufacturedItemDefinition_mid-49178f16170ee8a6bc2a4361c1748d5f\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#MedicinalProductDefinition_mp16598f252d07b4784b82ba43cf9e847e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#AdministrableProductDefinition_ap-49178f16170ee8a6bc2a4361c1748d5f\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072082}\">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 3OWL53L36A}\">mannitol</span></td></tr></table></blockquote></div>"
  ] ; # 
  fhir:identifier [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ;
fhir:value [ fhir:v "3OWL53L36A" ]
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:for ( [
fhir:reference [ fhir:v "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f" ]
  ] [
fhir:reference [ fhir:v "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e" ]
  ] [
fhir:reference [ fhir:v "AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f" ]
  ] ) ; # 
  fhir:role [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000072082" ] ;
fhir:display [ fhir:v "Excipient" ]     ] )
  ] ; # 
  fhir:substance [
fhir:code [
fhir:concept [
        ( fhir:coding [
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta"^^xsd:anyURI ] ;
fhir:code [ fhir:v "3OWL53L36A" ] ;
fhir:display [ fhir:v "mannitol" ]         ] )       ]     ]
  ] . # 

<http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-dolutegravirsodium> a fhir:SubstanceDefinition ;
  fhir:id [ fhir:v "substance-dolutegravirsodium"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_substance-dolutegravirsodium\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition substance-dolutegravirsodium</b></p><a name=\"substance-dolutegravirsodium\"> </a><a name=\"hcsubstance-dolutegravirsodium\"> </a><a name=\"substance-dolutegravirsodium-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/1Q1V9V5WYQ (use: official, )</p><p><b>version</b>: 1</p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>manufacturer</b>: <a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#Organization_man-173fde4cb6b1018cb7ec8ab708d3961c\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><h3>MolecularWeights</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Amount</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">exact</span></td><td>441.36</td></tr></table><h3>Structures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>MolecularFormula</b></td></tr><tr><td style=\"display: none\">*</td><td>C20H18F2N305.Na</td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>(4R,12.ALPHA.S)-N-((2,4-DIFLUOROPHENYL)METHYL)-7-HYDROXY-4-METHYL-6,8-DIOXO-3,4,6,8,12,12.ALPHA.-HEXAHYDRO-2H-PYRIDO(1',2':4,5)PYRAZINO(2,1-.BETA.)(1,3)OXAZINE-9-CARBOXAMIDE</td><td><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta/ x}\">Chemical Name</span></td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta/"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1Q1V9V5WYQ" ]
  ] ) ; # 
  fhir:version [ fhir:v "1"] ; # 
  fhir:status [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "active" ]     ] )
  ] ; # 
  fhir:manufacturer ( [
fhir:reference [ fhir:v "Organization/man-173fde4cb6b1018cb7ec8ab708d3961c" ]
  ] ) ; # 
  fhir:molecularWeight ( [
fhir:type [
fhir:text [ fhir:v "exact" ]     ] ;
fhir:amount [
fhir:value [ fhir:v "441.36"^^xsd:decimal ]     ]
  ] ) ; # 
  fhir:structure [
fhir:molecularFormula [ fhir:v "C20H18F2N305.Na" ]
  ] ; # 
  fhir:name ( [
fhir:name [ fhir:v "(4R,12.ALPHA.S)-N-((2,4-DIFLUOROPHENYL)METHYL)-7-HYDROXY-4-METHYL-6,8-DIOXO-3,4,6,8,12,12.ALPHA.-HEXAHYDRO-2H-PYRIDO(1',2':4,5)PYRAZINO(2,1-.BETA.)(1,3)OXAZINE-9-CARBOXAMIDE" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "x" ] ;
fhir:display [ fhir:v "Chemical Name" ]       ] )     ]
  ] ) . # 

<http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-lamivudine> a fhir:SubstanceDefinition ;
