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
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<language value="en"/>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="WONDERDRUG-500MG-BUNDLE-TYPE3"/>
</identifier>
<type value="document"/>
<timestamp value="2023-10-27T10:00:00Z"/>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/Composition/composition-epi-type3-example-wonderdrug"/>
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<Composition>
<id value="composition-epi-type3-example-wonderdrug"/>
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<profile
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</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><a name="Composition_composition-epi-type3-example-wonderdrug"> </a><p>WonderDrug Summary of Product Characteristics</p></div>
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<value value="composition-epi-type3-example-wonderdrug"/>
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<status value="final"/>
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<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000155532"/>
<display value="Summary of Product Characteristics"/>
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<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"/>
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<code value="200000029791"/>
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<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"/>
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<code value="200000029792"/>
<display value="1. NAME OF THE MEDICINAL PRODUCT"/>
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<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>WonderDrug 500 mg tablets</p></div>
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</section>
<section id="9859f8c7-0e7c-4b23-a643-16c907e99041">
<title value="2. QUALITATIVE AND QUANTITATIVE COMPOSITION"/>
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<code value="200000029793"/>
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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 of paracetamol.</p></div>
</text>
<section id="163ef829-7ba3-486f-85e7-2a0c8d6e03d9">
<title value="2.1 General description"/>
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<code value="200000029794"/>
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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>
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<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029795"/>
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<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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<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"/>
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<code value="200000029797"/>
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<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"/>
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<code value="200000029798"/>
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<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>
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<code value="200000029799"/>
<display value="4.1 Therapeutic indications"/>
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<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"/>
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<code value="200000029800"/>
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</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"/>
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<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"/>
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</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"/>
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<code value="200000029809"/>
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</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"/>
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<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
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<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>
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<code value="200000029816"/>
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<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>
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<section id="0c762653-f91a-42c9-a5ae-5ec2d46eebf4">
<title value="4.9 Overdose"/>
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<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029819"/>
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<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"/>
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<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"/>
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<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"/>
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<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"/>
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</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>
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<code value="200000029838"/>
<display value="6.2 Incompatibilities"/>
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<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"/>
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<coding>
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<code value="200000029839"/>
<display value="6.3 Shelf life"/>
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<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"/>
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<code value="200000029840"/>
