SMART Product Dataset for Prequalified Vaccines
0.2.0 - ci-build
SMART Product Dataset for Prequalified Vaccines, published by WHO. This guide is not an authorized publication; it is the continuous build for version 0.2.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/litlfred/smart-pcmt-vaxprequal/ and changes regularly. See the Directory of published versions
This content is an example of the WHO Vaccine PreQual DB - Finished Vaccine Products Logical Model and is not a FHIR Resource
{
"resourceType": "http://smart.who.int/pcmt-vaxprequal/StructureDefinition/FinishedVaccineProducts",
"productType": "FinishedVaccineProduct",
"dateOfPrequal": "1993-02-15",
"assessmentProcedure": "PrequalificationStandard",
"status": "Prequalified",
"pharmaceuticalForm": "Lyophilisedactivecomponenttobereconstitutedwithexcipientdiluentbeforeuse",
"presentation": {
"coding": [
{
"system": "https://extranet.who.int/prequal/vaccines/prequalified-vaccines",
"code": "Vial",
"display": "Vial"
}
]
},
"numDoses": 1,
"productId": {
"system": "https://extranet.who.int/prequal/api",
"value": "a3K3X000006MiiMUAS"
},
"productName": "FVP-P-145",
"vaccineFullName": "Measles vaccine (live, attenuated)",
"vaccineAbbreviatedName": "M",
"vaccineCommercialName": "Measles Vaccine Live Attenuated",
"vaccineTypeId": {
"system": "https://extranet.who.int/prequal/api",
"value": "a3S3X000003cSpZUAU"
},
"routeOfAdministration": "Subcutaneous",
"vialMonitor": "Type 14",
"applicantId": {
"system": "https://extranet.who.int/prequal/api",
"value": "0013X00003cPkzfQAC"
},
"applicantName": "Serum Institute of India",
"nraId": {
"system": "https://extranet.who.int/prequal/api",
"value": "0013X0000498p4fQAA"
},
"nraName": "Central Drugs Standard Control Organization (CDSCO)",
"nraCountry": "India",
"shelfLife": "30 months",
"storageTemperature": "2 - 8°C",
"diluent": "Water for injection",
"lastPublishingDate": "2024-09-10",
"publishingRemarks": "An extension of shelf life at 2-8°C from 24 to 30 months was approved on 10 January 2018 and the Product Insert (PI) indicating this shelf life is part of this web listing. However for some time stock on-hand manufactured before this approval date may be supplied and the PI for these batches will still indicated a 24 month shelf life.",
"manufacturerReference": {
"reference": "Organization/Manufacturer0013X00003cPkzfQAC"
},
"responsibleNRAReference": {
"reference": "Organization/Holder0013X0000498p4fQAA"
},
"manufacturerLM": {
"reference": "http://smart.who.int/pcmt-vaxprequal/StructureDefinition/PreQualManufacturer/PreQualManufacturer0013X00003cPkzfQAC"
},
"nraLM": {
"reference": "http://smart.who.int/pcmt-vaxprequal/StructureDefinition/PreQualNRA/PreQualNRA0013X0000498p4fQAA"
},
"vaccineLM": {
"reference": "http://smart.who.int/pcmt-vaxprequal/StructureDefinition/PreQualVaccine/PreQualVaccinea3S3X000003cSpZUAU"
},
"packagingLM": [
{
"reference": "http://smart.who.int/pcmt-vaxprequal/StructureDefinition/PreQualProductPackaging/PreQualPackaginga3H3X000001VabVUAS"
}
],
"documentLM": [
{
"reference": "http://smart.who.int/pcmt-vaxprequal/StructureDefinition/PreQualDocumentDetail/PreQualDocument069NN000005iLnTYAU"
}
],
"siteLM": [
{
"reference": "http://smart.who.int/pcmt-vaxprequal/StructureDefinition/PreQualSiteDetail/PreQualSite0013X00003cPkzfQAC"
}
],
"ingredientLM": [
{
"reference": "http://smart.who.int/pcmt-vaxprequal/StructureDefinition/PreQualProductIngredient/PreQualIngredienta3K3X000006MiiMUASIng2"
}
]
}