  fhir:id [ fhir:v "substance-lamivudine"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_substance-lamivudine\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition substance-lamivudine</b></p><a name=\"substance-lamivudine\"> </a><a name=\"hcsubstance-lamivudine\"> </a><a name=\"substance-lamivudine-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/2T8Q726O95 (use: official, )</p><p><b>version</b>: 1</p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>manufacturer</b>: <a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#Organization_man-173fde4cb6b1018cb7ec8ab708d3961c\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><h3>MolecularWeights</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Amount</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">exact</span></td><td>229.26</td></tr></table><h3>Structures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>MolecularFormula</b></td></tr><tr><td style=\"display: none\">*</td><td>C8H11N303S</td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>(-)-1-((2R,5S)-2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL)CYTOSINE</td><td><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta/ x}\">Chemical Name</span></td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta/"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2T8Q726O95" ]
  ] ) ; # 
  fhir:version [ fhir:v "1"] ; # 
  fhir:status [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "active" ]     ] )
  ] ; # 
  fhir:manufacturer ( [
fhir:reference [ fhir:v "Organization/man-173fde4cb6b1018cb7ec8ab708d3961c" ]
  ] ) ; # 
  fhir:molecularWeight ( [
fhir:type [
fhir:text [ fhir:v "exact" ]     ] ;
fhir:amount [
fhir:value [ fhir:v "229.26"^^xsd:decimal ]     ]
  ] ) ; # 
  fhir:structure [
fhir:molecularFormula [ fhir:v "C8H11N303S" ]
  ] ; # 
  fhir:name ( [
fhir:name [ fhir:v "(-)-1-((2R,5S)-2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL)CYTOSINE" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "https://gsrs.ncats.nih.gov/ginas/app/beta/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "x" ] ;
fhir:display [ fhir:v "Chemical Name" ]       ] )     ]
  ] ) . # 

<http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f> a fhir:AdministrableProductDefinition ;
  fhir:id [ fhir:v "ap-49178f16170ee8a6bc2a4361c1748d5f"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"AdministrableProductDefinition_ap-49178f16170ee8a6bc2a4361c1748d5f\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition ap-49178f16170ee8a6bc2a4361c1748d5f</b></p><a name=\"ap-49178f16170ee8a6bc2a4361c1748d5f\"> </a><a name=\"hcap-49178f16170ee8a6bc2a4361c1748d5f\"> </a><a name=\"ap-49178f16170ee8a6bc2a4361c1748d5f-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/123456</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#MedicinalProductDefinition_mp16598f252d07b4784b82ba43cf9e847e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>administrableDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073664}\">Tablet</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000002152}\">Tablet</span></p><p><b>producedFrom</b>: <a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#ManufacturedItemDefinition_mid-49178f16170ee8a6bc2a4361c1748d5f\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073619}\">Oral use</span></p><h3>TargetSpecies</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000109093}\">Human</span></td></tr></table></blockquote></div>"
  ] ; # 
  fhir:identifier ( [
fhir:system [ fhir:v "https://spor.ema.europa.eu/pmswi"^^xsd:anyURI ] ;
fhir:value [ fhir:v "123456" ]
  ] ) ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:formOf ( [
fhir:reference [ fhir:v "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e" ]
  ] ) ; # 
  fhir:administrableDoseForm [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000073664" ] ;
fhir:display [ fhir:v "Tablet" ]     ] )
  ] ; # 
  fhir:unitOfPresentation [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "200000002152" ] ;
fhir:display [ fhir:v "Tablet" ]     ] )
  ] ; # 
  fhir:producedFrom ( [
fhir:reference [ fhir:v "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f" ]
  ] ) ; # 
  fhir:routeOfAdministration ( [
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000073619" ] ;
fhir:display [ fhir:v "Oral use" ]       ] )     ] ;
    ( fhir:targetSpecies [
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000109093" ] ;
fhir:display [ fhir:v "Human" ]         ] )       ]     ] )
  ] ) . # 

