Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/joofio/test-epi-composition/ and changes regularly. See the Directory of published versions
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "bundlepackageleaflet-en-8ff5d67e0b7de732bda1082340f24212"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:identifier [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "None" ] ] ; # fhir:type [ fhir:v "document"] ; # fhir:timestamp [ fhir:v "2023-06-27T10:09:22Z"^^xsd:dateTime] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "Composition/composition-en-8ff5d67e0b7de732bda1082340f24212"^^xsd:anyURI ] ; ( fhir:resource <Composition/composition-en-8ff5d67e0b7de732bda1082340f24212> ) ] [ fhir:fullUrl [ fhir:v "MedicinalProductDefinition/mp8ff5d67e0b7de732bda1082340f24212"^^xsd:anyURI ] ; ( fhir:resource <MedicinalProductDefinition/mp8ff5d67e0b7de732bda1082340f24212> ) ] ) . # <Composition/composition-en-8ff5d67e0b7de732bda1082340f24212> a fhir:Composition ; fhir:id [ fhir:v "composition-en-8ff5d67e0b7de732bda1082340f24212"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><a name=\"Composition_composition-en-8ff5d67e0b7de732bda1082340f24212\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-8ff5d67e0b7de732bda1082340f24212</b></p><a name=\"composition-en-8ff5d67e0b7de732bda1082340f24212\"> </a><a name=\"hccomposition-en-8ff5d67e0b7de732bda1082340f24212\"> </a><a name=\"composition-en-8ff5d67e0b7de732bda1082340f24212-en-US\"> </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\">Language: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/23/1718/001</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi/ 100000155538}\">Package Leaflet</span></p><p><b>category</b>: <span title=\"Codes:{http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs R}\">Raw</span></p><p><b>date</b>: 2022-02-16 13:28:17+0000</p><p><b>author</b>: <a href=\"Organization-mah-ema.html\">Organization ACME industry</a></p><p><b>title</b>: TEST PURPOSES ONLY - sotyktu</p><h3>Attesters</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/composition-attestation-mode official}\">Official</span></td><td>2022-02-16 13:28:17+0000</td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU/1/23/1718/001" ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "Package Leaflet" ] ] ; # fhir:category ( [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs"^^xsd:anyURI ] ; fhir:code [ fhir:v "R" ] ; fhir:display [ fhir:v "Raw" ] ] ) ] ) ; # fhir:subject ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/mp8ff5d67e0b7de732bda1082340f24212" ] ] ) ; # fhir:date [ fhir:v "2022-02-16T13:28:17Z"^^xsd:dateTime] ; # fhir:author ( [ fhir:reference [ fhir:v "Organization/mah-ema" ] ] ) ; # fhir:title [ fhir:v "TEST PURPOSES ONLY - sotyktu"] ; # fhir:attester ( [ fhir:mode [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/composition-attestation-mode"^^xsd:anyURI ] ; fhir:code [ fhir:v "official" ] ] ) ] ; fhir:time [ fhir:v "2022-02-16T13:28:17Z"^^xsd:dateTime ] ] ) ; # fhir:section ( [ fhir:title [ fhir:v "B. Package Leaflet" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "B. Package Leaflet" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>" ] ; fhir:emptyReason [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ; fhir:code [ fhir:v "unavailable" ] ] ) ] ; ( fhir:section [ fhir:title [ fhir:v "Package leaflet: Information for the user" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "Package leaflet: Information for the user" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "What is in this leaflet" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "What is in this leaflet" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What is in this leaflet</p><ol type=\"1\"><li>What SOTYKTU is and what it is used for</li><li>What you need to know before you take SOTYKTU</li><li>How to take SOTYKTU</li><li>Possible side effects</li><li>How to store SOTYKTU</li><li>Contents of the pack and other information</li></ol></div>" ] ] [ fhir:title [ fhir:v "1. What sotyktu is and what it is used for" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "1. What sotyktu is and what it is used for" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What SOTYKTU is SOTYKTU contains the active substance deucravacitinib, which belongs to a group of medicines called tyrosine kinase 2 (TYK2) inhibitors that help to reduce inflammation associated with psoriasis.</p><p>What SOTYKTU is used for SOTYKTU is used to treat adults with moderate to severe plaque psoriasis , an inflammatory condition affecting the skin, which can cause red, scaly, thick, itchy, painful patches on your skin and can also affect your scalp and nails, hands, and feet.</p><p>How SOTYKTU works SOTYKTU works by selectively blocking the activity of an enzyme called TYK2 (tyrosine kinase 2) which is involved in the process of inflammation. By reducing the activity of this enzyme, SOTYKTU can help to control the inflammation associated with plaque psoriasis and thereby reduce the signs (skin dryness, cracking, scaling, shedding, or flaking, redness and bleeding) and can therefore help to reduce symptoms such as itching, pain, burning, stinging, and skin tightness of this condition.