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-pedro] ePI document for Dovato 50 mg/300 mg tablets Package Leaflet ES - JSON Representation

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{
  "resourceType" : "Bundle",
  "id" : "enchanced-bundledovato-pedro-es",
  "meta" : {
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      🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"
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  "identifier" : {
    "system" : "https://www.gravitatehealth.eu/sid/doc",
    "value" : "EU/1/97/049/001"
  },
  "type" : "document",
  "timestamp" : "2023-04-25T11:55:27Z",
  "entry" : [
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        "resourceType" : "Composition",
        "id" : "compositione722f6782d3f34f86982e14386c8811dhh",
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        "language" : "es",
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          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"es\" lang=\"es\"><a name=\"Composition_compositione722f6782d3f34f86982e14386c8811dhh\"> </a><p><b>Generated Narrative: Composition</b><a name=\"compositione722f6782d3f34f86982e14386c8811dhh\"> </a><a name=\"hccompositione722f6782d3f34f86982e14386c8811dhh\"> </a></p><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\">ResourceComposition &quot;compositione722f6782d3f34f86982e14386c8811dhh&quot;  (Language &quot;es&quot;) </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>: Package Leaflet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000155538)</span></p><p><b>date</b>: 2022-04-29 13:28:17+0000</p><p><b>author</b>: See on this page: Organization/mra-7c9b97127f73ff3605a10eb1c2cc24d1</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>Official <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-composition-attestation-mode.html\">Composition Attestation Mode</a>#official)</span></td><td>2022-04-29 13:28:17+0000</td></tr></table></div>"
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          "text" : "Package Leaflet"
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        "subject" : [
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        "date" : "2022-04-29T13:28:17Z",
        "author" : [
          {
            "reference" : "Organization/mra-7c9b97127f73ff3605a10eb1c2cc24d1"
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        ],
        "title" : "TEST PURPOSES ONLY - Dovato 50 mg/300 mg comprimidos recubiertos con película",
        "attester" : [
          {
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        "section" : [
          {
            "title" : "B. Package Leaflet",
            "code" : {
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              "text" : "B. PACKAGE LEAFLET"
            },
            "text" : {
              "status" : "additional",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
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            "section" : [
              {
                "title" : "Package leaflet: Information for the user",
                "code" : {
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                  "text" : "Package leaflet: Information for the user"
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                "text" : {
                  "status" : "additional",
                  "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>"
                }
              },
              {
                "title" : "What is in this leaflet",
                "code" : {
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                "text" : {
                  "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" : {
                  "coding" : [
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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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                      "system" : "https://spor.ema.europa.eu/rmswi/",
                      "code" : "100000155538"
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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" : {
                  "coding" : [
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                      "system" : "https://spor.ema.europa.eu/rmswi/",
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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" : [
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                      "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",
                "code" : {
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                      "system" : "https://spor.ema.europa.eu/rmswi/",
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                  "text" : "6. Contents of the pack and other information"
                },
                "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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      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-dolutegravirsodium",
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        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-dovato-microcrystallinecellulose\"> </a><p><b>Generated Narrative: Ingredient</b><a name=\"ingredient-for-dovato-microcrystallinecellulose\"> </a><a name=\"hcingredient-for-dovato-microcrystallinecellulose\"> </a></p><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\">ResourceIngredient &quot;ingredient-for-dovato-microcrystallinecellulose&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/OP1R32D61U\u00a0(use:\u00a0official)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li>See on this page: ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f</li><li>See on this page: MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e</li><li>See on this page: AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f</li></ul><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000072082)</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>microcrystalline cellulose <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (beta#OP1R32D61U)</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><b>Generated Narrative: Ingredient</b><a name=\"ingredient-for-dovato-sodiumstarchglycolate\"> </a><a name=\"hcingredient-for-dovato-sodiumstarchglycolate\"> </a></p><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\">ResourceIngredient &quot;ingredient-for-dovato-sodiumstarchglycolate&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/H8AV0SQX4D\u00a0(use:\u00a0official)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li>See on this page: ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f</li><li>See on this page: MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e</li><li>See