<display value="6.4 Special precautions for storage"/>
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<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Store below 25°C.</p></div>
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</section>
<section id="c6299d8a-2062-40b4-bac1-d2076f43cdac">
<title value="6.5 Nature and contents of container"/>
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<code value="200000029841"/>
<display value="6.5 Nature and contents of container"/>
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<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"/>
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<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029842"/>
<display value="6.6 Special precautions for disposal"/>
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<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"/>
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<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029844"/>
<display value="7. MARKETING AUTHORISATION HOLDER"/>
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</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
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</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"/>
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<code value="200000029847"/>
<display value="10. DATE OF REVISION OF THE TEXT"/>
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<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>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/Organization/org-epi-type3-example-pharma"/>
<resource>
<Organization>
<id value="org-epi-type3-example-pharma"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_org-epi-type3-example-pharma"> </a><p class="res-header-id"><b>Generated Narrative: Organization org-epi-type3-example-pharma</b></p><a name="org-epi-type3-example-pharma"> </a><a name="hcorg-epi-type3-example-pharma"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Organization-uv-epi.html">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/LOC-100000000</p><p><b>active</b>: true</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 220000000034}">Marketing authorisation holder</span></p><p><b>name</b>: WonderPharma Inc.</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Telecom</b></td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td><a href="tel:+420123456789">+420 123 456 789</a>, <a href="mailto:info@wonderpharma.example.com">info@wonderpharma.example.com</a>, <a href="https://www.wonderpharma.example.com">https://www.wonderpharma.example.com</a></td><td>WonderPharma Inc., 123 Pharma Way, Prague 10, 102 37, Czech Republic</td></tr></table></div>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/omswi"/>
<value value="LOC-100000000"/>
</identifier>
<active value="true"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="220000000034"/>
<display value="Marketing authorisation holder"/>
</coding>
</type>
<name value="WonderPharma Inc."/>
<contact>
<telecom>
<system value="phone"/>
<value value="+420 123 456 789"/>
</telecom>
<telecom>
<system value="email"/>
<value value="info@wonderpharma.example.com"/>
</telecom>
<telecom>
<system value="url"/>
<value value="https://www.wonderpharma.example.com"/>
</telecom>
<address>
<type value="both"/>
<text
value="WonderPharma Inc., 123 Pharma Way, Prague 10, 102 37, Czech Republic"/>
<line value="123 Pharma Way"/>
<city value="Prague"/>
<district value="Prague 10"/>
<state value="Central Bohemia"/>
<postalCode value="102 37"/>
<country value="CZ"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug"/>
<resource>
<MedicinalProductDefinition>
<id value="mpd-epi-type3-example-wonderdrug"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mpd-epi-type3-example-wonderdrug"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mpd-epi-type3-example-wonderdrug</b></p><a name="mpd-epi-type3-example-wonderdrug"> </a><a name="hcmpd-epi-type3-example-wonderdrug"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-MedicinalProductDefinition-uv-epi.html">MedicinalProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/WONDERDRUG-500MG</p><p><b>domain</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-domain Human}">Human use</span></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Contact</b></td></tr><tr><td style="display: none">*</td><td><a href="Organization-org-epi-type3-example-pharma.html">Organization WonderPharma Inc.</a></td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: WonderDrug 500 mg tablets</p><blockquote><p><b>part</b></p><p><b>part</b>: WonderDrug</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-name-part-type InventedNamePart}">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 500 mg</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-name-part-type StrengthPart}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: tablets</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-name-part-type DoseFormPart}">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:iso:std:iso:3166 EE}">Estonia</span></td><td><span title="Codes:{urn:ietf:bcp:47 et}">Estonian</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="WONDERDRUG-500MG"/>
</identifier>
<domain>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-domain"/>
<code value="Human"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<contact>
<contact>🔗
<reference value="Organization/org-epi-type3-example-pharma"/>
</contact>
</contact>
<name>
<productName value="WonderDrug 500 mg tablets"/>
<part>
<part value="WonderDrug"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="InventedNamePart"/>
<display value="Invented name part"/>
</coding>
</type>
</part>
<part>
<part value="500 mg"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="StrengthPart"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="tablets"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="DoseFormPart"/>