</p><p>SOTYKTU has also been shown to improve the quality of life in patients with psoriasis. This means that the impact of your condition on daily activities, relationships and other factors should be less than it was before.</p></div>" ] ] [ fhir:title [ fhir:v "2. What you need to know before you take sotyktu" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "2. What you need to know before you take sotyktu" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not take SOTYKTU</p><ul><li>if you are allergic to deucravacitinib or any of the other ingredients of this medicine (listed in section 6).</li><li>if you have an infection, including active tuberculosis (TB) which your doctor thinks is important.</li></ul><p>Warnings and precautions Talk to your doctor or pharmacist before taking SOTYKTU:</p><ul><li>if you currently have an infection that does not go away or that keeps coming back</li><li>if you have or have ever had tuberculosis (TB)</li><li>if you have cancer, because your doctor will have to decide if you can still be given SOTYKTU</li><li>if you have heart problems or medical conditions that make you more likely to develop heart disease - it is not clear if SOTYKTU increases the risk of heart disease</li><li>if you have had or are at risk of blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism). Tell your doctor if you get a painful swollen leg, chest pain, or shortness of breath as these can be signs of blood clots in the veins. It is not clear if SOTYKTU increases the risk of blood clots</li><li>if you have recently had or plan to have a vaccination.</li></ul><p>If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using SOTYKTU.</p><p>Children and adolescents SOTYKTU is not recommended for children and adolescents under 18 years of age because it has not been evaluated in this age group.</p><p>Other medicines and SOTYKTU Tell your doctor or pharmacist:</p><ul><li>if you are taking, have recently taken or might take any other medicines</li><li>if you recently had or plan to have a vaccination. You should not be given certain types of vaccines (live vaccines) while using SOTYKTU.</li></ul><p>Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. This is because it is not known how this medicine will affect the baby.</p><p>Driving and using machines SOTYKTU is not expected to affect your ability to drive or use machines.</p><p>SOTYKTU contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.</p><p>SOTYKTU contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free .</p></div>" ] ] [ fhir:title [ fhir:v "3. How to take sotyktu" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "3. How to take sotyktu" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.</p><p>The recommended dose is 6 mg taken every day. The tablet should be swallowed whole and can be taken either with or without food. Do not crush, cut, or chew the tablets.</p><p>Your doctor will decide for how long you need to use SOTYKTU.</p><p>If your condition has not improved after six months of treatment, talk to your doctor.</p><p>If you take more SOTYKTU than you should If you have taken more SOTYKTU than you should, talk to your doctor as soon as possible. You may get some of the side effects listed in section 4. If you forget to take SOTYKTU If you forgot to take SOTYKTU, just take the normal dose the next day. Do not take a double dose to make up for a forgotten tablet.</p><p>If you stop taking SOTYKTU Do not stop taking SOTYKTU without talking to your doctor first. If you stop treatment, symptoms of psoriasis may come back.</p><p>If you have any further questions on the use of this medicine, ask your doctor or pharmacist.</p></div>" ] ] [ fhir:title [ fhir:v "4. Possible side effects" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "4. Possible side effects" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Like all medicines, this medicine can cause side effects, although not everybody gets them.</p><p>Very common (may affect more than 1 in 10 people)</p><ul><li>upper respiratory tract (nose and throat) infections with symptoms such as sore throat and stuffy nose</li></ul><p>Common (may affect up to 1 in 10 people)</p><ul><li>viral infection of the mouth (such as cold sores)</li><li>an increase in the level of an enzyme in your blood called creatine phosphokinase (CPK)</li><li>sores in mouth</li><li>acne-like rashes</li><li>inflammation of hair follicles</li></ul><p>Uncommon (may affect up to 1 in 100 people)</p><ul><li>shingles (herpes zoster)</li></ul><p>Reporting of side effects If you get any side effects, talk to your doctor, nurse, or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.</p></div>" ] ] [ fhir:title [ fhir:v "5. How to store sotyktu" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "5. How to store sotyktu" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Keep this medicine out of the sight and reach of children.