R6 Ballot (2nd Draft)

Publish-box (todo)

Example MedicinalProductDefinition/equilidem-with-ing-and-auth (JSON)

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: No 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",
    "status" : "active",
    "for" : [{
      "reference" : "#"
    }],
    "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" : [{
        "presentationRatio" : {
          "numerator" : {
            "value" : 22,
            "unit" : "ml",
            "system" : "http://unitsofmeasure.org",
            "code" : "mL"
          },
          "denominator" : {
            "value" : 1,
            "unit" : "tablet"
          }
        }
      }]
    }
  },
  {
    "resourceType" : "Ingredient",
    "id" : "CalciumCarbonate",
    "status" : "active",
    "for" : [{
      "reference" : "#"
    }],
    "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" : [{
        "presentationRatio" : {
          "numerator" : {
            "value" : 3,
            "unit" : "ml",
            "system" : "http://unitsofmeasure.org",
            "code" : "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"
    }]
  }],
  "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.