Release 5 Preview #3

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\">\n\t\t\t<p>\n\t\t\t\t<b>\n\t\t\t\t\tGenerated Narrative\n\t\t\t\t</b>\n\t\t\t</p>\n\t\t\t<p>\n\t\t\t\t<b>\n\t\t\t\t\tId\n\t\t\t\t</b>\n\t\t\t\t: equilidem-with-ing-and-auth\n\t\t\t</p>\n\t\t\t<p>\n\t\t\t\t<b>\n\t\t\t\t\tIdentifier\n\t\t\t\t</b>\n\t\t\t\t: Equilidem25\n\t\t\t</p>\n\t\t\t<p>\n\t\t\t\t<b>\n\t\t\t\t\tCombined Pharmaceutical Dose Form\n\t\t\t\t</b>\n\t\t\t\t:\n\t\t\t\t<span title=\"Codes: {http://example.org.uk/fhir/dosefom tablet}\">\n\t\t\t\t\ttablet\n\t\t\t\t</span>\n\t\t\t</p>\n\t\t\t<p>\n\t\t\t\t<b>\n\t\t\t\t\tIndication\n\t\t\t\t</b>\n\t\t\t\t: 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.\n\t\t\t</p>\n\t\t\t<p>\n\t\t\t\t<b>\n\t\t\t\t\tLegal Status Of Supply\n\t\t\t\t</b>\n\t\t\t\t:\n\t\t\t\t<span title=\"Codes: {http://example.org.uk/fhir/legalstatusofsupply POM}\">\n\t\t\t\t\tPrescription only medicine\n\t\t\t\t</span>\n\t\t\t</p>\n\t\t\t<p>\n\t\t\t\t<b>\n\t\t\t\t\tclassification\n\t\t\t\t</b>\n\t\t\t\t:\n\t\t\t\t<span title=\"Codes: {http://www.whocc.no/atc/example B01A}\">\n\t\t\t\t\tB01A\n\t\t\t\t</span>\n\t\t\t</p>\n\t\t\t<p>\n\t\t\t\t<b>\n\t\t\t\t\tIngredients\n\t\t\t\t</b>\n\t\t\t\t:\n\t\t\t</p>\n\t\t\t<blockquote>\n\t\t\t\t<p>\n\t\t\t\t\t<b>\n\t\t\t\t\t\tRole\n\t\t\t\t\t</b>\n\t\t\t\t\t:\n\t\t\t\t\t<span title=\"Codes: {http://example.org.uk/fhir/ingredientType active}\">\n\t\t\t\t\t\tactive\n\t\t\t\t\t</span>\n\t\t\t\t</p>\n\t\t\t\t<blockquote>\n\t\t\t\t\t<p>\n\t\t\t\t\t\t<b>\n\t\t\t\t\t\t\tsubstance\n\t\t\t\t\t\t</b>\n\t\t\t\t\t\t:\n\t\t\t\t\t\t<span title=\"Codes: {http://example.org.uk/fhir/substances 123456}\">\n\t\t\t\t\t\t\tEquilidonium Phosphate\n\t\t\t\t\t\t</span>\n\t\t\t\t\t</p>\n\t\t\t\t\t<table class=\"grid\">\n\t\t\t\t\t\t<tr>\n\t\t\t\t\t\t\t<td>\n\t\t\t\t\t\t\t\t-\n\t\t\t\t\t\t\t</td>\n\t\t\t\t\t\t\t<td>\n\t\t\t\t\t\t\t\t<b>\n\t\t\t\t\t\t\t\t\tPresentation\n\t\t\t\t\t\t\t\t</b>\n\t\t\t\t\t\t\t</td>\n\t\t\t\t\t\t</tr>\n\t\t\t\t\t\t<tr>\n\t\t\t\t\t\t\t<td>\n\t\t\t\t\t\t\t\t*\n\t\t\t\t\t\t\t</td>\n\t\t\t\t\t\t\t<td>\n\t\t\t\t\t\t\t\t22 ml/1 tablet\n\t\t\t\t\t\t\t</td>\n\t\t\t\t\t\t</tr>\n\t\t\t\t\t</table>\n\t\t\t\t</blockquote>\n\t\t\t</blockquote>\n\t\t\t<blockquote>\n\t\t\t\t<p>\n\t\t\t\t\t<b>\n\t\t\t\t\t\tRole\n\t\t\t\t\t</b>\n\t\t\t\t\t:\n\t\t\t\t\t<span title=\"Codes: {http://example.org.uk/fhir/ingredientType excipient}\">\n\t\t\t\t\t\texcipient\n\t\t\t\t\t</span>\n\t\t\t\t</p>\n\t\t\t\t<blockquote>\n\t\t\t\t\t<p>\n\t\t\t\t\t\t<b>\n\t\t\t\t\t\t\tsubstance\n\t\t\t\t\t\t</b>\n\t\t\t\t\t\t:\n\t\t\t\t\t\t<span title=\"Codes: {http://example.org.uk/fhir/substances 456789}\">\n\t\t\t\t\t\t\tCalcium Carbonate\n\t\t\t\t\t\t</span>\n\t\t\t\t\t</p>\n\t\t\t\t\t<table