<display value="Pharmaceutical dose form part"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EE"/>
<display value="Estonia"/>
</coding>
</country>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="et"/>
<display value="Estonian"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type2-example-paracetamol-100mg"/>
<resource>
<MedicinalProductDefinition>
<id value="mpd-epi-type2-example-paracetamol-100mg"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mpd-epi-type2-example-paracetamol-100mg"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mpd-epi-type2-example-paracetamol-100mg</b></p><a name="mpd-epi-type2-example-paracetamol-100mg"> </a><a name="hcmpd-epi-type2-example-paracetamol-100mg"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-MedicinalProductDefinition-uv-epi.html">MedicinalProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/WONDERDRUG-100MG</p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ProductName</b></td></tr><tr><td style="display: none">*</td><td>WonderDrug 100 mg tablets</td></tr></table></div>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="WONDERDRUG-100MG"/>
</identifier>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<name>
<productName value="WonderDrug 100 mg tablets"/>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type2-example-paracetamol-200mg"/>
<resource>
<MedicinalProductDefinition>
<id value="mpd-epi-type2-example-paracetamol-200mg"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mpd-epi-type2-example-paracetamol-200mg"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mpd-epi-type2-example-paracetamol-200mg</b></p><a name="mpd-epi-type2-example-paracetamol-200mg"> </a><a name="hcmpd-epi-type2-example-paracetamol-200mg"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-MedicinalProductDefinition-uv-epi.html">MedicinalProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/WONDERDRUG-200MG</p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ProductName</b></td></tr><tr><td style="display: none">*</td><td>WonderDrug 200 mg tablets</td></tr></table></div>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="WONDERDRUG-200MG"/>
</identifier>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<name>
<productName value="WonderDrug 200 mg tablets"/>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type2-example-paracetamol"/>
<resource>
<MedicinalProductDefinition>
<id value="mpd-epi-type2-example-paracetamol"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mpd-epi-type2-example-paracetamol"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mpd-epi-type2-example-paracetamol</b></p><a name="mpd-epi-type2-example-paracetamol"> </a><a name="hcmpd-epi-type2-example-paracetamol"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-MedicinalProductDefinition-uv-epi.html">MedicinalProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/WONDERDRUG-500MG</p><p><b>domain</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-domain Human}">Human use</span></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>legalStatusOfSupply</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072084}">Medicinal product subject to medical prescription</span></p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Contact</b></td></tr><tr><td style="display: none">*</td><td><a href="Organization-org-epi-type2-example-acme.html">Organization Acme Pharma Inc.</a></td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: WonderDrug 500 mg tablets</p><blockquote><p><b>part</b></p><p><b>part</b>: WonderDrug</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-name-part-type InventedNamePart}">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 500 mg</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-name-part-type StrengthPart}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: tablets</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-name-part-type DoseFormPart}">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:iso:std:iso:3166 EE}">Estonia</span></td><td><span title="Codes:{urn:ietf:bcp:47 et}">Estonian</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="WONDERDRUG-500MG"/>
</identifier>
<domain>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-domain"/>
<code value="Human"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072084"/>
<display
value="Medicinal product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<contact>
<contact>🔗
<reference value="Organization/org-epi-type2-example-acme"/>
</contact>
</contact>
<name>
<productName value="WonderDrug 500 mg tablets"/>
<part>
<part value="WonderDrug"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="InventedNamePart"/>
<display value="Invented name part"/>
</coding>
</type>
</part>
<part>
<part value="500 mg"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="StrengthPart"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="tablets"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="DoseFormPart"/>
<display value="Pharmaceutical dose form part"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EE"/>
<display value="Estonia"/>
</coding>
</country>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="et"/>
<display value="Estonian"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/Organization/org-epi-type2-example-acme"/>
<resource>
<Organization>
<id value="org-epi-type2-example-acme"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_org-epi-type2-example-acme"> </a><p class="res-header-id"><b>Generated Narrative: Organization org-epi-type2-example-acme</b></p><a name="org-epi-type2-example-acme"> </a><a name="hcorg-epi-type2-example-acme"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Organization-uv-epi.html">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/LOC-100000000</p><p><b>active</b>: true</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 220000000034}">Marketing authorisation holder</span></p><p><b>name</b>: Acme Pharma Inc.</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>123 Pharma Way, 102 37 Prague 10, Czech Republic</td></tr></table></div>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/omswi"/>
