Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
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
| Page standards status: Informative |
{
"resourceType" : "Composition",
"id" : "composition-epi-type3-example-wonderdrug",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2023-10-27T10:00:00Z",
"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>WonderDrug Summary of Product Characteristics</p></div>"
},
"contained" : [
{
"resourceType" : "Binary",
"id" : "binaryImage-t3",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/binary-epi"
]
},
"contentType" : "image/png",
"data" : "iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAQAAAC1HAwCAAAAC0lEQVR42mNkYAAAAAYAAjCB0C8AAAAASUVORK5CYII="
}
],
"identifier" : [
{
"system" : "http://example.org/identifier",
"value" : "composition-epi-type3-example-wonderdrug"
}
],
"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-epi-type3-example-wonderdrug"
}
],
"date" : "2023-10-27",
"author" : [
{
🔗 "reference" : "Organization/org-epi-type3-example-pharma"
}
],
"title" : "WonderDrug 500 mg tablets - Summary of Product Characteristics",
"section" : [
{
"id" : "a5529da2-d8b6-416c-907a-2f6486a49264",
"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 WonderDrug</div>"
},
"section" : [
{
"id" : "9f516bb9-8648-4564-883d-885d6d3c8964",
"title" : "1. NAME OF THE MEDICINAL PRODUCT",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029792",
"display" : "1. NAME OF THE MEDICINAL PRODUCT"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>WonderDrug 500 mg tablets</p></div>"
}
},
{
"id" : "9859f8c7-0e7c-4b23-a643-16c907e99041",
"title" : "2. QUALITATIVE AND QUANTITATIVE COMPOSITION",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029793",
"display" : "2. QUALITATIVE AND QUANTITATIVE COMPOSITION"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Each tablet contains 500 mg of paracetamol.</p></div>"
},
"section" : [
{
"id" : "163ef829-7ba3-486f-85e7-2a0c8d6e03d9",
"title" : "2.1 General description",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029794",
"display" : "2.1 General description"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>White, round, biconvex tablets.</p></div>"
}
},
{
"id" : "4adc7d65-1c20-4f6b-871a-8f412de5d2a4",
"title" : "2.2 Qualitative and quantitative composition",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029795",
"display" : "2.2 Qualitative and quantitative composition"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Each tablet contains 500 mg paracetamol.</p></div>"
}
},
{
"id" : "58eac29a-da40-491a-a068-09f622fbe455",
"title" : "Excipient(s) with known effect",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029796",
"display" : "Excipient(s) with known effect"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>For the full list of excipients, see section 6.1.</p></div>"
}
}
]
},
{
"id" : "c29ca0cb-6b4b-40b6-9362-804a2d42cd2d",
"title" : "3. PHARMACEUTICAL FORM",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029797",
"display" : "3. PHARMACEUTICAL FORM"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Tablet. White, round, biconvex tablets.</p></div>"
}
},
{
"id" : "c36bb7fe-be38-4acc-ad4b-9dd188752ca8",
"title" : "4. CLINICAL PARTICULARS",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029798",
"display" : "4. CLINICAL PARTICULARS"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Clinical information about WonderDrug.</p></div>"
},
"section" : [
{
"id" : "339c6a45-06ea-48d7-9eef-ca80a6c284d5",
"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>Symptomatic treatment of mild to moderate pain and/or fever.</p></div>"
}
},
{
"id" : "efd69da5-2510-445d-a59d-261632a92cec",
"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>Adults: 1-2 tablets every 4-6 hours. Maximum 8 tablets in 24 hours.</p></div>"
}
},
{
"id" : "477becff-ccc3-4f82-ac9b-d91a8ba4ace3",
"title" : "4.3 Contraindications",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029805",
"display" : "4.3 Contraindications"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Hypersensitivity to paracetamol or any of the excipients.</p></div>"
}
},
{
"id" : "1878af14-22b3-4da4-aea8-0bfad72e101e",
"title" : "4.4 Special warnings and precautions for use",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029806",
"display" : "4.4 Special warnings and precautions for use"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Caution in patients with hepatic or renal impairment.</p></div>"
}
},
{
"id" : "f3f877bf-322c-4823-bccc-d597f34e1168",
"title" : "4.5 Interaction with other medicinal products and other forms of interaction",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029809",
"display" : "4.5 Interaction with other medicinal products and other forms of interaction"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Anticoagulants: Enhanced effect of warfarin with prolonged use.</p></div>"
}
},
{
"id" : "fd945cc2-f076-4f7e-bae0-b1dcd4279854",
"title" : "4.6 Fertility, pregnancy and lactation",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029811",
"display" : "4.6 Fertility, pregnancy and lactation"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Can be used during pregnancy and lactation at recommended doses.</p></div>"
}
},
{
"id" : "2ee553da-6e3d-4033-b351-16b624d57bdf",
"title" : "4.7 Effects on ability to drive and use machines",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029815",
"display" : "4.7 Effects on ability to drive and use machines"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>No known effect.</p></div>"
}
},
{
"id" : "9bfa53f3-3404-459e-97ab-7e090ffc2812",
"title" : "4.8 Undesirable effects",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029816",
