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

: ePI document Bundle for Dovato 50 mg/300 mg film-coated tablets Package Leaflet for language es - JSON Representation

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          "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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        "author" : [
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        "title" : "TEST PURPOSES ONLY - Dovato 50 mg/300 mg film-coated tablets",
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            "title" : "B. PROSPECTO",
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              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
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                "title" : "PROSPECTO: INFORMACIÓN PARA EL USUARIO",
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                  "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>"
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                "title" : "Contenido del prospecto",
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                  "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>"
                }
              },
              {
                "title" : "1. Qué es Dovato y para qué se utiliza",
                "code" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/rmswi/",
                      "code" : "100000155538"
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                  "text" : "1. Qué es Dovato y para qué se utiliza"
                },
                "text" : {
                  "status" : "additional",
                  "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>"
                }
              },
              {
                "title" : "2. Qué necesita saber antes de empezar a tomar Dovato",
                "code" : {
                  "coding" : [
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                      "system" : "https://spor.ema.europa.eu/rmswi/",
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                  "text" : "2. Qué necesita saber antes de empezar a tomar Dovato"
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                  "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>"
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                "title" : "3. Cómo tomar Dovato",
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                  "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>"
                }
              },
              {
                "title" : "4. Posibles efectos adversos",
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                  "text" : "4. Posibles efectos adversos"
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                "text" : {
                  "status" : "additional",
                  "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>"
                }
              },
              {
                "title" : "5. Conservación de Dovato",
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                  "text" : "5. Conservación de Dovato"
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                "text" : {
                  "status" : "additional",
                  "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>"
                }
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              {
                "title" : "6. Contenido del envase e información adicional",
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                  "text" : "6. Contenido del envase e información adicional"
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                "text" : {
                  "status" : "additional",
                  "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>"
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              "basis" : {
                "coding" : [
                  {
                    "system" : "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
                    "code" : "ACTIB",
                    "display" : "active ingredient - basis of strength"
                  }
                ]
              }
            }
          ]
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-lamivudine",
      "resource" : {
        "resourceType" : "Ingredient",
        "id" : "ingredient-for-dovato-lamivudine",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "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\u00a0(use:\u00a0official,\u00a0)</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>"
        },
        "identifier" : {
          "use" : "official",
          "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
          "value" : "2T8Q726O95"
        },
        "status" : "active",
        "for" : [
          {
            "reference" : "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f"
          },
          {
            "reference" : "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e"
          },
          {
            "reference" : "AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f"
          }
        ],
        "role" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072072",
              "display" : "Active"
            }
          ]
        },
        "substance" : {
          "code" : {
            "concept" : {
              "coding" : [
                {
                  "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
                  "code" : "2T8Q726O95",
                  "display" : "lamivudine"
                }
              ]
            }
          },
          "strength" : [
            {
              "presentationQuantity" : {
                "value" : 300,
                "system" : "http://unitsofmeasure.org",
                "code" : "mg"
              },
              "basis" : {
                "coding" : [
                  {
                    "system" : "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
                    "code" : "ACTIB",
                    "display" : "active ingredient - basis of strength"
                  }
                ]
              }
            }
          ]
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-microcrystallinecellulose",
      "resource" : {
        "resourceType" : "Ingredient",
        "id" : "ingredient-for-dovato-microcrystallinecellulose",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "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\u00a0(use:\u00a0official,\u00a0)</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>"
        },
        "identifier" : {
          "use" : "official",
          "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
          "value" : "OP1R32D61U"
        },
        "status" : "active",
        "for" : [
          {
            "reference" : "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f"
          },
          {
            "reference" : "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e"
          },
          {
            "reference" : "AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f"
          }
        ],
        "role" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072082",
              "display" : "Excipient"
            }
          ]
        },
        "substance" : {
          "code" : {
            "concept" : {
              "coding" : [
                {
                  "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
                  "code" : "OP1R32D61U",
                  "display" : "microcrystalline cellulose"
                }
              ]
            }
          }
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-sodiumstarchglycolate",
      "resource" : {
        "resourceType" : "Ingredient",
        "id" : "ingredient-for-dovato-sodiumstarchglycolate",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "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\u00a0(use:\u00a0official,\u00a0)</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>"
        },
        "identifier" : {
          "use" : "official",
          "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
          "value" : "H8AV0SQX4D"
        },
        "status" : "active",
        "for" : [
          {
            "reference" : "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f"
          },
          {
            "reference" : "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e"
          },
          {
            "reference" : "AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f"
          }
        ],
        "role" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072082",
              "display" : "Excipient"
            }
          ]
        },
        "substance" : {
          "code" : {
            "concept" : {
              "coding" : [
                {