<value value="LOC-100000000"/>
</identifier>
<active value="true"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="220000000034"/>
<display value="Marketing authorisation holder"/>
</coding>
</type>
<name value="Acme Pharma Inc."/>
<contact>
<address>
<text value="123 Pharma Way, 102 37 Prague 10, Czech Republic"/>
<line value="123 Pharma Way"/>
<city value="Prague"/>
<postalCode value="102 37"/>
<country value="Czech Republic"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/RegulatedAuthorization/ra-epi-type2-example-paracetamol"/>
<resource>
<RegulatedAuthorization>
<id value="ra-epi-type2-example-paracetamol"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_ra-epi-type2-example-paracetamol"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization ra-epi-type2-example-paracetamol</b></p><a name="ra-epi-type2-example-paracetamol"> </a><a name="hcra-epi-type2-example-paracetamol"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-RegulatedAuthorization-uv-epi.html">RegulatedAuthorization (ePI)</a></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/MA-123456789</p><p><b>subject</b>: <a href="Bundle-bundle-epi-type2-example-paracetamol.html#http-//hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type2-example-paracetamol">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 220000000061}">Marketing Authorisation</span></p><p><b>region</b>: <span title="Codes:{urn:iso:std:iso:3166 EE}">Estonia</span></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>holder</b>: <a href="Organization-org-epi-type2-example-acme.html">Organization Acme Pharma Inc.</a></p></div>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="MA-123456789"/>
</identifier>
<subject>🔗
<reference
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type2-example-paracetamol"/>
</subject>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="220000000061"/>
<display value="Marketing Authorisation"/>
</coding>
</type>
<region>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EE"/>
<display value="Estonia"/>
</coding>
</region>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<holder>🔗
<reference value="Organization/org-epi-type2-example-acme"/>
</holder>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/PackagedProductDefinition/ppd-epi-type2-example-paracetamol"/>
<resource>
<PackagedProductDefinition>
<id value="ppd-epi-type2-example-paracetamol"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_ppd-epi-type2-example-paracetamol"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition ppd-epi-type2-example-paracetamol</b></p><a name="ppd-epi-type2-example-paracetamol"> </a><a name="hcppd-epi-type2-example-paracetamol"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PackagedProductDefinition-uv-epi.html">PackagedProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/ppd-epi-type2-example-paracetamol</p><p><b>packageFor</b>: <a href="MedicinalProductDefinition-mpd-epi-type2-example-paracetamol.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073498}">Box</span></p><p><b>quantity</b>: 1</p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073496}">Blister</span></p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="ManufacturedItemDefinition-mid-epi-type2-example-paracetamol.html">ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></td></tr></table><p><b>amount</b>: 30 Tablet</p></blockquote></blockquote></blockquote></div>
</text>
<identifier>
<system value="http://example.org/identifier"/>
<value value="ppd-epi-type2-example-paracetamol"/>
</identifier>
<packageFor>🔗
<reference
value="MedicinalProductDefinition/mpd-epi-type2-example-paracetamol"/>
</packageFor>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<packaging>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<packaging>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073496"/>
<display value="Blister"/>
</coding>
</type>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/mid-epi-type2-example-paracetamol"/>
</reference>
</item>
<amount>
<value value="30"/>
<unit value="Tablet"/>
<system value="http://standardterms.edqm.eu"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/ManufacturedItemDefinition/mid-epi-type2-example-paracetamol"/>
<resource>
<ManufacturedItemDefinition>
<id value="mid-epi-type2-example-paracetamol"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_mid-epi-type2-example-paracetamol"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition mid-epi-type2-example-paracetamol</b></p><a name="mid-epi-type2-example-paracetamol"> </a><a name="hcmid-epi-type2-example-paracetamol"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ManufacturedItemDefinition-uv-epi.html">ManufacturedItemDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/mid-epi-type2-example-paracetamol</p><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073664}">Tablet</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 200000002152}">Tablet</span></p><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig shape}">Shape</span></p><p><b>value</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073670}">Round</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig color}">Color</span></p><p><b>value</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073586}">White</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig size}">Size</span></p><p><b>value</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000000000}">10 mm</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig score}">Score</span></p><p><b>value</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000000000}">Scored</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig imprint}">Imprint</span></p><p><b>value</b>: </p><div><p>WD500</p>