on this page: AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f</li></ul><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000072082)</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>sodium starch glycolate <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (beta#H8AV0SQX4D)</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><b>Generated Narrative: Ingredient</b><a name=\"ingredient-for-dovato-magnesiumstearate\"> </a><a name=\"hcingredient-for-dovato-magnesiumstearate\"> </a></p><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\">ResourceIngredient &quot;ingredient-for-dovato-magnesiumstearate&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/70097M6I30\u00a0(use:\u00a0official)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li>See on this page: ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f</li><li>See on this page: MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e</li><li>See on this page: AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f</li></ul><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000072082)</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>magnesium stearate <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (beta#70097M6I30)</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><b>Generated Narrative: Ingredient</b><a name=\"ingredient-for-dovato-mannitol\"> </a><a name=\"hcingredient-for-dovato-mannitol\"> </a></p><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\">ResourceIngredient &quot;ingredient-for-dovato-mannitol&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/3OWL53L36A\u00a0(use:\u00a0official)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li>See on this page: ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f</li><li>See on this page: MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e</li><li>See on this page: AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f</li></ul><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000072082)</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>mannitol <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (beta#3OWL53L36A)</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><b>Generated Narrative: SubstanceDefinition</b><a name=\"substance-dolutegravirsodium\"> </a><a name=\"hcsubstance-dolutegravirsodium\"> </a></p><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\">ResourceSubstanceDefinition &quot;substance-dolutegravirsodium&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-SubstanceDefinition-uv-epi.html\">SubstanceDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/1Q1V9V5WYQ\u00a0(use:\u00a0official)</p><p><b>version</b>: 1</p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>manufacturer</b>: See on this page: Organization/man-173fde4cb6b1018cb7ec8ab708d3961c</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>exact <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</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>Chemical Name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#x)</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><b>Generated Narrative: SubstanceDefinition</b><a name=\"substance-lamivudine\"> </a><a name=\"hcsubstance-lamivudine\"> </a></p><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\">ResourceSubstanceDefinition &quot;substance-lamivudine&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-SubstanceDefinition-uv-epi.html\">SubstanceDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/2T8Q726O95\u00a0(use:\u00a0official)</p><p><b>version</b>: 1</p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>manufacturer</b>: See on this page: Organization/man-173fde4cb6b1018cb7ec8ab708d3961c</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>exact <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</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>Chemical Name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#x)</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",
                  "display" : "Chemical Name"
                }
              ]
            }
          }
        ]
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f",
      "resource" : {
        "resourceType" : "AdministrableProductDefinition",
        "id" : "ap-49178f16170ee8a6bc2a4361c1748d5f",
        "meta" : {
          "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><b>Generated Narrative: AdministrableProductDefinition</b><a name=\"ap-49178f16170ee8a6bc2a4361c1748d5f\"> </a><a name=\"hcap-49178f16170ee8a6bc2a4361c1748d5f\"> </a></p><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\">ResourceAdministrableProductDefinition &quot;ap-49178f16170ee8a6bc2a4361c1748d5f&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-AdministrableProductDefinition-uv-epi.html\">AdministrableProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/123456</p><p><b>status</b>: active</p><p><b>formOf</b>: See on this page: MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e</p><p><b>administrableDoseForm</b>: Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000073664)</span></p><p><b>unitOfPresentation</b>: Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#200000002152)</span></p><p><b>producedFrom</b>: See on this page: ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f</p><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: Oral use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000073619)</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>Human <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000109093)</span></td></tr></table></blockquote></div>"
        },
        "identifier" : [
          {
            "system" : "https://spor.ema.europa.eu/pmswi",
            "value" : "123456"
          }
        ],
        "status" : "active",
        "formOf" : [
          {
            "reference" : "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e"
          }
        ],
        "administrableDoseForm" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000073664",
              "display" : "Tablet"
            }
          ]
        },
        "unitOfPresentation" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "200000002152",
              "display" : "Tablet"
            }
          ]
        },
        "producedFrom" : [
          {
            "reference" : "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f"
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        ],
        "routeOfAdministration" : [
          {
            "code" : {
              "coding" : [
                {
                  "system" : "https://spor.ema.europa.eu/rmswi",
                  "code" : "100000073619",
                  "display" : "Oral use"