<http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization49178f16170ee8a6bc2a4361c1748d5f0> a fhir:RegulatedAuthorization ;
  fhir:id [ fhir:v "authorization49178f16170ee8a6bc2a4361c1748d5f0"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_authorization49178f16170ee8a6bc2a4361c1748d5f0\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization authorization49178f16170ee8a6bc2a4361c1748d5f0</b></p><a name=\"authorization49178f16170ee8a6bc2a4361c1748d5f0\"> </a><a name=\"hcauthorization49178f16170ee8a6bc2a4361c1748d5f0\"> </a><a name=\"authorization49178f16170ee8a6bc2a4361c1748d5f0-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/19/1370/001 (use: official, )</p><p><b>subject</b>: <a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#MedicinalProductDefinition_mp16598f252d07b4784b82ba43cf9e847e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 220000000061}\">Marketing Authorisation</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>statusDate</b>: 2019-07-01 13:28:17+0000</p><p><b>holder</b>: <a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#Organization_mah-31ff1af739c7dcf77386a86f8dd83d29\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>regulator</b>: <a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#Organization_mra-7c9b97127f73ff3605a10eb1c2cc24d1\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>"
  ] ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://spor.ema.europa.eu/pmswi"^^xsd:anyURI ] ;
fhir:value [ fhir:v "EU/1/19/1370/001" ]
  ] ) ; # 
  fhir:subject ( [
fhir:reference [ fhir:v "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e" ]
  ] ) ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "220000000061" ] ;
fhir:display [ fhir:v "Marketing Authorisation" ]     ] )
  ] ; # 
  fhir:status [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "active" ] ;
fhir:display [ fhir:v "Active" ]     ] )
  ] ; # 
  fhir:statusDate [ fhir:v "2019-07-01T13:28:17Z"^^xsd:dateTime] ; # 
  fhir:holder [
fhir:reference [ fhir:v "Organization/mah-31ff1af739c7dcf77386a86f8dd83d29" ]
  ] ; # 
  fhir:regulator [
fhir:reference [ fhir:v "Organization/mra-7c9b97127f73ff3605a10eb1c2cc24d1" ]
  ] . # 

<http://hl7.eu/fhir/ig/gravitate-health/Organization/man-173fde4cb6b1018cb7ec8ab708d3961c> a fhir:Organization ;
  fhir:id [ fhir:v "man-173fde4cb6b1018cb7ec8ab708d3961c"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_man-173fde4cb6b1018cb7ec8ab708d3961c\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization man-173fde4cb6b1018cb7ec8ab708d3961c</b></p><a name=\"man-173fde4cb6b1018cb7ec8ab708d3961c\"> </a><a name=\"hcman-173fde4cb6b1018cb7ec8ab708d3961c\"> </a><a name=\"man-173fde4cb6b1018cb7ec8ab708d3961c-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/ORG-100004538 (use: official, )</p><p><b>active</b>: true</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 220000000033}\">Manufacturer</span></p><p><b>name</b>: GLAXO WELLCOME, S.A.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Avda. Extremadura 3, 09400 Aranda De Duero Aranda De Duero ES(work)</td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://spor.ema.europa.eu/omswi"^^xsd:anyURI ] ;
fhir:value [ fhir:v "ORG-100004538" ]
  ] ) ; # 
  fhir:active [ fhir:v "true"^^xsd:boolean] ; # 
  fhir:type ( [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "220000000033" ] ;
fhir:display [ fhir:v "Manufacturer" ]     ] )
  ] ) ; # 
  fhir:name [ fhir:v "GLAXO WELLCOME, S.A."] ; # 
  fhir:contact ( [
fhir:address [
fhir:use [ fhir:v "work" ] ;
fhir:type [ fhir:v "physical" ] ;
fhir:text [ fhir:v "Avda. Extremadura 3, 09400 Aranda De Duero Aranda De Duero ES" ] ;
      ( fhir:line [ fhir:v "Avda. Extremadura 3, 09400 Aranda De Duero" ] ) ;
fhir:city [ fhir:v "Aranda De Duero" ] ;
fhir:country [ fhir:v "ES" ]     ]
  ] ) . # 

<http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-31ff1af739c7dcf77386a86f8dd83d29> a fhir:Organization ;
