Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/gravitate-health/ and changes regularly. See the Directory of published versions
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Prospecto: información para el paciente Dovato 50 mg/300 mg comprimidos recubiertos con película dolutegravir/lamivudina <b>Lea todo el prospecto detenidamente antes de empezar a tomar este medicamento, porque contiene información importante para usted.</b><ul><li>Conserve este prospecto, ya que puede tener que volver a leerlo.</li><li>Si tiene alguna duda, consulte a su médico o farmacéutico.</li><li>Este medicamento se le ha recetado solamente a usted, y no debe dárselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles.</li><li>Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.</li></ul></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Contenido del prospecto<ol><li>Qué es Dovato y para qué se utiliza</li><li>Qué necesita saber antes de empezar a tomar Dovato</li><li>Cómo tomar Dovato</li><li>Posibles efectos adversos</li><li>Conservación de Dovato</li><li>Contenido del envase e información adicional</li></ol></div>"
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"title" : "1. Qué es Dovato y para qué se utiliza",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><strong>No tome Dovato</strong></p><ul><li>si es alérgico (hipersensible) a dolutegravir o lamivudina o a alguno de los demás componentes de este medicamento (incluidos en la sección 6)</li><li>si está tomando un medicamento llamado fampridina (también conocido como dalfampridina; utilizado para tratar la esclerosis múltiple).</li></ul><p>? Si cree que algo de esto le aplica, consulte a su médico.</p><p><strong>Advertencias y precauciones</strong> Algunas personas que toman Dovato u otros tratamientos combinados frente al VIH tienen un mayor riesgo de desarrollar efectos adversos graves que otras. Usted necesita saber que hay un mayor riesgo:</p><ul><li>si tiene una enfermedad hepática moderada o grave</li><li>si alguna vez ha tenido una enfermedad hepática, incluyendo hepatitis B o C (si tiene hepatitis B no deje de tomar Dovato sin el consejo de su médico, ya que podría empeorar)</li><li>si tiene un problema de riñón.</li></ul><p>? Consulte a su médico antes de empezar a tomar Dovato si le aplica alguna de estas condiciones. Puede necesitar pruebas adicionales, incluyendo análisis de sangre, mientras toma este medicamento. Para más información, ver sección 4.</p><p><em>Reacciones alérgicas</em></p><p>Dovato contiene dolutegravir. Dolutegravir puede producir una reacción alérgica grave conocida como reacción de hipersensibilidad. Usted necesita saber a qué signos y síntomas importantes debe estar atento mientras esté tomando Dovato.</p><p>? Lea la información “Reacciones alérgicas” en la sección 4 de este prospecto.</p><p><em>Esté atento a los síntomas importantes</em></p><p>Algunas personas que toman medicamentos para la infección por el VIH desarrollan otros trastornos, que pueden ser graves. Estos incluyen:</p><ul><li>síntomas de infecciones e inflamación</li><li>dolor en las articulaciones, rigidez y problemas de huesos.</li></ul><p>Usted necesita saber a qué signos y síntomas importantes debe estar atento mientras esté tomando Dovato.</p><p>? Lea la información sobre “Otros posibles efectos adversos” en la sección 4 de este prospecto.</p><p><strong>Niños</strong></p><p>Este medicamento no está indicado en niños menores de 12 años, porque no ha sido estudiado en estos pacientes.</p><p><strong>Otros medicamentos y Dovato</strong> Informe a su médico si está tomando, ha tomado recientemente o pudiera tener que tomar cualquier otro medicamento.</p><p>No tome Dovato con el siguiente medicamento:</p><ul><li>fampridina (también conocido como dalfampridina), utilizado para tratar la esclerosis múltiple.</li></ul><p>Algunos medicamentos pueden afectar al funcionamiento de Dovato o aumentar la probabilidad de sufrir efectos adversos. Dovato también puede afectar al funcionamiento de algunos otros medicamentos.</p><p>Informe a su médico si está tomando alguno de los siguientes medicamentos:</p><ul><li>metformina, para tratar la diabetes</li><li>medicamentos llamados antiácidos, para tratar la indigestión y el ardor de estómago. No tome un antiácido durante las 6 horas antes de tomar Dovato, o por lo menos 2 horas después de tomarlo (ver también sección 3, “Cómo tomar Dovato”).</li><li>suplementos o multivitamínicos que contienen calcio, hierro o magnesio. Si toma Dovato con comida, puede tomar los suplementos o multivitamínicos que contengan calcio, hierro o magnesio a la vez que Dovato. Si no toma Dovato con comida, no puede tomar un suplemento o multivitamínico que contenga calcio, hierro o magnesio durante las 6 horas antes de tomar Dovato, o por lo menos 2 horas después de tomarlo (ver también sección 3, “Cómo tomar Dovato”).</li><li>emtricitabina, etravirina, efavirenz, nevirapina o tipranavir/ritonavir, para tratar la infección por el VIH medicamentos (generalmente líquidos) que contengan sorbitol y otros polialcoholes (como xilitol, manitol, lactitol o maltitol), si se toman con regularidad</li><li>cladribina, utilizada para tratar la leucemia o la esclerosis múltiple</li><li>rifampicina, para tratar la tuberculosis (TB) y otras infecciones bacterianas</li><li>fenitoína y fenobarbital, para tratar la epilepsia</li><li>oxcarbazepina y carbamazepina, para tratar la epilepsia o el trastorno bipolar</li><li>hierba de San Juan (Hypericum perforatum), un medicamento a base de plantas para tratar la depresión.</li></ul><p>? Informe a su médico o farmacéutico si está tomando alguno de estos medicamentos. Su médico puede decidir ajustar su dosis o que usted necesite chequeos adicionales.</p><p><strong>Embarazo</strong></p><p>Si está embarazada, cree que podría estar embarazada o tiene intención de quedarse embarazada:</p><p>? Consulte a su médico sobre los riegos y beneficios de tomar Dovato.</p><p>Tomar Dovato en el momento de quedarse embarazada o durante las primeras seis semanas de embarazo puede aumentar el riesgo de un defecto de nacimiento, denominado defecto del tubo neural, como la espina bífida (malformación de la médula espinal).</p><p>Si existe la posibilidad de quedarse embarazada mientras está tomando Dovato:</p><p>? Consulte a su médico y valore si existe la necesidad de utilizar un método anticonceptivo, como preservativos o anticonceptivos orales.