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
{
"resourceType" : "Bundle",
"id" : "bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"
]
},
"language" : "en",
"identifier" : {
"system" : "https://www.gravitatehealth.eu/sid/doc",
"value" : "7027e635478c3b3a26b4c7ea7238a57c"
},
"type" : "document",
"timestamp" : "2023-06-27T10:09:22Z",
"entry" : [
{
"fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Composition/composition-en-aae8d931abe2f2d9085b87555b9bb088",
"resource" : {
"resourceType" : "Composition",
"id" : "composition-en-aae8d931abe2f2d9085b87555b9bb088",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><a name=\"Composition_composition-en-aae8d931abe2f2d9085b87555b9bb088\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-aae8d931abe2f2d9085b87555b9bb088</b></p><a name=\"composition-en-aae8d931abe2f2d9085b87555b9bb088\"> </a><a name=\"hccomposition-en-aae8d931abe2f2d9085b87555b9bb088\"> </a><a name=\"composition-en-aae8d931abe2f2d9085b87555b9bb088-en-US\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Language: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>nan</code>/eb2d55ad5005be64271cb8d7a8411595</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi/ 100000155538}\">Package Leaflet</span></p><p><b>category</b>: <span title=\"Codes:{http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs R}\">Raw</span></p><p><b>date</b>: 2022-02-16 13:28:17+0000</p><p><b>author</b>: <a href=\"Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#Organization_mah-5192019d531d0f82a0e8d8ffcb39b68a\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>title</b>: TEST PURPOSES ONLY - Ogivri 150 mg powder for concentrate for solution for infusion </p><h3>Attesters</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/composition-attestation-mode official}\">Official</span></td><td>2022-02-16 13:28:17+0000</td></tr></table></div>"
},
"identifier" : [
{
"system" : "nan",
"value" : "eb2d55ad5005be64271cb8d7a8411595"
}
],
"status" : "final",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "100000155538"
}
],
"text" : "Package Leaflet"
},
"category" : [
{
"coding" : [
{
"system" : "http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs",
"code" : "R",
"display" : "Raw"
}
]
}
],
"subject" : [
{
"reference" : "MedicinalProductDefinition/mpaae8d931abe2f2d9085b87555b9bb088"
}
],
"date" : "2022-02-16T13:28:17Z",
"author" : [
{
"reference" : "Organization/mah-5192019d531d0f82a0e8d8ffcb39b68a"
}
],
"title" : "TEST PURPOSES ONLY - Ogivri 150 mg powder for concentrate for solution for infusion ",
"attester" : [
{
"mode" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/composition-attestation-mode",
"code" : "official"
}
]
},
"time" : "2022-02-16T13:28:17Z"
}
],
"section" : [
{
"title" : "B. Package Leaflet",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "100000155538"
}
],
"text" : "B. Package Leaflet"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
},
"section" : [
{
"title" : "Package leaflet: Information for the user",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "100000155538"
}
],
"text" : "Package leaflet: Information for the user"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
}
},
{
"title" : "What is in this leaflet",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "100000155538"
}
],
"text" : "What is in this leaflet"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
}
},
{
"title" : "1. What 0 is and what it is used for",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "100000155538"
}
],
"text" : "1. What 0 is and what it is used for"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
}
},
{
"title" : "2. What you need to know before you take 0",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "100000155538"
}
],
"text" : "2. What you need to know before you take 0"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
}
},
{
"title" : "3. How to take 0",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "100000155538"
}
],
"text" : "3. How to take 0"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
}
},
{
"title" : "4. Possible side effects",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "100000155538"
}
],
"text" : "4. Possible side effects"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
}
},
{
"title" : "5. How to store 0",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "100000155538"
}
],
"text" : "5. How to store 0"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
}
},
{
"title" : "6. Contents of the pack and other information",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "100000155538"
}
],
"text" : "6. Contents of the pack and other information"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
},
"emptyReason" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
"code" : "unavailable"
}
]
}
}
]
}
]
}
},
{
"fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-trastuzumab-sorbitol",
"resource" : {
"resourceType" : "Ingredient",
"id" : "ingredient-for-trastuzumab-sorbitol",
