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

: [Enhanced-Alicia] ePI document for Dovato 50 mg/300 mg tablets Package Leaflet ES - JSON Representation

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  "timestamp" : "2023-04-25T11:55:27Z",
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          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"es\" lang=\"es\"><a name=\"Composition_compositione722f6782d3f34f86982e14386c8811dgg\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition compositione722f6782d3f34f86982e14386c8811dgg</b></p><a name=\"compositione722f6782d3f34f86982e14386c8811dgg\"> </a><a name=\"hccompositione722f6782d3f34f86982e14386c8811dgg\"> </a><a name=\"compositione722f6782d3f34f86982e14386c8811dgg-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>https://spor.ema.europa.eu/rmswi/</code>/yy</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>date</b>: 2022-04-29 13:28:17+0000</p><p><b>author</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><p><b>title</b>: TEST PURPOSES ONLY - Dovato 50 mg/300 mg comprimidos recubiertos con película</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 comprimidos recubiertos con película",
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            "section" : [
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                "title" : "Package leaflet: Information for the user",
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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" : "What is in this leaflet",
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                  "status" : "additional",
                  "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. What Dovato 50 mg/300 mg comprimidos recubiertos con película is and what it is used for",
                "code" : {
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                    {
                      "system" : "https://spor.ema.europa.eu/rmswi/",
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                  ],
                  "text" : "1. What Dovato 50 mg/300 mg comprimidos recubiertos con película is and what it is used for"
                },
                "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. What you need to know before you take Dovato 50 mg/300 mg comprimidos recubiertos con película",
                "code" : {
                  "coding" : [
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                  "text" : "2. What you need to know before you take Dovato 50 mg/300 mg comprimidos recubiertos con película"
                },
                "text" : {
                  "status" : "additional",
                  "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>2. Qué necesita saber antes de empezar a tomar Dovato</b> <b>No tome Dovato</b><ul><li>si es <b>alérgico</b> (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 <b>fampridina</b> (también conocido como dalfampridina; utilizado para tratar la esclerosis múltiple).</li></ul></div>"
                }
              },
              {
                "title" : "3. How to take Dovato 50 mg/300 mg comprimidos recubiertos con película",
                "code" : {
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                  "text" : "3. How to take Dovato 50 mg/300 mg comprimidos recubiertos con película"
                },
                "text" : {
                  "status" : "additional",
                  "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. Possible side effects",
                "code" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/rmswi/",
                      "code" : "100000155538"
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                  ],
                  "text" : "4. Possible side effects"
                },
                "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. How to store Dovato 50 mg/300 mg comprimidos recubiertos con película",
                "code" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/rmswi/",
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                  ],
                  "text" : "5. How to store Dovato 50 mg/300 mg comprimidos recubiertos con película"
                },
                "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>"
                }
              },
              {
                "title" : "6. Contents of the pack and other information",
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                  "text" : "6. Contents of the pack and other information"
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                  "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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        "id" : "ingredient-for-dovato-microcrystallinecellulose",
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          "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"
                }
              ]
            }
          }
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-dolutegravirsodium",
      "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"
          }
        ],
        "version" : "1",
        "status" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/publication-status",
              "code" : "active"
            }
          ]
        },
        "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"
                }
              ]
            }
          }
        ]
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-lamivudine",
      "resource" : {
        "resourceType" : "SubstanceDefinition",
        "id" : "substance-lamivudine",
        "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" : [
          {
            "use" : "official",
            "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
            "value" : "2T8Q726O95"
          }
        ],
        "version" : "1",
        "status" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/publication-status",
              "code" : "active"
            }
          ]
        },
        "manufacturer" : [
          {
            "reference" : "Organization/man-173fde4cb6b1018cb7ec8ab708d3961c"
          }
        ],
        "molecularWeight" : [
          {
            "type" : {
              "text" : "exact"
            },
            "amount" : {
              "value" : 229.26
            }
          }
        ],
        "structure" : {
          "molecularFormula" : "C8H11N303S"
        },
        "name" : [
          {
            "name" : "(-)-1-((2R,5S)-2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL)CYTOSINE",
            "type" : {
              "coding" : [
                {
                  "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
                  "code" : "x",
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            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"
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        "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>"
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              {
                "part" : "50 mg/300 mg",
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              {
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              {
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                "language" : {
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    {
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            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"
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          "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>"
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}