</p><p>Informe a su médico de inmediato si se queda embarazada o tiene intención de quedarse embarazada. Su médico revisará su tratamiento. No interrumpa el tratamiento con Dovato sin consultar a su médico, ya que esto podría dañarles a usted y a su hijo.</p><p><strong>Lactancia</strong></p><p><strong>No se recomienda</strong> que las mujeres que conviven con el VIH den el pecho porque la infección por VIH puede transmitirse al bebé a través de la leche materna.</p><p>Una pequeña cantidad de los componentes de Dovato también pueden pasar a la leche materna.</p><p>Si está dando el pecho o piensa en dar el pecho, debe consultar con su médico lo antes posible.</p><p><strong>Conducción y uso de máquinas</strong> Dovato puede hacer que se sienta mareado y puede tener otros efectos adversos que reduzcan su atención.</p>? No conduzca ni maneje maquinaria, a menos que esté seguro que no está afectado.</div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>3. Cómo tomar Dovato</b><p>Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico. En caso de duda, consulte de nuevo a su médico o farmacéutico.</p><ul><li>La dosis recomendada de Dovato es <b>un comprimido una vez al día.</b></li></ul><p>Trague el comprimido con un poco de líquido. Dovato se puede tomar con o sin alimentos.</p></div>"
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"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>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>5. Conservación de Dovato</b><p>Mantener este medicamento fuera de la vista y del alcance de los niños</p><p>No utilice este medicamento después de la fecha de caducidad que aparece en la caja y el frasco después de CAD. La fecha de caducidad es el último día del mes que se indica.</p><p>Este medicamento no requiere ninguna condición especial de conservación.</p><p>Los medicamentos no se deben tirar por los desagües ni a la basura. Pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que ya no necesita. De esta forma, ayudará a proteger el medio ambiente.</p></div>"
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"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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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-dovato-lamivudine\"> </a><p><b>Generated Narrative: Ingredient</b><a name=\"ingredient-for-dovato-lamivudine\"> </a><a name=\"hcingredient-for-dovato-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\">ResourceIngredient "ingredient-for-dovato-lamivudine" </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>/2T8Q726O95\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>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#100000072072)</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>lamivudine <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (beta#2T8Q726O95)</span></td></tr></table><h3>Strengths</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style=\"display: none\">*</td><td>300 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code mg = 'mg')</span></td><td>active ingredient - basis of strength <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-RoleClass.html\">RoleClass</a>#ACTIB)</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"use" : "official",
"system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
"value" : "2T8Q726O95"
},
"status" : "active",
"for" : [
{
"reference" : "ManufacturedItemDefinition/mid-49178f16170ee8a6bc2a4361c1748d5f"
},
{
"reference" : "MedicinalProductDefinition/mp16598f252d07b4784b82ba43cf9e847e"
},
{
"reference" : "AdministrableProductDefinition/ap-49178f16170ee8a6bc2a4361c1748d5f"
}
],
"role" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000072072",
"display" : "Active"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
"code" : "2T8Q726O95",
"display" : "lamivudine"
}
]
}
},
"strength" : [
{
"presentationQuantity" : {
"value" : 300,
"system" : "http://unitsofmeasure.org",
"code" : "mg"
},
"basis" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
"code" : "ACTIB",
"display" : "active ingredient - basis of strength"
}
]
}
}
]
}
}
},
{
"fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-dovato-microcrystallinecellulose",
"resource" : {
"resourceType" : "Ingredient",
"id" : "ingredient-for-dovato-microcrystallinecellulose",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-dovato-microcrystallinecellulose\"> </a><p><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 "ingredient-for-dovato-microcrystallinecellulose" </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 "ingredient-for-dovato-sodiumstarchglycolate" </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 "ingredient-for-dovato-magnesiumstearate" </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 "ingredient-for-dovato-mannitol" </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 "substance-dolutegravirsodium" </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 "substance-lamivudine" </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"
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],
"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 "ap-49178f16170ee8a6bc2a4361c1748d5f" </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"
}
],
"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 "authorization49178f16170ee8a6bc2a4361c1748d5f0" </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 "man-173fde4cb6b1018cb7ec8ab708d3961c" </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"
}
],
"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 "mah-31ff1af739c7dcf77386a86f8dd83d29" </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"
}
],
"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 "mra-7c9b97127f73ff3605a10eb1c2cc24d1" </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 "ppd-2977a2afce16a0bd914b8d242dd126b5" </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 "mp16598f252d07b4784b82ba43cf9e847e" </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 "mid-49178f16170ee8a6bc2a4361c1748d5f" </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"
}
]
}
}
]
}
IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.gh#0.1.0 based on FHIR 5.0.0. Generated 2024-05-15
Links: Table of Contents |
QA Report
The Gravitate Health project has received funding from the IMI 2 Joint Undertaking under grant agreement No 945334.
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.