"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-trastuzumab-sorbitol\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-for-trastuzumab-sorbitol</b></p><a name=\"ingredient-for-trastuzumab-sorbitol\"> </a><a name=\"hcingredient-for-trastuzumab-sorbitol\"> </a><a name=\"ingredient-for-trastuzumab-sorbitol-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/506T60A25R\u00a0(use:\u00a0official,\u00a0)</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#ManufacturedItemDefinition_mid-5af3df1132d20d744a88dab06e924e5e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#MedicinalProductDefinition_mpaae8d931abe2f2d9085b87555b9bb088\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#AdministrableProductDefinition_ap-5af3df1132d20d744a88dab06e924e5e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072082}\">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 506T60A25R}\">SORBITOL</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"use" : "official",
"system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
"value" : "506T60A25R"
},
"status" : "active",
"for" : [
{
"reference" : "ManufacturedItemDefinition/mid-5af3df1132d20d744a88dab06e924e5e"
},
{
"reference" : "MedicinalProductDefinition/mpaae8d931abe2f2d9085b87555b9bb088"
},
{
"reference" : "AdministrableProductDefinition/ap-5af3df1132d20d744a88dab06e924e5e"
}
],
"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" : "506T60A25R",
"display" : "SORBITOL"
}
]
}
}
}
}
},
{
"fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-trastuzumab-trastuzumab",
"resource" : {
"resourceType" : "Ingredient",
"id" : "ingredient-for-trastuzumab-trastuzumab",
"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-trastuzumab-trastuzumab\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-for-trastuzumab-trastuzumab</b></p><a name=\"ingredient-for-trastuzumab-trastuzumab\"> </a><a name=\"hcingredient-for-trastuzumab-trastuzumab\"> </a><a name=\"ingredient-for-trastuzumab-trastuzumab-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/P188ANX8CK\u00a0(use:\u00a0official,\u00a0)</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#ManufacturedItemDefinition_mid-5af3df1132d20d744a88dab06e924e5e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#MedicinalProductDefinition_mpaae8d931abe2f2d9085b87555b9bb088\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#AdministrableProductDefinition_ap-5af3df1132d20d744a88dab06e924e5e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072072}\">Active</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta P188ANX8CK}\">trastuzumab</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>150 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span></td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}\">active ingredient - basis of strength</span></td></tr></table></blockquote></div>"
},
"identifier" : {
"use" : "official",
"system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
"value" : "P188ANX8CK"
},
"status" : "active",
"for" : [
{
"reference" : "ManufacturedItemDefinition/mid-5af3df1132d20d744a88dab06e924e5e"
},
{
"reference" : "MedicinalProductDefinition/mpaae8d931abe2f2d9085b87555b9bb088"
},
{
"reference" : "AdministrableProductDefinition/ap-5af3df1132d20d744a88dab06e924e5e"
}
],
"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" : "P188ANX8CK",
"display" : "trastuzumab"
}
]
}
},
"strength" : [
{
"presentationQuantity" : {
"value" : 150,
"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/SubstanceDefinition/substance-trastuzumab",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "substance-trastuzumab",
"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-trastuzumab\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition substance-trastuzumab</b></p><a name=\"substance-trastuzumab\"> </a><a name=\"hcsubstance-trastuzumab\"> </a><a name=\"substance-trastuzumab-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/P188ANX8CK\u00a0(use:\u00a0official,\u00a0)</p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>manufacturer</b>: <a href=\"Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#Organization_mah-5192019d531d0f82a0e8d8ffcb39b68a\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>"
},
"identifier" : [
{
"use" : "official",
"system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
"value" : "P188ANX8CK"
}
],
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active"
}
]
},
"manufacturer" : [
{
"reference" : "Organization/mah-5192019d531d0f82a0e8d8ffcb39b68a"
}
]
}
},
{
"fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-5af3df1132d20d744a88dab06e924e5e",
"resource" : {
"resourceType" : "AdministrableProductDefinition",
"id" : "ap-5af3df1132d20d744a88dab06e924e5e",
"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-5af3df1132d20d744a88dab06e924e5e\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition ap-5af3df1132d20d744a88dab06e924e5e</b></p><a name=\"ap-5af3df1132d20d744a88dab06e924e5e\"> </a><a name=\"hcap-5af3df1132d20d744a88dab06e924e5e\"> </a><a name=\"ap-5af3df1132d20d744a88dab06e924e5e-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/id</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#MedicinalProductDefinition_mpaae8d931abe2f2d9085b87555b9bb088\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>administrableDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073863}\">Solution for injection</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000002158}\">Vial</span></p><p><b>producedFrom</b>: <a href=\"Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#ManufacturedItemDefinition_mid-5af3df1132d20d744a88dab06e924e5e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073611}\">Intravenous use</span></p><h3>TargetSpecies</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000109093}\">Human</span></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "https://spor.ema.europa.eu/pmswi",
"value" : "id"
}
],
"status" : "active",
"formOf" : [
{