</div></blockquote></div>
</text>
<identifier>
<system value="http://example.org/identifier"/>
<value value="mid-epi-type2-example-paracetamol"/>
</identifier>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073664"/>
<display value="Tablet"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000002152"/>
<display value="Tablet"/>
</coding>
</unitOfPresentation>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="shape"/>
<display value="Shape"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073670"/>
<display value="Round"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="color"/>
<display value="Color"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073586"/>
<display value="White"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="size"/>
<display value="Size"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000000000"/>
<display value="10 mm"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="score"/>
<display value="Score"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000000000"/>
<display value="Scored"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="imprint"/>
<display value="Imprint"/>
</coding>
</type>
<valueMarkdown value="WD500"/>
</property>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/AdministrableProductDefinition/apd-epi-type2-example-paracetamol"/>
<resource>
<AdministrableProductDefinition>
<id value="apd-epi-type2-example-paracetamol"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_apd-epi-type2-example-paracetamol"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition apd-epi-type2-example-paracetamol</b></p><a name="apd-epi-type2-example-paracetamol"> </a><a name="hcapd-epi-type2-example-paracetamol"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-AdministrableProductDefinition-uv-epi.html">AdministrableProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/apd-epi-type2-example-paracetamol</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="MedicinalProductDefinition-mpd-epi-type2-example-paracetamol.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073664}">Tablet</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 200000002152}">Tablet</span></p><p><b>producedFrom</b>: <a href="ManufacturedItemDefinition-mid-epi-type2-example-paracetamol.html">ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig shape}">Shape</span></p><p><b>value</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073670}">Round</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig color}">Color</span></p><p><b>value</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073586}">White</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig flavor}">Flavor</span></p><p><b>value</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000000000}">None</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig image}">Image</span></p><p><b>value</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000000000}">Tablet Image</span></p></blockquote><h3>RouteOfAdministrations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073619}">Oral use</span></td></tr></table></div>
</text>
<identifier>
<system value="http://example.org/identifier"/>
<value value="apd-epi-type2-example-paracetamol"/>
</identifier>
<status value="active"/>
<formOf>🔗
<reference
value="MedicinalProductDefinition/mpd-epi-type2-example-paracetamol"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073664"/>
<display value="Tablet"/>
</coding>
</administrableDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000002152"/>
<display value="Tablet"/>
</coding>
</unitOfPresentation>
<producedFrom>🔗
<reference
value="ManufacturedItemDefinition/mid-epi-type2-example-paracetamol"/>
</producedFrom>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="shape"/>
<display value="Shape"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073670"/>
<display value="Round"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="color"/>
<display value="Color"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073586"/>
<display value="White"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="flavor"/>
<display value="Flavor"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000000000"/>
<display value="None"/>
</coding>
</valueCodeableConcept>
</property>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="image"/>
<display value="Image"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000000000"/>
<display value="Tablet Image"/>
</coding>
</valueCodeableConcept>
</property>
<routeOfAdministration>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073619"/>
<display value="Oral use"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-paracetamol-active"/>
<resource>
<Ingredient>
<id value="ingredient-epi-type2-example-paracetamol-active"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-epi-type2-example-paracetamol-active"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-epi-type2-example-paracetamol-active</b></p><a name="ingredient-epi-type2-example-paracetamol-active"> </a><a name="hcingredient-epi-type2-example-paracetamol-active"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Ingredient-uv-epi.html">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/ingredient-epi-type2-example-paracetamol-active</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-mid-epi-type2-example-paracetamol.html">ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072072}">Active</span></p><p><b>function</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000136065}">API</span></p><p><b>group</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000136179}">Chemical</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/smswi 100000000000}">Paracetamol</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td></tr><tr><td style="display: none">*</td><td>500 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM codemg = 'mg')</span>/1 tablet<span style="background: LightGoldenRodYellow"> (Details: EDQM Standard Terms code10219000 = 'Tablet')</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://example.org/identifier"/>
