Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use World

Global Core Electronic Medicinal Product Information (ePI), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

: Composition - Diflucan SmPC

Page standards status: Informative

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{
  "resourceType" : "Composition",
  "id" : "composition-diflucan",
  "meta" : {
    "versionId" : "1",
    "lastUpdated" : "2026-06-17T10:00:00Z",
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1"
    ]
  },
  "language" : "en",
  "text" : {
    "status" : "generated",
    "div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Diflucan Summary of Product Characteristics</p></div>"
  },
  "identifier" : [
    {
      "system" : "http://example.org/identifier",
      "value" : "composition-diflucan"
    }
  ],
  "version" : "1.0",
  "status" : "final",
  "type" : {
    "coding" : [
      {
        "system" : "https://spor.ema.europa.eu/rmswi",
        "code" : "100000155532",
        "display" : "Summary of Product Characteristics"
      }
    ]
  },
  "subject" : [
    {
      🔗 "reference" : "http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan"
    }
  ],
  "date" : "2026-06-17",
  "author" : [
    {
      🔗 "reference" : "Organization/org-diflucan"
    }
  ],
  "title" : "Diflucan 150 mg capsule - Summary of Product Characteristics",
  "section" : [
    {
      "id" : "diflucan-root",
      "title" : "SUMMARY OF PRODUCT CHARACTERISTICS",
      "code" : {
        "coding" : [
          {
            "system" : "https://spor.ema.europa.eu/rmswi",
            "code" : "200000029791",
            "display" : "SUMMARY OF PRODUCT CHARACTERISTICS"
          }
        ]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\">Summary of Product Characteristics for Diflucan</div>"
      },
      "section" : [
        {
          "id" : "diflucan-4-1",
          "title" : "4.1 Therapeutic indications",
          "code" : {
            "coding" : [
              {
                "system" : "https://spor.ema.europa.eu/rmswi",
                "code" : "200000029799",
                "display" : "4.1 Therapeutic indications"
              }
            ]
          },
          "text" : {
            "status" : "generated",
            "div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Treatment of mucosal and invasive candidiasis.</p></div>"
          },
          "entry" : [
            {
              🔗 "reference" : "ClinicalUseDefinition/cud-diflucan-mucosal"
            },
            {
              🔗 "reference" : "ClinicalUseDefinition/cud-diflucan-invasive"
            }
          ]
        },
        {
          "id" : "diflucan-4-2",
          "title" : "4.2 Posology and method of administration",
          "code" : {
            "coding" : [
              {
                "system" : "https://spor.ema.europa.eu/rmswi",
                "code" : "200000029800",
                "display" : "4.2 Posology and method of administration"
              }
            ]
          },
          "text" : {
            "status" : "generated",
            "div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Dose depends on the indication and the patient population (see structured dosing). Renal impairment requires dose adjustment for multiple-dose therapy.</p></div>"
          },
          "entry" : [
            {
              🔗 "reference" : "MedicationKnowledge/mk-diflucan"
            },
            {
              🔗 "reference" : "ClinicalUseDefinition/cud-diflucan-renal"
            }
          ]
        }
      ]
    }
  ]
}