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 |
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:Composition ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "composition-epi-type3-example-wonderdrug"] ; # fhir:meta [ fhir:versionId [ fhir:v "1" ] ; fhir:lastUpdated [ fhir:v "2023-10-27T10:00:00Z"^^xsd:dateTime ] ; ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>WonderDrug Summary of Product Characteristics</p></div>"^^rdf:XMLLiteral ] ] ; # fhir:contained ( [ a fhir:Binary ; fhir:id [ fhir:v "binaryImage-t3" ] ; fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/binary-epi"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/binary-epi> ] ) ] ; fhir:contentType [ fhir:v "image/png" ] ; fhir:data [ fhir:v "iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAQAAAC1HAwCAAAAC0lEQVR42mNkYAAAAAYAAjCB0C8AAAAASUVORK5CYII="^^xsd:base64Binary ] ] ) ; # fhir:identifier ( [ fhir:system [ fhir:v "http://example.org/identifier"^^xsd:anyURI ; fhir:l <http://example.org/identifier> ] ; fhir:value [ fhir:v "composition-epi-type3-example-wonderdrug" ] ] ) ; # fhir:version [ fhir:v "1.0"] ; # fhir:status [ fhir:v "final"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "100000155532" ] ; fhir:display [ fhir:v "Summary of Product Characteristics" ] ] ) ] ; # fhir:subject ( [ fhir:l <http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug> ; fhir:reference [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug" ] ] ) ; # fhir:date [ fhir:v "2023-10-27"^^xsd:date] ; # fhir:author ( [ fhir:l fhir:Organization/org-epi-type3-example-pharma ; fhir:reference [ fhir:v "Organization/org-epi-type3-example-pharma" ] ] ) ; # fhir:title [ fhir:v "WonderDrug 500 mg tablets - Summary of Product Characteristics"] ; # fhir:section ( [ fhir:id [ fhir:v "a5529da2-d8b6-416c-907a-2f6486a49264" ] ; fhir:title [ fhir:v "SUMMARY OF PRODUCT CHARACTERISTICS" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029791" ] ; fhir:display [ fhir:v "SUMMARY OF PRODUCT CHARACTERISTICS" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\">Summary of Product Characteristics for WonderDrug</div>"^^rdf:XMLLiteral ] ] ; ( fhir:section [ fhir:id [ fhir:v "9f516bb9-8648-4564-883d-885d6d3c8964" ] ; fhir:title [ fhir:v "1. NAME OF THE MEDICINAL PRODUCT" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029792" ] ; fhir:display [ fhir:v "1. NAME OF THE MEDICINAL PRODUCT" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>WonderDrug 500 mg tablets</p></div>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "9859f8c7-0e7c-4b23-a643-16c907e99041" ] ; fhir:title [ fhir:v "2. QUALITATIVE AND QUANTITATIVE COMPOSITION" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029793" ] ; fhir:display [ fhir:v "2. QUALITATIVE AND QUANTITATIVE COMPOSITION" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Each tablet contains 500 mg of paracetamol.</p></div>"^^rdf:XMLLiteral ] ] ; ( fhir:section [ fhir:id [ fhir:v "163ef829-7ba3-486f-85e7-2a0c8d6e03d9" ] ; fhir:title [ fhir:v "2.1 General description" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029794" ] ; fhir:display [ fhir:v "2.1 General description" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>White, round, biconvex tablets.</p></div>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "4adc7d65-1c20-4f6b-871a-8f412de5d2a4" ] ; fhir:title [ fhir:v "2.2 Qualitative and quantitative composition" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029795" ] ; fhir:display [ fhir:v "2.2 Qualitative and quantitative composition" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Each tablet contains 500 mg paracetamol.</p></div>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "58eac29a-da40-491a-a068-09f622fbe455" ] ; fhir:title [ fhir:v "Excipient(s) with known effect" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029796" ] ; fhir:display [ fhir:v "Excipient(s) with known effect" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ] ) ] [ fhir:id [ fhir:v "c29ca0cb-6b4b-40b6-9362-804a2d42cd2d" ] ; fhir:title [ fhir:v "3. PHARMACEUTICAL FORM" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029797" ] ; fhir:display [ fhir:v "3. PHARMACEUTICAL FORM" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Tablet. White, round, biconvex tablets.