class=\"grid\">\n\t\t\t\t\t\t<tr>\n\t\t\t\t\t\t\t<td>\n\t\t\t\t\t\t\t\t-\n\t\t\t\t\t\t\t</td>\n\t\t\t\t\t\t\t<td>\n\t\t\t\t\t\t\t\t<b>\n\t\t\t\t\t\t\t\t\tPresentation\n\t\t\t\t\t\t\t\t</b>\n\t\t\t\t\t\t\t</td>\n\t\t\t\t\t\t</tr>\n\t\t\t\t\t\t<tr>\n\t\t\t\t\t\t\t<td>\n\t\t\t\t\t\t\t\t*\n\t\t\t\t\t\t\t</td>\n\t\t\t\t\t\t\t<td>\n\t\t\t\t\t\t\t\t3 ml/tablet\n\t\t\t\t\t\t\t</td>\n\t\t\t\t\t\t</tr>\n\t\t\t\t\t</table>\n\t\t\t\t</blockquote>\n\t\t\t</blockquote>\n\t\t\t<h3>\n\t\t\t\tNames\n\t\t\t</h3>\n\t\t\t<table class=\"grid\">\n\t\t\t\t<tr>\n\t\t\t\t\t<td>\n\t\t\t\t\t\t-\n\t\t\t\t\t</td>\n\t\t\t\t\t<td>\n\t\t\t\t\t\t<b>\n\t\t\t\t\t\t\tProductName\n\t\t\t\t\t\t</b>\n\t\t\t\t\t</td>\n\t\t\t\t</tr>\n\t\t\t\t<tr>\n\t\t\t\t\t<td>\n\t\t\t\t\t\t*\n\t\t\t\t\t</td>\n\t\t\t\t\t<td>\n\t\t\t\t\t\tEquilidem 2.5 mg film-coated tablets\n\t\t\t\t\t</td>\n\t\t\t\t</tr>\n\t\t\t</table>\n\t\t\t<h3>\n\t\t\t\tCross References\n\t\t\t</h3>\n\t\t\t<table class=\"grid\">\n\t\t\t\t<tr>\n\t\t\t\t\t<td>\n\t\t\t\t\t\t-\n\t\t\t\t\t</td>\n\t\t\t\t\t<td>\n\t\t\t\t\t\t<b>\n\t\t\t\t\t\t\tProduct\n\t\t\t\t\t\t</b>\n\t\t\t\t\t</td>\n\t\t\t\t</tr>\n\t\t\t\t<tr>\n\t\t\t\t\t<td>\n\t\t\t\t\t\t*\n\t\t\t\t\t</td>\n\t\t\t\t\t<td>\n\t\t\t\t\t\tLink to generic equivalent\n\t\t\t\t\t</td>\n\t\t\t\t</tr>\n\t\t\t</table>\n\t\t\t<h3>\n\t\t\t\tManufacturing Business Operations\n\t\t\t</h3>\n\t\t\t<table class=\"grid\">\n\t\t\t\t<tr>\n\t\t\t\t\t<td>\n\t\t\t\t\t\t-\n\t\t\t\t\t</td>\n\t\t\t\t\t<td>\n\t\t\t\t\t\t<b>\n\t\t\t\t\t\t\tManufacturer\n\t\t\t\t\t\t</b>\n\t\t\t\t\t</td>\n\t\t\t\t</tr>\n\t\t\t\t<tr>\n\t\t\t\t\t<td>\n\t\t\t\t\t\t*\n\t\t\t\t\t</td>\n\t\t\t\t\t<td>\n\t\t\t\t\t\t<span>\n\t\t\t\t\t\t\tEquiliDrugCo Processing Inc.\n\t\t\t\t\t\t</span>\n\t\t\t\t\t</td>\n\t\t\t\t</tr>\n\t\t\t</table>\n\t\t</div>"
  },
  "contained": [
    {
      "resourceType": "Ingredient",
      "id": "EquilidoniumPhosphate",
      "role": {
        "coding": [
          {
            "system": "http://example.org.uk/fhir/ingredientType",
            "code": "active"
          }
        ]
      },
      "substance": {
        "code": {
          "concept": {
            "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": {
        "code": {
          "concept": {
            "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": {
        "reference": "#EquilidoniumPhosphate"
      }
    },
    {
      "reference": {
        "reference": "#CalciumCarbonate"
      }
    }
  ],
  "name": [
    {
      "productName": "Equilidem 2.5 mg film-coated tablets"
    }
  ],
  "crossReference": [
    {
      "product": {
        "reference": {
          "reference": "MedicinalProductDefinition/genericEquilidonium"
        }
      }
    }
  ],
  "operation": [
    {
      "organization": [
        {
          "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.