"display" : "4.8 Undesirable effects"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit. Sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris.</p><p><b>Summary of adverse reactions:</b></p><ul><li>Very common (≥1/10): Nausea, headache</li><li>Common (≥1/100 to <1/10): Dizziness, fatigue</li><li>Uncommon (≥1/1,000 to <1/100): Allergic reactions, skin rash</li><li>Rare (≥1/10,000 to <1/1,000): Hepatotoxicity</li></ul><table border=\"1\"><tr><th>System Organ Class</th><th>Frequency</th><th>Adverse Reaction</th></tr><tr><td>Gastrointestinal</td><td>Very common</td><td>Nausea</td></tr><tr><td>Nervous system</td><td>Very common</td><td>Headache</td></tr><tr><td>Skin</td><td>Uncommon</td><td>Rash, pruritus</td></tr></table><p>Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur.</p><p><img src=\"data:image/svg+xml;base64,PHN2ZyB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciIHdpZHRoPSIxMDAiIGhlaWdodD0iMTAwIj48Y2lyY2xlIGN4PSI1MCIgY3k9IjUwIiByPSI0MCIgc3Ryb2tlPSJibGFjayIgc3Ryb2tlLXdpZHRoPSIzIiBmaWxsPSJyZWQiIC8+PC9zdmc+\" alt=\"Sample SVG Image\"/></p></div>"
}
},
{
"id" : "0c762653-f91a-42c9-a5ae-5ec2d46eebf4",
"title" : "4.9 Overdose",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029819",
"display" : "4.9 Overdose"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Symptoms: Hepatic damage. Treatment: N-acetylcysteine.</p></div>"
}
}
]
},
{
"id" : "163e3b46-07f3-428f-9015-563df3345349",
"title" : "5. PHARMACOLOGICAL PROPERTIES",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029821",
"display" : "5. PHARMACOLOGICAL PROPERTIES"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Pharmacological properties of WonderDrug.</p></div>"
},
"section" : [
{
"id" : "1aa4d0d4-2137-4cd8-ac7f-d6f910eebcfb",
"title" : "5.1 Pharmacodynamic properties",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029822",
"display" : "5.1 Pharmacodynamic properties"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Pharmacotherapeutic group: Analgesics, ATC code: N02BE01.</p></div>"
}
},
{
"id" : "1fa3fb24-9319-4a6a-ab27-09e99372c584",
"title" : "5.2 Pharmacokinetic properties",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029827",
"display" : "5.2 Pharmacokinetic properties"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Rapidly absorbed from the GI tract. Peak plasma concentration in 30-60 minutes.</p></div>"
}
},
{
"id" : "1ddebeef-c6c6-4466-ba94-ded89fbfb7ab",
"title" : "5.3 Preclinical safety data",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029834",
"display" : "5.3 Preclinical safety data"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>No additional data of relevance.</p></div>"
}
}
]
},
{
"id" : "3354d395-ff4f-4cf2-9715-79d1572c5bd8",
"title" : "6. PHARMACEUTICAL PARTICULARS",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029836",
"display" : "6. PHARMACEUTICAL PARTICULARS"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Pharmaceutical particulars for WonderDrug.</p></div>"
},
"section" : [
{
"id" : "1810edbd-e273-47ca-ac6d-95da39cbbf65",
"title" : "6.1 List of excipients",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029837",
"display" : "6.1 List of excipients"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Pregelatinised starch, maize starch, magnesium stearate.</p></div>"
}
},
{
"id" : "92f549e6-2502-4a47-a0b2-d15481e5173b",
"title" : "6.2 Incompatibilities",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029838",
"display" : "6.2 Incompatibilities"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Not applicable.</p></div>"
}
},
{
"id" : "29fb1695-4488-4e67-863b-ea8c0ce4d53d",
"title" : "6.3 Shelf life",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029839",
"display" : "6.3 Shelf life"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>3 years.</p></div>"
}
},
{
"id" : "5d7ccb0a-ad90-4497-acbf-80d4f75dce83",
"title" : "6.4 Special precautions for storage",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029840",
"display" : "6.4 Special precautions for storage"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Store below 25°C.</p></div>"
}
},
{
"id" : "c6299d8a-2062-40b4-bac1-d2076f43cdac",
"title" : "6.5 Nature and contents of container",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029841",
"display" : "6.5 Nature and contents of container"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>PVC/Aluminium blisters. Pack sizes: 10, 20, 30 tablets.</p></div>"
}
},
{
"id" : "51d4458e-096d-4980-9d3a-6efd9e72185f",
"title" : "6.6 Special precautions for disposal",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029842",
"display" : "6.6 Special precautions for disposal"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>No special requirements.</p></div>"
}
}
]
},
{
"id" : "547a1ef0-952a-4dc0-8dc8-583445d2c680",
"title" : "7. MARKETING AUTHORISATION HOLDER",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029844",
"display" : "7. MARKETING AUTHORISATION HOLDER"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>WonderPharma Inc., 123 Pharma Way, Prague, Czech Republic</p></div>"
}
},
{
"id" : "a717d6c2-dd85-47c9-9d0a-06185f400226",
"title" : "8. MARKETING AUTHORISATION NUMBER(S)",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029845",
"display" : "8. MARKETING AUTHORISATION NUMBER(S)"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>EU/1/23/1234/001</p></div>"
}
},
{
"id" : "61b98f40-58f4-4602-97ad-0212e3a5bda2",
"title" : "9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029846",
"display" : "9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Date of first authorisation: 15 January 2020</p></div>"
}
},
{
"id" : "a6307678-ce1e-4bf2-b9a0-0b7a566887f7",
"title" : "10. DATE OF REVISION OF THE TEXT",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029847",
"display" : "10. DATE OF REVISION OF THE TEXT"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>October 2023</p></div>"
}
}
]
}
]
}
IG © 2022+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.emedicinal-product-info#1.1.0 based on FHIR 5.0.0.
Generated
2026-04-03
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