<value value="ingredient-epi-type2-example-paracetamol-active"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-epi-type2-example-paracetamol"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072072"/>
<display value="Active"/>
</coding>
</role>
<function>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000136065"/>
<display value="API"/>
</coding>
</function>
<group>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000136179"/>
<display value="Chemical"/>
</coding>
</group>
<substance>
<code>
<concept>
<coding>
<system value="https://spor.ema.europa.eu/smswi"/>
<code value="100000000000"/>
<display value="Paracetamol"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="500"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="tablet"/>
<system value="http://standardterms.edqm.eu"/>
<code value="10219000"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicationKnowledge/medication-knowledge-epi-type3-example"/>
<resource>
<MedicationKnowledge>
<id value="medication-knowledge-epi-type3-example"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicationKnowledge_medication-knowledge-epi-type3-example"> </a><p class="res-header-id"><b>Generated Narrative: MedicationKnowledge medication-knowledge-epi-type3-example</b></p><a name="medication-knowledge-epi-type3-example"> </a><a name="hcmedication-knowledge-epi-type3-example"> </a><p><b>status</b>: Active</p><blockquote><p><b>indicationGuideline</b></p><h3>Indications</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://snomed.info/sct 386661006}">Fever</span></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://snomed.info/sct 22253000}">Pain</span></td></tr></table><blockquote><p><b>dosingGuideline</b></p><p><b>treatmentIntent</b>: <span title="Codes:{http://snomed.info/sct 384812002}">Pain relief</span></p><blockquote><p><b>dosage</b></p><p><b>type</b>: <span title="Codes:">Initial Treatment (Week 1)</span></p><blockquote><p><b>dosage</b></p><p><b>sequence</b>: 1</p><p><b>text</b>: Take 1 tablet twice daily for the first week</p><p><b>timing</b>: 2 per 1 day</p><h3>DoseAndRates</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Dose[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/dose-rate-type ordered}">Ordered</span></td><td>1 tablet<span style="background: LightGoldenRodYellow"> (Details: EDQM Standard Terms code10219000 = 'Tablet')</span></td></tr></table></blockquote></blockquote><blockquote><p><b>dosage</b></p><p><b>type</b>: <span title="Codes:">Maintenance Treatment (Weeks 2-4)</span></p><blockquote><p><b>dosage</b></p><p><b>sequence</b>: 2</p><p><b>text</b>: Take 1 tablet once daily for three more weeks</p><p><b>timing</b>: Once per 1 day</p><h3>DoseAndRates</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Dose[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/dose-rate-type ordered}">Ordered</span></td><td>1 tablet<span style="background: LightGoldenRodYellow"> (Details: EDQM Standard Terms code10219000 = 'Tablet')</span></td></tr></table></blockquote></blockquote></blockquote></blockquote></div>
</text>
<status value="active"/>
<indicationGuideline>
<indication>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="386661006"/>
<display value="Fever"/>
</coding>
</concept>
</indication>
<indication>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="22253000"/>
<display value="Pain"/>
</coding>
</concept>
</indication>
<dosingGuideline>
<treatmentIntent>
<coding>
<system value="http://snomed.info/sct"/>
<code value="384812002"/>
<display value="To relieve pain"/>
</coding>
<text value="Pain relief"/>
</treatmentIntent>
<dosage>
<type>
<text value="Initial Treatment (Week 1)"/>
</type>
<dosage>
<sequence value="1"/>
<text value="Take 1 tablet twice daily for the first week"/>
<timing>
<repeat>
<boundsDuration>
<value value="7"/>
<unit value="days"/>
<system value="http://unitsofmeasure.org"/>
<code value="d"/>
</boundsDuration>
<frequency value="2"/>
<period value="1"/>
<periodUnit value="d"/>
</repeat>
</timing>
<doseAndRate>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/dose-rate-type"/>
<code value="ordered"/>
<display value="Ordered"/>
</coding>
</type>
<doseQuantity>
<value value="1"/>
<unit value="tablet"/>
<system value="http://standardterms.edqm.eu"/>
<code value="10219000"/>
</doseQuantity>
</doseAndRate>
</dosage>
</dosage>
<dosage>
<type>
<text value="Maintenance Treatment (Weeks 2-4)"/>
</type>
<dosage>
<sequence value="2"/>
<text value="Take 1 tablet once daily for three more weeks"/>
<timing>
<repeat>
<boundsDuration>
<value value="21"/>
<unit value="days"/>
<system value="http://unitsofmeasure.org"/>
<code value="d"/>
</boundsDuration>
<frequency value="1"/>
<period value="1"/>
<periodUnit value="d"/>
</repeat>
</timing>
<doseAndRate>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/dose-rate-type"/>
<code value="ordered"/>
<display value="Ordered"/>
</coding>
</type>
<doseQuantity>
<value value="1"/>
<unit value="tablet"/>
<system value="http://standardterms.edqm.eu"/>
<code value="10219000"/>
</doseQuantity>
</doseAndRate>
</dosage>
</dosage>
</dosingGuideline>
</indicationGuideline>
</MedicationKnowledge>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-indication-1"/>
<resource>
<ClinicalUseDefinition>