                  "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
                  "code" : "H8AV0SQX4D",
                  "display" : "sodium starch glycolate"
                }
              ]
            }
          }
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-magnesiumstearate",
      "resource" : {
        "resourceType" : "Ingredient",
        "id" : "ingredient-for-dovato-magnesiumstearate",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "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\u00a0(use:\u00a0official,\u00a0)</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>"
        },
        "identifier" : {
          "use" : "official",
          "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
          "value" : "70097M6I30"
        },
        "status" : "active",
        "for" : [
          {
            "reference" : "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f"
          },
          {
            "reference" : "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e"
          },
          {
            "reference" : "AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f"
          }
        ],
        "role" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072082",
              "display" : "Excipient"
            }
          ]
        },
        "substance" : {
          "code" : {
            "concept" : {
              "coding" : [
                {
                  "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
                  "code" : "70097M6I30",
                  "display" : "magnesium stearate"
                }
              ]
            }
          }
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-mannitol",
      "resource" : {
        "resourceType" : "Ingredient",
        "id" : "ingredient-for-dovato-mannitol",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "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\u00a0(use:\u00a0official,\u00a0)</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>"
        },
        "identifier" : {
          "use" : "official",
          "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
          "value" : "3OWL53L36A"
        },
        "status" : "active",
        "for" : [
          {
            "reference" : "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f"
          },
          {
            "reference" : "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e"
          },
          {
            "reference" : "AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f"
          }
        ],
        "role" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072082",
              "display" : "Excipient"
            }
          ]
        },
        "substance" : {
          "code" : {
            "concept" : {
              "coding" : [
                {
                  "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
                  "code" : "3OWL53L36A",
                  "display" : "mannitol"
                }
              ]
            }
          }
        }
      }
    },
    {
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      "resource" : {
        "resourceType" : "SubstanceDefinition",
        "id" : "substance-dolutegravirsodium",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "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\u00a0(use:\u00a0official,\u00a0)</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>"
        },
        "identifier" : [
          {
            "use" : "official",
            "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
            "value" : "1Q1V9V5WYQ"
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        "version" : "1",
        "status" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/publication-status",
              "code" : "active"
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          ]
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        "manufacturer" : [
          {
            "reference" : "Organization/man-173fde4cb6b1018cb7ec8ab708d3961c"
          }
        ],
        "molecularWeight" : [
          {
            "type" : {
              "text" : "exact"
            },
            "amount" : {
              "value" : 441.36
            }
          }
        ],
        "structure" : {
          "molecularFormula" : "C20H18F2N305.Na"
        },
        "name" : [
          {
            "name" : "(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" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
                  "code" : "x",
                  "display" : "Chemical Name"
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              ]
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          }
        ]
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-lamivudine",
      "resource" : {
        "resourceType" : "SubstanceDefinition",
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        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "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\u00a0(use:\u00a0official,\u00a0)</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>"
        },
        "identifier" : [
          {
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            "value" : "2T8Q726O95"
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        "version" : "1",
        "status" : {
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            {
              "system" : "http://hl7.org/fhir/publication-status",
              "code" : "active"
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        "manufacturer" : [
          {
            "reference" : "Organization/man-173fde4cb6b1018cb7ec8ab708d3961c"
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        ],
        "molecularWeight" : [
          {
            "type" : {
              "text" : "exact"
            },
            "amount" : {
              "value" : 229.26
            }
          }
        ],
        "structure" : {
          "molecularFormula" : "C8H11N303S"
        },
        "name" : [
          {
            "name" : "(-)-1-((2R,5S)-2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL)CYTOSINE",
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                {
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                  "code" : "x",
                  "display" : "Chemical Name"
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    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f",
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        "id" : "ap-49178f16170ee8a6bc2a4361c1748d5f",
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          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "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>"
        },
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          {
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            "value" : "123456"
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        "status" : "active",
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          {
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        "administrableDoseForm" : {
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            {
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              "display" : "Tablet"
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        "producedFrom" : [
          {
            "reference" : "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f"
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        "routeOfAdministration" : [
          {
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                {
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                    {
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                      "code" : "100000109093",
                      "display" : "Human"
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    {
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          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "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\u00a0(use:\u00a0official,\u00a0)</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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    {
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        },
        "text" : {
          "status" : "generated",
          "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\u00a0(use:\u00a0official,\u00a0)</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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    {
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    {
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        },
        "text" : {
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            ]
          }
        ],
        "name" : "European Medicines Agency",
        "contact" : [