"reference" : "MedicinalProductDefinition/mpaae8d931abe2f2d9085b87555b9bb088"
}
],
"administrableDoseForm" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000073863",
"display" : "Solution for injection"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000002158",
"display" : "Vial"
}
]
},
"producedFrom" : [
{
"reference" : "ManufacturedItemDefinition/mid-5af3df1132d20d744a88dab06e924e5e"
}
],
"routeOfAdministration" : [
{
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000073611",
"display" : "Intravenous use"
}
]
},
"targetSpecies" : [
{
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000109093",
"display" : "Human"
}
]
}
}
]
}
]
}
},
{
"fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization5af3df1132d20d744a88dab06e924e5e0",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "authorization5af3df1132d20d744a88dab06e924e5e0",
"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_authorization5af3df1132d20d744a88dab06e924e5e0\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization authorization5af3df1132d20d744a88dab06e924e5e0</b></p><a name=\"authorization5af3df1132d20d744a88dab06e924e5e0\"> </a><a name=\"hcauthorization5af3df1132d20d744a88dab06e924e5e0\"> </a><a name=\"authorization5af3df1132d20d744a88dab06e924e5e0-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/18/1341/001\u00a0(use:\u00a0official,\u00a0)</p><p><b>subject</b>: <a href=\"Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#MedicinalProductDefinition_mpaae8d931abe2f2d9085b87555b9bb088\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 220000000061}\">Marketing Authorisation</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>statusDate</b>: 2018-12-12 00:00:00+0000</p><p><b>holder</b>: <a href=\"Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#Organization_mah-5192019d531d0f82a0e8d8ffcb39b68a\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>"
},
"identifier" : [
{
"use" : "official",
"system" : "https://spor.ema.europa.eu/pmswi",
"value" : "EU/1/18/1341/001"
}
],
"subject" : [
{
"reference" : "MedicinalProductDefinition/mpaae8d931abe2f2d9085b87555b9bb088"
}
],
"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" : "2018-12-12T00:00:00Z",
"holder" : {
"reference" : "Organization/mah-5192019d531d0f82a0e8d8ffcb39b68a"
}
}
},
{
"fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-5192019d531d0f82a0e8d8ffcb39b68a",
"resource" : {
"resourceType" : "Organization",
"id" : "mah-5192019d531d0f82a0e8d8ffcb39b68a",
"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-5192019d531d0f82a0e8d8ffcb39b68a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization mah-5192019d531d0f82a0e8d8ffcb39b68a</b></p><a name=\"mah-5192019d531d0f82a0e8d8ffcb39b68a\"> </a><a name=\"hcmah-5192019d531d0f82a0e8d8ffcb39b68a\"> </a><a name=\"mah-5192019d531d0f82a0e8d8ffcb39b68a-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/ORG-100034260\u00a0(use:\u00a0official,\u00a0)</p><p><b>active</b>: true</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 220000000034}\">Marketing authorisation holder</span></p><p><b>name</b>: Viatris Limited</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>Damastown Industrial Park, Mulhuddart, Dublin 15 Dublin IR(work)</td></tr></table></div>"
},
"identifier" : [
{
"use" : "official",
"system" : "https://spor.ema.europa.eu/omswi",
"value" : "ORG-100034260"
}
],
"active" : true,
"type" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "220000000034",
"display" : "Marketing authorisation holder"
}
]
}
],
"name" : "Viatris Limited",
"contact" : [
{
"address" : {
"use" : "work",
"type" : "physical",
"text" : "Damastown Industrial Park, Mulhuddart, Dublin 15 Dublin IR",
"line" : [
"Damastown Industrial Park, Mulhuddart, Dublin 15"
],
"city" : "Dublin",
"country" : "IR"
}
}
]
}
},
{
"fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-e7c391536e9fc6ff50198d09558da8c0",
"resource" : {
"resourceType" : "PackagedProductDefinition",
"id" : "ppd-e7c391536e9fc6ff50198d09558da8c0",
"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-e7c391536e9fc6ff50198d09558da8c0\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition ppd-e7c391536e9fc6ff50198d09558da8c0</b></p><a name=\"ppd-e7c391536e9fc6ff50198d09558da8c0\"> </a><a name=\"hcppd-e7c391536e9fc6ff50198d09558da8c0\"> </a><a name=\"ppd-e7c391536e9fc6ff50198d09558da8c0-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/18/1341/001\u00a0(use:\u00a0official,\u00a0)</p><p><b>name</b>: Ogivri 150 mg powder for concentrate for solution for infusion 1</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000155527}\">Chemical Medicinal Product</span></p><p><b>packageFor</b>: <a href=\"Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#MedicinalProductDefinition_mpaae8d931abe2f2d9085b87555b9bb088\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>statusDate</b>: 2015-02-07 13:28:17+0000</p><p><b>containedItemQuantity</b>: 150 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073498}\">Box</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000003529}\">Cardboard</span></p><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/123456</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073563}\">Vial</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000003204}\">Glass type I</span></p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#ManufacturedItemDefinition_mid-5af3df1132d20d744a88dab06e924e5e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></td></tr></table></blockquote></blockquote></blockquote></div>"