<id value="cud-indication-1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-indication-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_cud-indication-1"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition cud-indication-1</b></p><a name="cud-indication-1"> </a><a name="hccud-indication-1"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ClinicalUseDefinition-indication-uv-epi.html">ClinicalUseDefinition Indication (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/cud-indication-1</p><p><b>type</b>: Indication</p><p><b>category</b>: <span title="Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig indication}">Indication</span></p><p><b>subject</b>: <a href="Bundle-bundle-epi-type3-example-wonderdrug.html#http-//hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active</a></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://snomed.info/sct 386661006}">Fever</span></td></tr></table></blockquote><p><b>population</b>: Adults</p></div>
</text>
<identifier>
<system value="http://example.org/identifier"/>
<value value="cud-indication-1"/>
</identifier>
<type value="indication"/>
<category>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="indication"/>
<display value="Indication"/>
</coding>
</category>
<subject>🔗
<reference
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug"/>
</subject>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="386661006"/>
<display value="Fever"/>
</coding>
</concept>
</diseaseSymptomProcedure>
</indication>
<population>
<display value="Adults"/>
</population>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-indication-2"/>
<resource>
<ClinicalUseDefinition>
<id value="cud-indication-2"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-indication-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_cud-indication-2"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition cud-indication-2</b></p><a name="cud-indication-2"> </a><a name="hccud-indication-2"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ClinicalUseDefinition-indication-uv-epi.html">ClinicalUseDefinition Indication (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/cud-indication-2</p><p><b>type</b>: Indication</p><p><b>category</b>: <span title="Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig indication}">Indication</span></p><p><b>subject</b>: <a href="Bundle-bundle-epi-type3-example-wonderdrug.html#http-//hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active</a></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://snomed.info/sct 22253000}">Pain</span></td></tr></table></blockquote><p><b>population</b>: Adults</p></div>
</text>
<identifier>
<system value="http://example.org/identifier"/>
<value value="cud-indication-2"/>
</identifier>
<type value="indication"/>
<category>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="indication"/>
<display value="Indication"/>
</coding>
</category>
<subject>🔗
<reference
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug"/>
</subject>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="22253000"/>
<display value="Pain"/>
</coding>
</concept>
</diseaseSymptomProcedure>
</indication>
<population>
<display value="Adults"/>
</population>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-contraindication-1"/>
<resource>
<ClinicalUseDefinition>
<id value="cud-contraindication-1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-contraindication-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_cud-contraindication-1"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition cud-contraindication-1</b></p><a name="cud-contraindication-1"> </a><a name="hccud-contraindication-1"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ClinicalUseDefinition-contraindication-uv-epi.html">ClinicalUseDefinition Contraindication (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/cud-contraindication-1</p><p><b>type</b>: Contraindication</p><p><b>category</b>: <span title="Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig contraindication}">Contraindication</span></p><p><b>subject</b>: <a href="Bundle-bundle-epi-type3-example-wonderdrug.html#http-//hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active</a></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><blockquote><p><b>contraindication</b></p><h3>DiseaseSymptomProcedures</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://snomed.info/sct 197270009}">Acute hepatic failure</span></td></tr></table></blockquote><p><b>population</b>: Adults</p></div>
</text>
<identifier>
<system value="http://example.org/identifier"/>
<value value="cud-contraindication-1"/>
</identifier>
<type value="contraindication"/>
<category>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="contraindication"/>
<display value="Contraindication"/>
</coding>
</category>
<subject>🔗
<reference
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug"/>
</subject>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<contraindication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="197270009"/>
<display value="Acute hepatic failure"/>
</coding>
</concept>
</diseaseSymptomProcedure>
</contraindication>
<population>
<display value="Adults"/>
</population>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-contraindication-2"/>
<resource>
<ClinicalUseDefinition>
