Release 5 Preview #3

This page is part of the FHIR Specification (v4.5.0: R5 Preview #3). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

Medicinalproductdefinition-example-equilidem-using-ingredient-and-auth.json

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: Not linked to any defined compartments

Raw JSON (canonical form + also see JSON Format Specification)

Simple version of a product (more than basic), only using MedicinalProductDefinition, Ingredient and RegulatedAuthorization

{
  "resourceType": "MedicinalProductDefinition",
  "id": "equilidem-with-ing-and-auth",
  "text": {
    "status": "generated",
    "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>id</b>: equilidem-with-ing-and-auth</p><p><b>identifier</b>: id: Equilidem25</p><p><b>combinedPharmaceuticalDoseForm</b>: <span>tablet</span></p><p><b>indication</b>: Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class &gt;= II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.</p><p><b>legalStatusOfSupply</b>: <span>Prescription only medicine</span></p><p><b>classification</b>: <span>B01A</span></p><p><b>ingredient</b>: </p><ul><li><a> </a></li><li><a> </a></li></ul><blockquote><p><b>id</b>: EquilidoniumPhosphate</p><p><b>role</b>: <span>active</span></p><blockquote><p><b>substance</b></p><p><b>code</b>: <span>Equilidonium Phosphate</span></p><h3>Strengths</h3><table><tr><td>-</td><td><b>Presentation</b></td></tr><tr><td>*</td><td>22 ml/1 tablet</td></tr></table></blockquote></blockquote><blockquote><p><b>id</b>: CalciumCarbonate</p><p><b>role</b>: <span>excipient</span></p><blockquote><p><b>substance</b></p><p><b>code</b>: <span>Calcium Carbonate</span></p><h3>Strengths</h3><table><tr><td>-</td><td><b>Presentation</b></td></tr><tr><td>*</td><td>3 ml/1 tablet</td></tr></table></blockquote></blockquote><h3>Names</h3><table><tr><td>-</td><td><b>ProductName</b></td></tr><tr><td>*</td><td>Equilidem 2.5 mg film-coated tablets</td></tr></table><h3>CrossReferences</h3><table><tr><td>-</td><td><b>Product</b></td></tr><tr><td>*</td><td/></tr></table><h3>ManufacturingBusinessOperations</h3><table><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><span>EquiliDrugCo Processing Inc.</span></td></tr></table></div>"
  },
  "contained": [
    {
      "resourceType": "Ingredient",
      "id": "EquilidoniumPhosphate",
      "role": {
        "coding": [
          {
            "system": "http://example.org.uk/fhir/ingredientType",
            "code": "active"
          }
        ]
      },
      "substance": {
        "codeCodeableConcept": {
          "coding": [
            {
              "system": "http://example.org.uk/fhir/substances",
              "code": "123456",
              "display": "Equilidonium Phosphate"
            }
          ]
        },
        "strength": [
          {
            "presentation": {
              "numerator": {
                "value": 22,
                "unit": "ml"
              },
              "denominator": {
                "value": 1,
                "unit": "tablet"
              }
            }
          }
        ]
      }
    },
    {
      "resourceType": "Ingredient",
      "id": "CalciumCarbonate",
      "role": {
        "coding": [
          {
            "system": "http://example.org.uk/fhir/ingredientType",
            "code": "excipient"
          }
        ]
      },
      "substance": {
        "codeCodeableConcept": {
          "coding": [
            {
              "system": "http://example.org.uk/fhir/substances",
              "code": "456789",
              "display": "Calcium Carbonate"
            }
          ]
        },
        "strength": [
          {
            "presentation": {
              "numerator": {
                "value": 3,
                "unit": "ml"
              },
              "denominator": {
                "value": 1,
                "unit": "tablet"
              }
            }
          }
        ]
      }
    }
  ],
  "identifier": [
    {
      "system": "http://example.org.uk/fhir/product",
      "value": "Equilidem25"
    }
  ],
  "combinedPharmaceuticalDoseForm": {
    "coding": [
      {
        "system": "http://example.org.uk/fhir/dosefom",
        "code": "tablet"
      }
    ]
  },
  "indication": "Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class >= II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.",
  "legalStatusOfSupply": {
    "coding": [
      {
        "system": "http://example.org.uk/fhir/legalstatusofsupply",
        "code": "POM",
        "display": "Prescription only medicine"
      }
    ]
  },
  "classification": [
    {
      "coding": [
        {
          "system": "http://www.whocc.no/atc/example",
          "code": "B01A"
        }
      ]
    }
  ],
  "ingredient": [
    {
      "reference": "#EquilidoniumPhosphate"
    },
    {
      "reference": "#CalciumCarbonate"
    }
  ],
  "name": [
    {
      "productName": "Equilidem 2.5 mg film-coated tablets"
    }
  ],
  "crossReference": [
    {
      "product": {
        "reference": {
          "reference": "MedicinalProductDefinition/genericEquilidonium"
        }
      }
    }
  ],
  "manufacturingBusinessOperation": [
    {
      "manufacturer": [
        {
          "display": "EquiliDrugCo Processing Inc."
        }
      ]
    }
  ]
}

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.