},
"identifier" : [
{
"use" : "official",
"system" : "https://spor.ema.europa.eu/pmswi",
"value" : "EU/1/18/1341/001"
}
],
"name" : "Ogivri 150 mg powder for concentrate for solution for infusion 1",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000155527",
"display" : "Chemical Medicinal Product"
}
]
},
"packageFor" : [
{
"reference" : "MedicinalProductDefinition/mpaae8d931abe2f2d9085b87555b9bb088"
}
],
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "Active"
}
]
},
"statusDate" : "2015-02-07T13:28:17Z",
"containedItemQuantity" : [
{
"value" : 150,
"system" : "http://unitsofmeasure.org",
"code" : "mg"
}
],
"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" : "100000073563",
"display" : "Vial"
}
]
},
"quantity" : 1,
"material" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000003204",
"display" : "Glass type I"
}
]
}
],
"containedItem" : [
{
"item" : {
"reference" : {
"reference" : "ManufacturedItemDefinition/mid-5af3df1132d20d744a88dab06e924e5e"
}
}
}
]
}
]
}
}
},
{
"fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mpaae8d931abe2f2d9085b87555b9bb088",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "mpaae8d931abe2f2d9085b87555b9bb088",
"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_mpaae8d931abe2f2d9085b87555b9bb088\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mpaae8d931abe2f2d9085b87555b9bb088</b></p><a name=\"mpaae8d931abe2f2d9085b87555b9bb088\"> </a><a name=\"hcmpaae8d931abe2f2d9085b87555b9bb088\"> </a><a name=\"mpaae8d931abe2f2d9085b87555b9bb088-en-US\"> </a><p><b>identifier</b>: <code>https://www.who-umc.org/phpid/4</code>/7532F47F36A3585D1F348BBDDA057862</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}\">Medicinal Product</span></p><p><b>domain</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-domain Human}\">Human use</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">active</span></p><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072084}\">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Ogivri 150 mg powder for concentrate for solution for infusion</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}\">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: Ogivri</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: trastuzumab</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}\">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 150 mg</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: powder for concentrate for solution for infusion</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}\">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 NOR}\">Norway</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 NOR}\">Norway</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 en}\">English</span></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "https://www.who-umc.org/phpid/4",
"value" : "7532F47F36A3585D1F348BBDDA057862"
}
],
"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" : "Ogivri 150 mg powder for concentrate for solution for infusion",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000001",
"display" : "Full name"
}
]
},
"part" : [
{
"part" : "Ogivri",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000002",
"display" : "Invented name part"
}
]
}
},
{
"part" : "trastuzumab",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000003",
"display" : "Scientific name part"
}
]
}
},
{
"part" : "150 mg",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000004",
"display" : "Strength part"
}
]
}
},
{
"part" : "powder for concentrate for solution for infusion",
"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" : "NOR",
"display" : "Norway"
}
]
},
"jurisdiction" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "NOR",
"display" : "Norway"
}
]
},
"language" : {
"coding" : [
{
"system" : "urn:ietf:bcp:47",
"code" : "en",
"display" : "English"
}
]
}
}
]
}
]
}
},
{
"fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-5af3df1132d20d744a88dab06e924e5e",
"resource" : {
"resourceType" : "ManufacturedItemDefinition",
"id" : "mid-5af3df1132d20d744a88dab06e924e5e",
"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-5af3df1132d20d744a88dab06e924e5e\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition mid-5af3df1132d20d744a88dab06e924e5e</b></p><a name=\"mid-5af3df1132d20d744a88dab06e924e5e\"> </a><a name=\"hcmid-5af3df1132d20d744a88dab06e924e5e\"> </a><a name=\"mid-5af3df1132d20d744a88dab06e924e5e-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/18/1341/001\u00a0(use:\u00a0official,\u00a0)</p><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi/ 100000074029}\">Powder for concentrate for solution for infusion</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000002158}\">Vial</span></p></div>"
},
"identifier" : [
{
"use" : "official",
"system" : "https://spor.ema.europa.eu/pmswi",
"value" : "EU/1/18/1341/001"
}
],
"status" : "active",
"manufacturedDoseForm" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi/",
"code" : "100000074029",
"display" : "Powder for concentrate for solution for infusion"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000002158",
"display" : "Vial"
}
]
}
}
}
]
}
IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.gh#0.1.0 based on FHIR 5.0.0. Generated 2024-11-20
Links: Table of Contents |
QA Report
The Gravitate Health project has received funding from the IMI 2 Joint Undertaking under grant agreement No 945334.
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.