                }
              ]
            },
            "targetSpecies" : [
              {
                "code" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/rmswi",
                      "code" : "100000109093",
                      "display" : "Human"
                    }
                  ]
                }
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization49178f16170ee8a6bc2a4361c1748d5f0",
      "resource" : {
        "resourceType" : "RegulatedAuthorization",
        "id" : "authorization49178f16170ee8a6bc2a4361c1748d5f0",
        "meta" : {
          "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><b>Generated Narrative: RegulatedAuthorization</b><a name=\"authorization49178f16170ee8a6bc2a4361c1748d5f0\"> </a><a name=\"hcauthorization49178f16170ee8a6bc2a4361c1748d5f0\"> </a></p><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\">ResourceRegulatedAuthorization &quot;authorization49178f16170ee8a6bc2a4361c1748d5f0&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-RegulatedAuthorization-uv-epi.html\">RegulatedAuthorization (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/19/1370/001\u00a0(use:\u00a0official)</p><p><b>subject</b>: See on this page: MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e</p><p><b>type</b>: Marketing Authorisation <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#220000000061)</span></p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2019-07-01 13:28:17+0000</p><p><b>holder</b>: See on this page: Organization/mah-31ff1af739c7dcf77386a86f8dd83d29</p><p><b>regulator</b>: See on this page: Organization/mra-7c9b97127f73ff3605a10eb1c2cc24d1</p></div>"
        },
        "identifier" : [
          {
            "use" : "official",
            "system" : "https://spor.ema.europa.eu/pmswi",
            "value" : "EU/1/19/1370/001"
          }
        ],
        "subject" : [
          {
            "reference" : "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e"
          }
        ],
        "type" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "220000000061",
              "display" : "Marketing Authorisation"
            }
          ]
        },
        "status" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/publication-status",
              "code" : "active",
              "display" : "Active"
            }
          ]
        },
        "statusDate" : "2019-07-01T13:28:17Z",
        "holder" : {
          "reference" : "Organization/mah-31ff1af739c7dcf77386a86f8dd83d29"
        },
        "regulator" : {
          "reference" : "Organization/mra-7c9b97127f73ff3605a10eb1c2cc24d1"
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Organization/man-173fde4cb6b1018cb7ec8ab708d3961c",
      "resource" : {
        "resourceType" : "Organization",
        "id" : "man-173fde4cb6b1018cb7ec8ab708d3961c",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_man-173fde4cb6b1018cb7ec8ab708d3961c\"> </a><p><b>Generated Narrative: Organization</b><a name=\"man-173fde4cb6b1018cb7ec8ab708d3961c\"> </a><a name=\"hcman-173fde4cb6b1018cb7ec8ab708d3961c\"> </a></p><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\">ResourceOrganization &quot;man-173fde4cb6b1018cb7ec8ab708d3961c&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Organization-uv-epi.html\">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/ORG-100004538\u00a0(use:\u00a0official)</p><p><b>active</b>: true</p><p><b>type</b>: Manufacturer <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#220000000033)</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>"
        },
        "identifier" : [
          {
            "use" : "official",
            "system" : "https://spor.ema.europa.eu/omswi",
            "value" : "ORG-100004538"
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        ],
        "active" : true,
        "type" : [
          {
            "coding" : [
              {
                "system" : "https://spor.ema.europa.eu/rmswi",
                "code" : "220000000033",
                "display" : "Manufacturer"
              }
            ]
          }
        ],
        "name" : "GLAXO WELLCOME, S.A.",
        "contact" : [
          {
            "address" : {
              "use" : "work",
              "type" : "physical",
              "text" : "Avda. Extremadura 3, 09400 Aranda De Duero Aranda De Duero ES",
              "line" : [
                "Avda. Extremadura 3, 09400 Aranda De Duero"
              ],
              "city" : "Aranda De Duero",
              "country" : "ES"
            }
          }
        ]
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-31ff1af739c7dcf77386a86f8dd83d29",
      "resource" : {
        "resourceType" : "Organization",
        "id" : "mah-31ff1af739c7dcf77386a86f8dd83d29",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_mah-31ff1af739c7dcf77386a86f8dd83d29\"> </a><p><b>Generated Narrative: Organization</b><a name=\"mah-31ff1af739c7dcf77386a86f8dd83d29\"> </a><a name=\"hcmah-31ff1af739c7dcf77386a86f8dd83d29\"> </a></p><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\">ResourceOrganization &quot;mah-31ff1af739c7dcf77386a86f8dd83d29&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Organization-uv-epi.html\">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/ORG-100012958\u00a0(use:\u00a0official)</p><p><b>active</b>: true</p><p><b>type</b>: Marketing authorisation holder <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#220000000034)</span></p><p><b>name</b>: ViiV Healthcare BV</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Van Asch van Wijckstraat 55H Amersfoort NL(work)</td></tr></table></div>"
        },
        "identifier" : [
          {
            "use" : "official",
            "system" : "https://spor.ema.europa.eu/omswi",
            "value" : "ORG-100012958"
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        ],
        "active" : true,
        "type" : [
          {
            "coding" : [
              {
                "system" : "https://spor.ema.europa.eu/rmswi",
                "code" : "220000000034",
                "display" : "Marketing authorisation holder"
              }
            ]
          }
        ],
        "name" : "ViiV Healthcare BV",
        "contact" : [
          {
            "address" : {
              "use" : "work",
              "type" : "physical",
              "text" : "Van Asch van Wijckstraat 55H Amersfoort NL",
              "line" : [
                "Van Asch van Wijckstraat 55H"
              ],
              "city" : "Amersfoort",
              "country" : "NL"
            }
          }
        ]
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Organization/mra-7c9b97127f73ff3605a10eb1c2cc24d1",
