Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
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
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<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>
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<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>
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<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>
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<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>
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<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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<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>
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<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>
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<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>
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<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>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="2T8Q726O95"/>
</identifier>
<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f"/>
</for>
<for>
<reference
value="MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072072"/>
<display value="Active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="2T8Q726O95"/>
<display value="lamivudine"/>
</coding>
</concept>
</code>
<strength>
<presentationQuantity>
<value value="300"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</presentationQuantity>
<basis>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="ACTIB"/>
<display value="active ingredient - basis of strength"/>
</coding>
</basis>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-microcrystallinecellulose"/>
<resource>
<Ingredient>
<id value="ingredient-for-dovato-microcrystallinecellulose"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="OP1R32D61U"/>
</identifier>
<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f"/>
</for>
<for>
<reference
value="MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="OP1R32D61U"/>
<display value="microcrystalline cellulose"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-sodiumstarchglycolate"/>
<resource>
<Ingredient>
<id value="ingredient-for-dovato-sodiumstarchglycolate"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="H8AV0SQX4D"/>
</identifier>
<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f"/>
</for>
<for>
<reference
value="MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="H8AV0SQX4D"/>
<display value="sodium starch glycolate"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-magnesiumstearate"/>
<resource>
<Ingredient>
<id value="ingredient-for-dovato-magnesiumstearate"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="70097M6I30"/>
</identifier>
<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f"/>
</for>
<for>
<reference
value="MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="70097M6I30"/>
<display value="magnesium stearate"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-mannitol"/>
<resource>
<Ingredient>
<id value="ingredient-for-dovato-mannitol"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="3OWL53L36A"/>
</identifier>
<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f"/>
</for>
<for>
<reference
value="MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="3OWL53L36A"/>
<display value="mannitol"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-dolutegravirsodium"/>
<resource>
<SubstanceDefinition>
<id value="substance-dolutegravirsodium"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="1Q1V9V5WYQ"/>
</identifier>
<version value="1"/>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
</coding>
</status>
<manufacturer>
<reference
value="Organization/man-173fde4cb6b1018cb7ec8ab708d3961c"/>
</manufacturer>
<molecularWeight>
<type>
<text value="exact"/>
</type>
<amount>
<value value="441.36"/>
</amount>
</molecularWeight>
<structure>
<molecularFormula value="C20H18F2N305.Na"/>
</structure>
<name>
<name
value="(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"/>
<type>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<code value="x"/>
<display value="Chemical Name"/>
</coding>
</type>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-lamivudine"/>
<resource>
<SubstanceDefinition>
<id value="substance-lamivudine"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
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<display value="Chemical Name"/>
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<AdministrableProductDefinition>
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<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>
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<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>
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<meta>
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<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>
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<Organization>
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<meta>
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<text>
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<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>
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<text>
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<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>
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<meta>
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<entry>
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value="http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e"/>
<resource>
<MedicinalProductDefinition>
<id value="mp16598f252d07b4784b82ba43cf9e847e"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="EU/1/19/1370/001"/>
</identifier>
<identifier>
<system value="https://www.who-umc.org/phpid"/>
<value value="0x073AF2E5B92AE19E8B67635AFFB3D6CA"/>
</identifier>
<type>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-type"/>
<code value="MedicinalProduct"/>
<display value="Medicinal Product"/>
</coding>
</type>
<domain>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-domain"/>
<code value="Human"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="active"/>
</coding>
</status>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072084"/>
<display
value="Medicinal product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<name>
<productName value="Dovato 50 mg/300 mg film-coated tablets"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000001"/>
<display value="Full name"/>
</coding>
</type>
<part>
<part value="Dovato"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000002"/>
<display value="Invented name part"/>
</coding>
</type>
</part>
<part>
<part value="dolutegravir/lamivudine"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000003"/>
<display value="Scientific name part"/>
</coding>
</type>
</part>
<part>
<part value="50 mg/300 mg"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="film-coated tablets"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000005"/>
<display value="Pharmaceutical dose form part"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="GBR"/>
<display value="United Kingdom"/>
</coding>
</country>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="GBR"/>
<display value="United Kingdom"/>
</coding>
</jurisdiction>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="en"/>
<display value="English"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f"/>
<resource>
<ManufacturedItemDefinition>
<id value="mid-49178f16170ee8a6bc2a4361c1748d5f"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="EU/1/19/1370/001"/>
</identifier>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000073665"/>
<display value="Film-coated tablet"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000002152"/>
<display value="Tablet"/>
</coding>
</unitOfPresentation>
<manufacturer>
<reference
value="Organization/man-173fde4cb6b1018cb7ec8ab708d3961c"/>
</manufacturer>
</ManufacturedItemDefinition>
</resource>
</entry>
</Bundle>
IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.gh#0.1.0 based on FHIR 5.0.0. Generated 2024-11-20
Links: Table of Contents |
QA Report
The Gravitate Health project has received funding from the IMI 2 Joint Undertaking under grant agreement No 945334.
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.