  fhir:id [ fhir:v "mah-31ff1af739c7dcf77386a86f8dd83d29"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_mah-31ff1af739c7dcf77386a86f8dd83d29\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization mah-31ff1af739c7dcf77386a86f8dd83d29</b></p><a name=\"mah-31ff1af739c7dcf77386a86f8dd83d29\"> </a><a name=\"hcmah-31ff1af739c7dcf77386a86f8dd83d29\"> </a><a name=\"mah-31ff1af739c7dcf77386a86f8dd83d29-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/ORG-100012958 (use: official, )</p><p><b>active</b>: true</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 220000000034}\">Marketing authorisation holder</span></p><p><b>name</b>: ViiV Healthcare BV</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Van Asch van Wijckstraat 55H Amersfoort NL(work)</td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://spor.ema.europa.eu/omswi"^^xsd:anyURI ] ;
fhir:value [ fhir:v "ORG-100012958" ]
  ] ) ; # 
  fhir:active [ fhir:v "true"^^xsd:boolean] ; # 
  fhir:type ( [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "220000000034" ] ;
fhir:display [ fhir:v "Marketing authorisation holder" ]     ] )
  ] ) ; # 
  fhir:name [ fhir:v "ViiV Healthcare BV"] ; # 
  fhir:contact ( [
fhir:address [
fhir:use [ fhir:v "work" ] ;
fhir:type [ fhir:v "physical" ] ;
fhir:text [ fhir:v "Van Asch van Wijckstraat 55H Amersfoort NL" ] ;
      ( fhir:line [ fhir:v "Van Asch van Wijckstraat 55H" ] ) ;
fhir:city [ fhir:v "Amersfoort" ] ;
fhir:country [ fhir:v "NL" ]     ]
  ] ) . # 

<http://hl7.eu/fhir/ig/gravitate-health/Organization/mra-7c9b97127f73ff3605a10eb1c2cc24d1> a fhir:Organization ;
  fhir:id [ fhir:v "mra-7c9b97127f73ff3605a10eb1c2cc24d1"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_mra-7c9b97127f73ff3605a10eb1c2cc24d1\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization mra-7c9b97127f73ff3605a10eb1c2cc24d1</b></p><a name=\"mra-7c9b97127f73ff3605a10eb1c2cc24d1\"> </a><a name=\"hcmra-7c9b97127f73ff3605a10eb1c2cc24d1\"> </a><a name=\"mra-7c9b97127f73ff3605a10eb1c2cc24d1-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/ORG-100013412 (use: official, )</p><p><b>active</b>: true</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 220000000032}\">Medicines Regulatory Authority</span></p><p><b>name</b>: European Medicines Agency</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Carretera De Martorell 41 61, Poligono Industrial Nord-Est Amsterdam NL(work)</td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://spor.ema.europa.eu/omswi"^^xsd:anyURI ] ;
fhir:value [ fhir:v "ORG-100013412" ]
  ] ) ; # 
  fhir:active [ fhir:v "true"^^xsd:boolean] ; # 
  fhir:type ( [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "220000000032" ] ;
fhir:display [ fhir:v "Medicines Regulatory Authority" ]     ] )
  ] ) ; # 
  fhir:name [ fhir:v "European Medicines Agency"] ; # 
  fhir:contact ( [
fhir:address [
fhir:use [ fhir:v "work" ] ;
fhir:type [ fhir:v "physical" ] ;
fhir:text [ fhir:v "Carretera De Martorell 41 61, Poligono Industrial Nord-Est Amsterdam NL" ] ;
      ( fhir:line [ fhir:v "Carretera De Martorell 41 61, Poligono Industrial Nord-Est" ] ) ;
fhir:city [ fhir:v "Amsterdam" ] ;
fhir:postalCode [ fhir:v "1083 HS" ] ;
fhir:country [ fhir:v "NL" ]     ]
  ] ) . # 

<http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-2977a2afce16a0bd914b8d242dd126b5> a fhir:PackagedProductDefinition ;
  fhir:id [ fhir:v "ppd-2977a2afce16a0bd914b8d242dd126b5"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_ppd-2977a2afce16a0bd914b8d242dd126b5\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition ppd-2977a2afce16a0bd914b8d242dd126b5</b></p><a name=\"ppd-2977a2afce16a0bd914b8d242dd126b5\"> </a><a name=\"hcppd-2977a2afce16a0bd914b8d242dd126b5\"> </a><a name=\"ppd-2977a2afce16a0bd914b8d242dd126b5-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/19/1370/001 (use: official, )</p><p><b>name</b>: Dovato 50 mg/300 mg film-coated tablets 30</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000155527}\">Chemical Medicinal Product</span></p><p><b>packageFor</b>: <a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#MedicinalProductDefinition_mp16598f252d07b4784b82ba43cf9e847e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>statusDate</b>: 2012-02-07 13:28:17+0000</p><p><b>manufacturer</b>: <a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#Organization_man-173fde4cb6b1018cb7ec8ab708d3961c\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073498}\">Box</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000003529}\">Cardboard</span></p><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/123456</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073504}\">Child-resistant closure</span></p><p><b>quantity</b>: 30</p><p><b>material</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 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-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#ManufacturedItemDefinition_mid-49178f16170ee8a6bc2a4361c1748d5f\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></td></tr></table></blockquote></blockquote></blockquote></div>"
  ] ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://spor.ema.europa.eu/pmswi"^^xsd:anyURI ] ;
fhir:value [ fhir:v "EU/1/19/1370/001" ]
  ] ) ; # 
  fhir:name [ fhir:v "Dovato 50 mg/300 mg film-coated tablets 30"] ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000155527" ] ;
fhir:display [ fhir:v "Chemical Medicinal Product" ]     ] )
  ] ; # 
  fhir:packageFor ( [
fhir:reference [ fhir:v "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e" ]
  ] ) ; # 
  fhir:status [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "active" ] ;
fhir:display [ fhir:v "Active" ]     ] )
  ] ; # 
  fhir:statusDate [ fhir:v "2012-02-07T13:28:17Z"^^xsd:dateTime] ; # 
  fhir:manufacturer ( [
fhir:reference [ fhir:v "Organization/man-173fde4cb6b1018cb7ec8ab708d3961c" ]
  ] ) ; # 
  fhir:packaging [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000073498" ] ;
fhir:display [ fhir:v "Box" ]       ] )     ] ;
fhir:quantity [ fhir:v "1"^^xsd:integer ] ;
    ( fhir:material [
      ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "200000003529" ] ;
fhir:display [ fhir:v "Cardboard" ]       ] )     ] ) ;
    ( fhir:packaging [
      ( fhir:identifier [
fhir:system [ fhir:v "https://spor.ema.europa.eu/pmswi"^^xsd:anyURI ] ;
fhir:value [ fhir:v "123456" ]       ] ) ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000073504" ] ;
fhir:display [ fhir:v "Child-resistant closure" ]         ] )       ] ;
fhir:quantity [ fhir:v "30"^^xsd:integer ] ;
      ( fhir:material [
        ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "200000003203" ] ;
fhir:display [ fhir:v "Glass" ]         ] )       ] ) ;
      ( fhir:containedItem [
fhir:item [
fhir:reference [
fhir:reference [ fhir:v "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f" ]           ]         ]       ] )     ] )
  ] . # 

<http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e> a fhir:MedicinalProductDefinition ;
  fhir:id [ fhir:v "mp16598f252d07b4784b82ba43cf9e847e"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mp16598f252d07b4784b82ba43cf9e847e\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mp16598f252d07b4784b82ba43cf9e847e</b></p><a name=\"mp16598f252d07b4784b82ba43cf9e847e\"> </a><a name=\"hcmp16598f252d07b4784b82ba43cf9e847e\"> </a><a name=\"mp16598f252d07b4784b82ba43cf9e847e-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/19/1370/001, <code>https://www.who-umc.org/phpid</code>/0x073AF2E5B92AE19E8B67635AFFB3D6CA</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}\">Medicinal Product</span></p><p><b>domain</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-domain Human}\">Human use</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">active</span></p><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072084}\">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Dovato 50 mg/300 mg film-coated tablets</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}\">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: Dovato</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: dolutegravir/lamivudine</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}\">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 50 mg/300 mg</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: film-coated tablets</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}\">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 GBR}\">United Kingdom</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 GBR}\">United Kingdom</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 en}\">English</span></td></tr></table></blockquote></div>"
  ] ; # 
  fhir:identifier ( [
