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 |
<Composition xmlns="http://hl7.org/fhir">
<id value="composition-epi-type3-example-wonderdrug"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2023-10-27T10:00:00Z"/>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>WonderDrug Summary of Product Characteristics</p></div>
</text>
<contained>
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<id value="binaryImage-t3"/>
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</Binary>
</contained>
<identifier>
<system value="http://example.org/identifier"/>
<value value="composition-epi-type3-example-wonderdrug"/>
</identifier>
<version value="1.0"/>
<status value="final"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000155532"/>
<display value="Summary of Product Characteristics"/>
</coding>
</type>
<subject>🔗
<reference
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug"/>
</subject>
<date value="2023-10-27"/>
<author>🔗
<reference value="Organization/org-epi-type3-example-pharma"/>
</author>
<title
value="WonderDrug 500 mg tablets - Summary of Product Characteristics"/>
<section id="a5529da2-d8b6-416c-907a-2f6486a49264">
<title value="SUMMARY OF PRODUCT CHARACTERISTICS"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029791"/>
<display value="SUMMARY OF PRODUCT CHARACTERISTICS"/>
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</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en">Summary of Product Characteristics for WonderDrug</div>
</text>
<section id="9f516bb9-8648-4564-883d-885d6d3c8964">
<title value="1. NAME OF THE MEDICINAL PRODUCT"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029792"/>
<display value="1. NAME OF THE MEDICINAL PRODUCT"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>WonderDrug 500 mg tablets</p></div>
</text>
</section>
<section id="9859f8c7-0e7c-4b23-a643-16c907e99041">
<title value="2. QUALITATIVE AND QUANTITATIVE COMPOSITION"/>
<code>
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<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029793"/>
<display value="2. QUALITATIVE AND QUANTITATIVE COMPOSITION"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Each tablet contains 500 mg of paracetamol.</p></div>
</text>
<section id="163ef829-7ba3-486f-85e7-2a0c8d6e03d9">
<title value="2.1 General description"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029794"/>
<display value="2.1 General description"/>
</coding>
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<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>White, round, biconvex tablets.</p></div>
</text>
</section>
<section id="4adc7d65-1c20-4f6b-871a-8f412de5d2a4">
<title value="2.2 Qualitative and quantitative composition"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029795"/>
<display value="2.2 Qualitative and quantitative composition"/>
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</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Each tablet contains 500 mg paracetamol.</p></div>
</text>
</section>
<section id="58eac29a-da40-491a-a068-09f622fbe455">
<title value="Excipient(s) with known effect"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029796"/>
<display value="Excipient(s) with known effect"/>
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</code>
<text>
<status value="generated"/>
<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>
</text>
</section>
</section>
<section id="c29ca0cb-6b4b-40b6-9362-804a2d42cd2d">
<title value="3. PHARMACEUTICAL FORM"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029797"/>
<display value="3. PHARMACEUTICAL FORM"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Tablet. White, round, biconvex tablets.</p></div>
</text>
</section>
<section id="c36bb7fe-be38-4acc-ad4b-9dd188752ca8">
<title value="4. CLINICAL PARTICULARS"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029798"/>
<display value="4. CLINICAL PARTICULARS"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Clinical information about WonderDrug.</p></div>
</text>
<section id="339c6a45-06ea-48d7-9eef-ca80a6c284d5">
<title value="4.1 Therapeutic indications"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029799"/>
<display value="4.1 Therapeutic indications"/>
</coding>
</code>
<text>
<status value="generated"/>
<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>
</text>
</section>
<section id="efd69da5-2510-445d-a59d-261632a92cec">
<title value="4.2 Posology and method of administration"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029800"/>
<display value="4.2 Posology and method of administration"/>
</coding>
</code>
<text>
<status value="generated"/>
<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>
</text>
</section>
<section id="477becff-ccc3-4f82-ac9b-d91a8ba4ace3">
<title value="4.3 Contraindications"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029805"/>
<display value="4.3 Contraindications"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Hypersensitivity to paracetamol or any of the excipients.</p></div>
</text>
</section>
<section id="1878af14-22b3-4da4-aea8-0bfad72e101e">
<title value="4.4 Special warnings and precautions for use"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029806"/>
<display value="4.4 Special warnings and precautions for use"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Caution in patients with hepatic or renal impairment.</p></div>
</text>
</section>
<section id="f3f877bf-322c-4823-bccc-d597f34e1168">
<title
value="4.5 Interaction with other medicinal products and other forms of interaction"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029809"/>
<display
value="4.5 Interaction with other medicinal products and other forms of interaction"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Anticoagulants: Enhanced effect of warfarin with prolonged use.</p></div>
</text>
</section>
<section id="fd945cc2-f076-4f7e-bae0-b1dcd4279854">
<title value="4.6 Fertility, pregnancy and lactation"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029811"/>