      "resource" : {
        "resourceType" : "Organization",
        "id" : "mra-7c9b97127f73ff3605a10eb1c2cc24d1",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_mra-7c9b97127f73ff3605a10eb1c2cc24d1\"> </a><p><b>Generated Narrative: Organization</b><a name=\"mra-7c9b97127f73ff3605a10eb1c2cc24d1\"> </a><a name=\"hcmra-7c9b97127f73ff3605a10eb1c2cc24d1\"> </a></p><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\">ResourceOrganization &quot;mra-7c9b97127f73ff3605a10eb1c2cc24d1&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Organization-uv-epi.html\">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/ORG-100013412\u00a0(use:\u00a0official)</p><p><b>active</b>: true</p><p><b>type</b>: Medicines Regulatory Authority <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#220000000032)</span></p><p><b>name</b>: European Medicines Agency</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Carretera De Martorell 41 61, Poligono Industrial Nord-Est Amsterdam NL(work)</td></tr></table></div>"
        },
        "identifier" : [
          {
            "use" : "official",
            "system" : "https://spor.ema.europa.eu/omswi",
            "value" : "ORG-100013412"
          }
        ],
        "active" : true,
        "type" : [
          {
            "coding" : [
              {
                "system" : "https://spor.ema.europa.eu/rmswi",
                "code" : "220000000032",
                "display" : "Medicines Regulatory Authority"
              }
            ]
          }
        ],
        "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><b>Generated Narrative: PackagedProductDefinition</b><a name=\"ppd-2977a2afce16a0bd914b8d242dd126b5\"> </a><a name=\"hcppd-2977a2afce16a0bd914b8d242dd126b5\"> </a></p><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\">ResourcePackagedProductDefinition &quot;ppd-2977a2afce16a0bd914b8d242dd126b5&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-PackagedProductDefinition-uv-epi.html\">PackagedProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/19/1370/001\u00a0(use:\u00a0official)</p><p><b>name</b>: Dovato 50 mg/300 mg film-coated tablets 30</p><p><b>type</b>: Chemical Medicinal Product <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000155527)</span></p><p><b>packageFor</b>: See on this page: MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e</p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2012-02-07 13:28:17+0000</p><p><b>manufacturer</b>: See on this page: Organization/man-173fde4cb6b1018cb7ec8ab708d3961c</p><blockquote><p><b>packaging</b></p><p><b>type</b>: Box <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000073498)</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: Cardboard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#200000003529)</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>: Child-resistant closure <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000073504)</span></p><p><b>quantity</b>: 30</p><p><b>material</b>: Glass <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#200000003203)</span></p><blockquote><p><b>containedItem</b></p></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><b>Generated Narrative: MedicinalProductDefinition</b><a name=\"mp16598f252d07b4784b82ba43cf9e847e\"> </a><a name=\"hcmp16598f252d07b4784b82ba43cf9e847e\"> </a></p><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\">ResourceMedicinalProductDefinition &quot;mp16598f252d07b4784b82ba43cf9e847e&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-MedicinalProductDefinition-uv-epi.html\">MedicinalProductDefinition (ePI)</a></p></div><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>: Medicinal Product <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-type.html\">Medicinal Product Type</a>#MedicinalProduct)</span></p><p><b>domain</b>: Human use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-domain.html\">Medicinal Product Domain</a>#Human)</span></p><p><b>status</b>: active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>legalStatusOfSupply</b>: Medicinal product subject to medical prescription <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000072084)</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>: Full name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (220000000000#220000000001)</span></p><blockquote><p><b>part</b></p><p><b>part</b>: Dovato</p><p><b>type</b>: Invented name part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (220000000000#220000000002)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: dolutegravir/lamivudine</p><p><b>type</b>: Scientific name part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (220000000000#220000000003)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 50 mg/300 mg</p><p><b>type</b>: Strength part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (220000000000#220000000004)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: film-coated tablets</p><p><b>type</b>: Pharmaceutical dose form part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (220000000000#220000000005)</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>United Kingdom <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#GBR)</span></td><td>United Kingdom <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#GBR)</span></td><td>English <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-ietf3066.html\">Tags for the Identification of Languages</a>#en)</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"
                    }
                  ]
                }
              },
              {
                "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"
                    }
                  ]
                },
                "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><b>Generated Narrative: ManufacturedItemDefinition</b><a name=\"mid-49178f16170ee8a6bc2a4361c1748d5f\"> </a><a name=\"hcmid-49178f16170ee8a6bc2a4361c1748d5f\"> </a></p><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\">ResourceManufacturedItemDefinition &quot;mid-49178f16170ee8a6bc2a4361c1748d5f&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-ManufacturedItemDefinition-uv-epi.html\">ManufacturedItemDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/19/1370/001\u00a0(use:\u00a0official)</p><p><b>status</b>: active</p><p><b>manufacturedDoseForm</b>: Film-coated tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000073665)</span></p><p><b>unitOfPresentation</b>: Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#200000002152)</span></p><p><b>manufacturer</b>: See on this page: Organization/man-173fde4cb6b1018cb7ec8ab708d3961c</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"
          }
        ]
      }
    }
  ]
}