</p></div>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "c36bb7fe-be38-4acc-ad4b-9dd188752ca8" ] ; fhir:title [ fhir:v "4. CLINICAL PARTICULARS" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029798" ] ; fhir:display [ fhir:v "4. CLINICAL PARTICULARS" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Clinical information about WonderDrug.</p></div>"^^rdf:XMLLiteral ] ] ; ( fhir:section [ fhir:id [ fhir:v "339c6a45-06ea-48d7-9eef-ca80a6c284d5" ] ; fhir:title [ fhir:v "4.1 Therapeutic indications" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029799" ] ; fhir:display [ fhir:v "4.1 Therapeutic indications" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "efd69da5-2510-445d-a59d-261632a92cec" ] ; fhir:title [ fhir:v "4.2 Posology and method of administration" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029800" ] ; fhir:display [ fhir:v "4.2 Posology and method of administration" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "477becff-ccc3-4f82-ac9b-d91a8ba4ace3" ] ; fhir:title [ fhir:v "4.3 Contraindications" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029805" ] ; fhir:display [ fhir:v "4.3 Contraindications" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Hypersensitivity to paracetamol or any of the excipients.</p></div>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "1878af14-22b3-4da4-aea8-0bfad72e101e" ] ; fhir:title [ fhir:v "4.4 Special warnings and precautions for use" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029806" ] ; fhir:display [ fhir:v "4.4 Special warnings and precautions for use" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Caution in patients with hepatic or renal impairment.</p></div>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "f3f877bf-322c-4823-bccc-d597f34e1168" ] ; fhir:title [ fhir:v "4.5 Interaction with other medicinal products and other forms of interaction" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029809" ] ; fhir:display [ fhir:v "4.5 Interaction with other medicinal products and other forms of interaction" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Anticoagulants: Enhanced effect of warfarin with prolonged use.</p></div>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "fd945cc2-f076-4f7e-bae0-b1dcd4279854" ] ; fhir:title [ fhir:v "4.6 Fertility, pregnancy and lactation" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029811" ] ; fhir:display [ fhir:v "4.6 Fertility, pregnancy and lactation" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "2ee553da-6e3d-4033-b351-16b624d57bdf" ] ; fhir:title [ fhir:v "4.7 Effects on ability to drive and use machines" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029815" ] ; fhir:display [ fhir:v "4.7 Effects on ability to drive and use machines" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>No known effect.</p></div>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "9bfa53f3-3404-459e-97ab-7e090ffc2812" ] ; fhir:title [ fhir:v "4.8 Undesirable effects" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029816" ] ; fhir:display [ fhir:v "4.8 Undesirable effects" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "0c762653-f91a-42c9-a5ae-5ec2d46eebf4" ] ; fhir:title [ fhir:v "4.9 Overdose" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029819" ] ; fhir:display [ fhir:v "4.9 Overdose" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Symptoms: Hepatic damage. Treatment: N-acetylcysteine.</p></div>"^^rdf:XMLLiteral ] ] ] ) ] [ fhir:id [ fhir:v "163e3b46-07f3-428f-9015-563df3345349" ] ; fhir:title [ fhir:v "5. PHARMACOLOGICAL PROPERTIES" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029821" ] ; fhir:display [ fhir:v "5. PHARMACOLOGICAL PROPERTIES" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Pharmacological properties of WonderDrug.</p></div>"^^rdf:XMLLiteral ] ] ; ( fhir:section [ fhir:id [ fhir:v "1aa4d0d4-2137-4cd8-ac7f-d6f910eebcfb" ] ; fhir:title [ fhir:v "5.1 Pharmacodynamic properties" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029822" ] ; fhir:display [ fhir:v "5.1 Pharmacodynamic properties" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Pharmacotherapeutic group: Analgesics, ATC code: N02BE01.</p></div>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "1fa3fb24-9319-4a6a-ab27-09e99372c584" ] ; fhir:title [ fhir:v "5.2 Pharmacokinetic properties" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029827" ] ; fhir:display [ fhir:v "5.2 Pharmacokinetic properties" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "1ddebeef-c6c6-4466-ba94-ded89fbfb7ab" ] ; fhir:title [ fhir:v "5.3 Preclinical safety data" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029834" ] ; fhir:display [ fhir:v "5.3 Preclinical safety data" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>No additional data of relevance.