fhir:system [ fhir:v "https://spor.ema.europa.eu/pmswi"^^xsd:anyURI ] ;
fhir:value [ fhir:v "EU/1/19/1370/001" ]
  ] [
fhir:system [ fhir:v "https://www.who-umc.org/phpid"^^xsd:anyURI ] ;
fhir:value [ fhir:v "0x073AF2E5B92AE19E8B67635AFFB3D6CA" ]
  ] ) ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "MedicinalProduct" ] ;
fhir:display [ fhir:v "Medicinal Product" ]     ] )
  ] ; # 
  fhir:domain [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-domain"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Human" ] ;
fhir:display [ fhir:v "Human use" ]     ] )
  ] ; # 
  fhir:status [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "active" ] ;
fhir:display [ fhir:v "active" ]     ] )
  ] ; # 
  fhir:legalStatusOfSupply [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000072084" ] ;
fhir:display [ fhir:v "Medicinal product subject to medical prescription" ]     ] )
  ] ; # 
  fhir:name ( [
fhir:productName [ fhir:v "Dovato 50 mg/300 mg film-coated tablets" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ;
fhir:code [ fhir:v "220000000001" ] ;
fhir:display [ fhir:v "Full name" ]       ] )     ] ;
    ( fhir:part [
fhir:part [ fhir:v "Dovato" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ;
fhir:code [ fhir:v "220000000002" ] ;
fhir:display [ fhir:v "Invented name part" ]         ] )       ]     ] [
fhir:part [ fhir:v "dolutegravir/lamivudine" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ;
fhir:code [ fhir:v "220000000003" ] ;
fhir:display [ fhir:v "Scientific name part" ]         ] )       ]     ] [
fhir:part [ fhir:v "50 mg/300 mg" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ;
fhir:code [ fhir:v "220000000004" ] ;
fhir:display [ fhir:v "Strength part" ]         ] )       ]     ] [
fhir:part [ fhir:v "film-coated tablets" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ;
fhir:code [ fhir:v "220000000005" ] ;
fhir:display [ fhir:v "Pharmaceutical dose form part" ]         ] )       ]     ] ) ;
    ( fhir:usage [
fhir:country [
        ( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "GBR" ] ;
fhir:display [ fhir:v "United Kingdom" ]         ] )       ] ;
fhir:jurisdiction [
        ( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "GBR" ] ;
fhir:display [ fhir:v "United Kingdom" ]         ] )       ] ;
fhir:language [
        ( fhir:coding [
fhir:system [ fhir:v "urn:ietf:bcp:47"^^xsd:anyURI ] ;
fhir:code [ fhir:v "en" ] ;
fhir:display [ fhir:v "English" ]         ] )       ]     ] )
  ] ) . # 

<http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f> a fhir:ManufacturedItemDefinition ;
  fhir:id [ fhir:v "mid-49178f16170ee8a6bc2a4361c1748d5f"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ManufacturedItemDefinition_mid-49178f16170ee8a6bc2a4361c1748d5f\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition mid-49178f16170ee8a6bc2a4361c1748d5f</b></p><a name=\"mid-49178f16170ee8a6bc2a4361c1748d5f\"> </a><a name=\"hcmid-49178f16170ee8a6bc2a4361c1748d5f\"> </a><a name=\"mid-49178f16170ee8a6bc2a4361c1748d5f-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/19/1370/001 (use: official, )</p><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi/ 100000073665}\">Film-coated tablet</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000002152}\">Tablet</span></p><p><b>manufacturer</b>: <a href=\"Bundle-bundlepackageleaflet-da-49178f16170ee8a6bc2a4361c1748d5f.html#Organization_man-173fde4cb6b1018cb7ec8ab708d3961c\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/19/1370/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>"
  ] ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://spor.ema.europa.eu/pmswi"^^xsd:anyURI ] ;
fhir:value [ fhir:v "EU/1/19/1370/001" ]
  ] ) ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:manufacturedDoseForm [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000073665" ] ;
fhir:display [ fhir:v "Film-coated tablet" ]     ] )
  ] ; # 
  fhir:unitOfPresentation [
    ( fhir:coding [
fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ;
fhir:code [ fhir:v "200000002152" ] ;
fhir:display [ fhir:v "Tablet" ]     ] )
  ] ; # 
  fhir:manufacturer ( [
fhir:reference [ fhir:v "Organization/man-173fde4cb6b1018cb7ec8ab708d3961c" ]
  ] ) . #