          {
            "address" : {
              "use" : "work",
              "type" : "physical",
              "text" : "Carretera De Martorell 41 61, Poligono Industrial Nord-Est Amsterdam NL",
              "line" : [
                "Carretera De Martorell 41 61, Poligono Industrial Nord-Est"
              ],
              "city" : "Amsterdam",
              "postalCode" : "1083 HS",
              "country" : "NL"
            }
          }
        ]
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-2977a2afce16a0bd914b8d242dd126b5",
      "resource" : {
        "resourceType" : "PackagedProductDefinition",
        "id" : "ppd-2977a2afce16a0bd914b8d242dd126b5",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "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\u00a0(use:\u00a0official,\u00a0)</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>"
        },
        "identifier" : [
          {
            "use" : "official",
            "system" : "https://spor.ema.europa.eu/pmswi",
            "value" : "EU/1/19/1370/001"
          }
        ],
        "name" : "Dovato 50 mg/300 mg film-coated tablets 30",
        "type" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000155527",
              "display" : "Chemical Medicinal Product"
            }
          ]
        },
        "packageFor" : [
          {
            "reference" : "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e"
          }
        ],
        "status" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/publication-status",
              "code" : "active",
              "display" : "Active"
            }
          ]
        },
        "statusDate" : "2012-02-07T13:28:17Z",
        "manufacturer" : [
          {
            "reference" : "Organization/man-173fde4cb6b1018cb7ec8ab708d3961c"
          }
        ],
        "packaging" : {
          "type" : {
            "coding" : [
              {
                "system" : "https://spor.ema.europa.eu/rmswi",
                "code" : "100000073498",
                "display" : "Box"
              }
            ]
          },
          "quantity" : 1,
          "material" : [
            {
              "coding" : [
                {
                  "system" : "https://spor.ema.europa.eu/rmswi",
                  "code" : "200000003529",
                  "display" : "Cardboard"
                }
              ]
            }
          ],
          "packaging" : [
            {
              "identifier" : [
                {
                  "system" : "https://spor.ema.europa.eu/pmswi",
                  "value" : "123456"
                }
              ],
              "type" : {
                "coding" : [
                  {
                    "system" : "https://spor.ema.europa.eu/rmswi",
                    "code" : "100000073504",
                    "display" : "Child-resistant closure"
                  }
                ]
              },
              "quantity" : 30,
              "material" : [
                {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/rmswi",
                      "code" : "200000003203",
                      "display" : "Glass"
                    }
                  ]
                }
              ],
              "containedItem" : [
                {
                  "item" : {
                    "reference" : {
                      "reference" : "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f"
                    }
                  }
                }
              ]
            }
          ]
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e",
      "resource" : {
        "resourceType" : "MedicinalProductDefinition",
        "id" : "mp16598f252d07b4784b82ba43cf9e847e",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "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>"
        },
        "identifier" : [
          {
            "system" : "https://spor.ema.europa.eu/pmswi",
            "value" : "EU/1/19/1370/001"
          },
          {
            "system" : "https://www.who-umc.org/phpid",
            "value" : "0x073AF2E5B92AE19E8B67635AFFB3D6CA"
          }
        ],
        "type" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/medicinal-product-type",
              "code" : "MedicinalProduct",
              "display" : "Medicinal Product"
            }
          ]
        },
        "domain" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/medicinal-product-domain",
              "code" : "Human",
              "display" : "Human use"
            }
          ]
        },
        "status" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/publication-status",
              "code" : "active",
              "display" : "active"
            }
          ]
        },
        "legalStatusOfSupply" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072084",
              "display" : "Medicinal product subject to medical prescription"
            }
          ]
        },
        "name" : [
          {
            "productName" : "Dovato 50 mg/300 mg film-coated tablets",
            "type" : {
              "coding" : [
                {
                  "system" : "https://spor.ema.europa.eu/lists/220000000000",
                  "code" : "220000000001",
                  "display" : "Full name"
                }
              ]
            },
            "part" : [
              {
                "part" : "Dovato",
                "type" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/lists/220000000000",
                      "code" : "220000000002",
                      "display" : "Invented name part"
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                  ]
                }
              },
              {
                "part" : "dolutegravir/lamivudine",
                "type" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/lists/220000000000",
                      "code" : "220000000003",
                      "display" : "Scientific name part"
                    }
                  ]
                }
              },
              {
                "part" : "50 mg/300 mg",
                "type" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/lists/220000000000",
                      "code" : "220000000004",
                      "display" : "Strength part"
                    }
                  ]
                }
              },
              {
                "part" : "film-coated tablets",
                "type" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/lists/220000000000",
                      "code" : "220000000005",
                      "display" : "Pharmaceutical dose form part"
                    }
                  ]
                }
              }
            ],
            "usage" : [
              {
                "country" : {
                  "coding" : [
                    {
                      "system" : "urn:iso:std:iso:3166",
                      "code" : "GBR",
                      "display" : "United Kingdom"
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                  ]
                },
                "jurisdiction" : {
                  "coding" : [
                    {
                      "system" : "urn:iso:std:iso:3166",
                      "code" : "GBR",
                      "display" : "United Kingdom"
                    }
                  ]
                },
                "language" : {
                  "coding" : [
                    {
                      "system" : "urn:ietf:bcp:47",
                      "code" : "en",
                      "display" : "English"
                    }
                  ]
                }
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f",
      "resource" : {
        "resourceType" : "ManufacturedItemDefinition",
        "id" : "mid-49178f16170ee8a6bc2a4361c1748d5f",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "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\u00a0(use:\u00a0official,\u00a0)</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>"
        },
        "identifier" : [
          {
            "use" : "official",
            "system" : "https://spor.ema.europa.eu/pmswi",
            "value" : "EU/1/19/1370/001"
          }
        ],
        "status" : "active",
        "manufacturedDoseForm" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi/",
              "code" : "100000073665",
              "display" : "Film-coated tablet"
            }
          ]
        },
        "unitOfPresentation" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "200000002152",
              "display" : "Tablet"
            }
          ]
        },
        "manufacturer" : [
          {
            "reference" : "Organization/man-173fde4cb6b1018cb7ec8ab708d3961c"
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        ]
      }
    }
  ]
}