</p></div>"^^rdf:XMLLiteral ] ] ] ) ] [ fhir:id [ fhir:v "3354d395-ff4f-4cf2-9715-79d1572c5bd8" ] ; fhir:title [ fhir:v "6. PHARMACEUTICAL PARTICULARS" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029836" ] ; fhir:display [ fhir:v "6. PHARMACEUTICAL PARTICULARS" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Pharmaceutical particulars for WonderDrug.</p></div>"^^rdf:XMLLiteral ] ] ; ( fhir:section [ fhir:id [ fhir:v "1810edbd-e273-47ca-ac6d-95da39cbbf65" ] ; fhir:title [ fhir:v "6.1 List of excipients" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029837" ] ; fhir:display [ fhir:v "6.1 List of excipients" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Pregelatinised starch, maize starch, magnesium stearate.</p></div>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "92f549e6-2502-4a47-a0b2-d15481e5173b" ] ; fhir:title [ fhir:v "6.2 Incompatibilities" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029838" ] ; fhir:display [ fhir:v "6.2 Incompatibilities" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Not applicable.</p></div>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "29fb1695-4488-4e67-863b-ea8c0ce4d53d" ] ; fhir:title [ fhir:v "6.3 Shelf life" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029839" ] ; fhir:display [ fhir:v "6.3 Shelf life" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>3 years.</p></div>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "5d7ccb0a-ad90-4497-acbf-80d4f75dce83" ] ; fhir:title [ fhir:v "6.4 Special precautions for storage" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029840" ] ; fhir:display [ fhir:v "6.4 Special precautions for storage" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Store below 25°C.</p></div>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "c6299d8a-2062-40b4-bac1-d2076f43cdac" ] ; fhir:title [ fhir:v "6.5 Nature and contents of container" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029841" ] ; fhir:display [ fhir:v "6.5 Nature and contents of container" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "51d4458e-096d-4980-9d3a-6efd9e72185f" ] ; fhir:title [ fhir:v "6.6 Special precautions for disposal" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029842" ] ; fhir:display [ fhir:v "6.6 Special precautions for disposal" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>No special requirements.</p></div>"^^rdf:XMLLiteral ] ] ] ) ] [ fhir:id [ fhir:v "547a1ef0-952a-4dc0-8dc8-583445d2c680" ] ; fhir:title [ fhir:v "7. MARKETING AUTHORISATION HOLDER" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029844" ] ; fhir:display [ fhir:v "7. MARKETING AUTHORISATION HOLDER" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>WonderPharma Inc., 123 Pharma Way, Prague, Czech Republic</p></div>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "a717d6c2-dd85-47c9-9d0a-06185f400226" ] ; fhir:title [ fhir:v "8. MARKETING AUTHORISATION NUMBER(S)" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029845" ] ; fhir:display [ fhir:v "8. MARKETING AUTHORISATION NUMBER(S)" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>EU/1/23/1234/001</p></div>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "61b98f40-58f4-4602-97ad-0212e3a5bda2" ] ; fhir:title [ fhir:v "9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029846" ] ; fhir:display [ fhir:v "9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Date of first authorisation: 15 January 2020</p></div>"^^rdf:XMLLiteral ] ] ] [ fhir:id [ fhir:v "a6307678-ce1e-4bf2-b9a0-0b7a566887f7" ] ; fhir:title [ fhir:v "10. DATE OF REVISION OF THE TEXT" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ; fhir:l <https://spor.ema.europa.eu/rmswi> ] ; fhir:code [ fhir:v "200000029847" ] ; fhir:display [ fhir:v "10. DATE OF REVISION OF THE TEXT" ] ] ) ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>October 2023</p></div>"^^rdf:XMLLiteral ] ] ] ) ] ) . # <http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug> a fhir:Uv .
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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