<id value="cud-contraindication-2"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-contraindication-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_cud-contraindication-2"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition cud-contraindication-2</b></p><a name="cud-contraindication-2"> </a><a name="hccud-contraindication-2"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ClinicalUseDefinition-contraindication-uv-epi.html">ClinicalUseDefinition Contraindication (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/cud-contraindication-2</p><p><b>type</b>: Contraindication</p><p><b>category</b>: <span title="Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig contraindication}">Contraindication</span></p><p><b>subject</b>: <a href="Bundle-bundle-epi-type3-example-wonderdrug.html#http-//hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active</a></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><blockquote><p><b>contraindication</b></p><blockquote><p><b>otherTherapy</b></p><p><b>relationshipType</b>: <span title="Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/benefit-and-risk-relationship contraindicated-only-with}">Only contraindicated with</span></p><h3>Treatments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://snomed.info/sct 763158003}">Medicinal product (product)</span></td></tr></table></blockquote></blockquote><p><b>population</b>: Adults</p></div>
</text>
<identifier>
<system value="http://example.org/identifier"/>
<value value="cud-contraindication-2"/>
</identifier>
<type value="contraindication"/>
<category>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="contraindication"/>
<display value="Contraindication"/>
</coding>
</category>
<subject>🔗
<reference
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug"/>
</subject>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<contraindication>
<otherTherapy>
<relationshipType>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/benefit-and-risk-relationship"/>
<code value="contraindicated-only-with"/>
<display value="Only contraindicated with"/>
</coding>
</relationshipType>
<treatment>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="763158003"/>
<display value="Medicinal product (product)"/>
</coding>
</concept>
</treatment>
</otherTherapy>
</contraindication>
<population>
<display value="Adults"/>
</population>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-interaction-1"/>
<resource>
<ClinicalUseDefinition>
<id value="cud-interaction-1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-interaction-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_cud-interaction-1"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition cud-interaction-1</b></p><a name="cud-interaction-1"> </a><a name="hccud-interaction-1"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ClinicalUseDefinition-interaction-uv-epi.html">ClinicalUseDefinition Interaction (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/cud-interaction-1</p><p><b>type</b>: Interaction</p><p><b>category</b>: <span title="Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig interaction}">Interaction</span></p><p><b>subject</b>: <a href="Bundle-bundle-epi-type3-example-wonderdrug.html#http-//hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active</a></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><blockquote><p><b>interaction</b></p><h3>Interactants</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Item[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://snomed.info/sct 372756006}">Warfarin</span></td></tr></table><h3>Effects</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://snomed.info/sct 404684003}">Clinical finding (finding)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://example.org/identifier"/>
<value value="cud-interaction-1"/>
</identifier>
<type value="interaction"/>
<category>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="interaction"/>
<display value="Interaction"/>
</coding>
</category>
<subject>🔗
<reference
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug"/>
</subject>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<interaction>
<interactant>
<itemCodeableConcept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="372756006"/>
<display value="Warfarin"/>
</coding>
</itemCodeableConcept>
</interactant>
<effect>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="404684003"/>
<display value="Clinical finding (finding)"/>
</coding>
</concept>
</effect>
</interaction>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-interaction-2"/>
<resource>
<ClinicalUseDefinition>
<id value="cud-interaction-2"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-interaction-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_cud-interaction-2"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition cud-interaction-2</b></p><a name="cud-interaction-2"> </a><a name="hccud-interaction-2"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ClinicalUseDefinition-interaction-uv-epi.html">ClinicalUseDefinition Interaction (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/cud-interaction-2</p><p><b>type</b>: Interaction</p><p><b>category</b>: <span title="Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig interaction}">Interaction</span></p><p><b>subject</b>: <a href="Bundle-bundle-epi-type3-example-wonderdrug.html#http-//hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active</a></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><blockquote><p><b>interaction</b></p><h3>Interactants</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Item[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://www.nlm.nih.gov/research/umls/rxnorm 11289}">Warfarin</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://example.org/identifier"/>
<value value="cud-interaction-2"/>
</identifier>
<type value="interaction"/>
<category>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="interaction"/>
<display value="Interaction"/>
</coding>
</category>
<subject>🔗
<reference
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug"/>
</subject>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<interaction>
<interactant>
<itemCodeableConcept>
<coding>
<system value="http://www.nlm.nih.gov/research/umls/rxnorm"/>
<code value="11289"/>
<display value="Warfarin"/>
</coding>
</itemCodeableConcept>
</interactant>
</interaction>
</ClinicalUseDefinition>
</resource>
</entry>
</Bundle>
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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