<display value="4.6 Fertility, pregnancy and lactation"/>
</coding>
</code>
<text>
<status value="generated"/>
<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>
</text>
</section>
<section id="2ee553da-6e3d-4033-b351-16b624d57bdf">
<title value="4.7 Effects on ability to drive and use machines"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029815"/>
<display
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</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>No known effect.</p></div>
</text>
</section>
<section id="9bfa53f3-3404-459e-97ab-7e090ffc2812">
<title value="4.8 Undesirable effects"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029816"/>
<display value="4.8 Undesirable effects"/>
</coding>
</code>
<text>
<status value="generated"/>
<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>
</text>
</section>
<section id="0c762653-f91a-42c9-a5ae-5ec2d46eebf4">
<title value="4.9 Overdose"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029819"/>
<display value="4.9 Overdose"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Symptoms: Hepatic damage. Treatment: N-acetylcysteine.</p></div>
</text>
</section>
</section>
<section id="163e3b46-07f3-428f-9015-563df3345349">
<title value="5. PHARMACOLOGICAL PROPERTIES"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029821"/>
<display value="5. PHARMACOLOGICAL PROPERTIES"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Pharmacological properties of WonderDrug.</p></div>
</text>
<section id="1aa4d0d4-2137-4cd8-ac7f-d6f910eebcfb">
<title value="5.1 Pharmacodynamic properties"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029822"/>
<display value="5.1 Pharmacodynamic properties"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Pharmacotherapeutic group: Analgesics, ATC code: N02BE01.</p></div>
</text>
</section>
<section id="1fa3fb24-9319-4a6a-ab27-09e99372c584">
<title value="5.2 Pharmacokinetic properties"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029827"/>
<display value="5.2 Pharmacokinetic properties"/>
</coding>
</code>
<text>
<status value="generated"/>
<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>
</text>
</section>
<section id="1ddebeef-c6c6-4466-ba94-ded89fbfb7ab">
<title value="5.3 Preclinical safety data"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029834"/>
<display value="5.3 Preclinical safety data"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>No additional data of relevance.</p></div>
</text>
</section>
</section>
<section id="3354d395-ff4f-4cf2-9715-79d1572c5bd8">
<title value="6. PHARMACEUTICAL PARTICULARS"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029836"/>
<display value="6. PHARMACEUTICAL PARTICULARS"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Pharmaceutical particulars for WonderDrug.</p></div>
</text>
<section id="1810edbd-e273-47ca-ac6d-95da39cbbf65">
<title value="6.1 List of excipients"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029837"/>
<display value="6.1 List of excipients"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Pregelatinised starch, maize starch, magnesium stearate.</p></div>
</text>
</section>
<section id="92f549e6-2502-4a47-a0b2-d15481e5173b">
<title value="6.2 Incompatibilities"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029838"/>
<display value="6.2 Incompatibilities"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Not applicable.</p></div>
</text>
</section>
<section id="29fb1695-4488-4e67-863b-ea8c0ce4d53d">
<title value="6.3 Shelf life"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029839"/>
<display value="6.3 Shelf life"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>3 years.</p></div>
</text>
</section>
<section id="5d7ccb0a-ad90-4497-acbf-80d4f75dce83">
<title value="6.4 Special precautions for storage"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029840"/>
<display value="6.4 Special precautions for storage"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Store below 25°C.</p></div>
</text>
</section>
<section id="c6299d8a-2062-40b4-bac1-d2076f43cdac">
<title value="6.5 Nature and contents of container"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029841"/>
<display value="6.5 Nature and contents of container"/>
</coding>
</code>
<text>
<status value="generated"/>
<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>
</text>
</section>
<section id="51d4458e-096d-4980-9d3a-6efd9e72185f">
<title value="6.6 Special precautions for disposal"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029842"/>
<display value="6.6 Special precautions for disposal"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>No special requirements.</p></div>
</text>
</section>
</section>
<section id="547a1ef0-952a-4dc0-8dc8-583445d2c680">
<title value="7. MARKETING AUTHORISATION HOLDER"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029844"/>
<display value="7. MARKETING AUTHORISATION HOLDER"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>WonderPharma Inc., 123 Pharma Way, Prague, Czech Republic</p></div>
</text>
</section>
<section id="a717d6c2-dd85-47c9-9d0a-06185f400226">
<title value="8. MARKETING AUTHORISATION NUMBER(S)"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029845"/>
<display value="8. MARKETING AUTHORISATION NUMBER(S)"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>EU/1/23/1234/001</p></div>
</text>
</section>
<section id="61b98f40-58f4-4602-97ad-0212e3a5bda2">
<title
value="9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029846"/>
<display
value="9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Date of first authorisation: 15 January 2020</p></div>
</text>
</section>
<section id="a6307678-ce1e-4bf2-b9a0-0b7a566887f7">
<title value="10. DATE OF REVISION OF THE TEXT"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029847"/>
<display value="10. DATE OF REVISION OF THE TEXT"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>October 2023</p></div>
</text>
</section>
</section>
</Composition>
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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