</p><p>Do not use this medicine after the expiry date which is stated on the blister and carton after EXP . The expiry date refers to the last day of that month.</p><p>This medicine does not require any special storage conditions.</p><p>Do not use this medicine if you notice the tablets are damaged or there are signs of tampering with the medicine packaging.</p><p>Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.</p></div>" ] ] [ fhir:title [ fhir:v "6. Contents of the pack and other information" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "6. Contents of the pack and other information" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What SOTYKTU contains The active substance is deucravacitinib. Each film-coated tablet contains 6 mg of deucravacitinib.</p><p>The other ingredients are</p><ul><li>tablet core: hypromellose acetate succinate, anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, colloidal hydrated silica and magnesium stearate.</li><li>film-coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide red (E172) and iron oxide yellow (E172).</li></ul><p>What SOTYKTU looks like and contents of the pack SOTYKTU is a pink, round, biconvex, film-coated tablet printed with BMS 895 and 6 mg on one side, in two lines, plain on the other side.</p><p>The film-coated tablets are provided in calendar or non-calendar blisters containing 7 or 14 tablets. Each pack contains 7, 14, 28 or 84 film-coated tablets.</p><p>Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Plaza Blanchardstown Corporate Park 2 Dublin 15, D15 TIreland</p><p>Manufacturer Swords Laboratories Unlimited Company T/A Bristol-Myers Squibb Pharmaceutical Operations External Manufacturing Plaza Blanchardstown Corporate Park 2 Dublin 15, D15 TIreland</p><p>For any information about this medicine, please contact the local representative of the Marketing<br/>Authorisation Holder:</p><p>Belgique/Belgi /Belgien N.V. Bristol-Myers Squibb Belgium S.A. T l/Tel: + 32 2 352 76 <a href=\"mailto:medicalinfo.belgium@bms.com\">medicalinfo.belgium@bms.com</a></p><p>Lietuva Swixx Biopharma UAB Tel: + 370 52 <a href=\"mailto:369medinfo.lithuania@swixxbiopharma.com\">369medinfo.lithuania@swixxbiopharma.com</a></p><p>Swixx Biopharma EOOD Te .: + 359 2 4942 <a href=\"mailto:medinfo.bulgaria@swixxbiopharma.com\">medinfo.bulgaria@swixxbiopharma.com</a></p><p>Luxembourg/Luxemburg N.V. Bristol-Myers Squibb Belgium S.A. T l/Tel: + 32 2 352 76 <a href=\"mailto:medicalinfo.belgium@bms.com\">medicalinfo.belgium@bms.com</a></p><p>esk republika Bristol-Myers Squibb spol. s r.o. Tel: + 420 221 016 <a href=\"mailto:medinfo.czech@bms.com\">medinfo.czech@bms.com</a></p><p>Magyarorsz g Bristol-Myers Squibb Kft. Tel.: + 36 1 301 <a href=\"mailto:9Medinfo.hungary@bms.com\">9Medinfo.hungary@bms.com</a></p><p>Danmark Bristol-Myers Squibb Denmark Tlf: + 45 45 93 05 <a href=\"mailto:medinfo.denmark@bms.com\">medinfo.denmark@bms.com</a></p><p>Malta A.M. Mangion Ltd Tel: + 356 <a href=\"mailto:23976pv@ammangion.com\">23976pv@ammangion.com</a></p><p>Deutschland Bristol-Myers Squibb GmbH & Co. KGaA Tel: 0800 0752002 (+ 49 89 121 42 350) <a href=\"mailto:medwiss.info@bms.com\">medwiss.info@bms.com</a></p><p>Nederland Bristol-Myers Squibb B.V. Tel: + 31 (0)30 300 <a href=\"mailto:2medischeafdeling@bms.com\">2medischeafdeling@bms.com</a></p><p>Eesti Swixx Biopharma O<br/>Tel: + 372 640 <a href=\"mailto:1medinfo.estonia@swixxbiopharma.com\">1medinfo.estonia@swixxbiopharma.com</a></p><p>Norge Bristol-Myers Squibb Norway Ltd. Tlf: + 47 67 55 53 <a href=\"mailto:medinfo.norway@bms.com\">medinfo.norway@bms.com</a></p><p>Bristol-Myers Squibb A.E. : + 30 210 <a href=\"mailto:6074medinfo.greece@bms.com\">6074medinfo.greece@bms.com</a></p><p>sterreich Bristol-Myers Squibb GesmbH Tel: + 43 1 60 14 <a href=\"mailto:medinfo.austria@bms.com\">medinfo.austria@bms.com</a></p><p>Espa a Bristol-Myers Squibb, S.A. Tel: + 34 91 456 53 <a href=\"mailto:informacion.medica@bms.com\">informacion.medica@bms.com</a></p><p>Polska Bristol-Myers Squibb Polska Sp. z o.o. Tel.: + 48 22 <a href=\"mailto:2606informacja.medyczna@bms.com\">2606informacja.medyczna@bms.com</a></p><p>France Bristol-Myers Squibb SAS T l: + 33 (0)1 58 83 84 <a href=\"mailto:infomed@bms.com\">infomed@bms.com</a></p><p>Portugal Bristol-Myers Squibb Farmac utica Portuguesa, S.A. Tel: + 351 21 440 70 <a href=\"mailto:portugal.medinfo@bms.com\">portugal.medinfo@bms.com</a></p><p>Hrvatska Swixx Biopharma d.o.o. Tel: + 385 1 2078 <a href=\"mailto:medinfo.croatia@swixxbiopharma.com\">medinfo.croatia@swixxbiopharma.com</a></p><p>Rom nia Bristol-Myers Squibb Marketing Services S.R.L. Tel: + 40 (0)21 272 16 <a href=\"mailto:medinfo.romania@bms.com\">medinfo.romania@bms.com</a></p><p>Ireland Bristol-Myers Squibb Pharmaceuticals uc Tel: 1 800 749 749 (+ 353 (0)1 483 3625) <a href=\"mailto:medical.information@bms.com\">medical.information@bms.com</a></p><p>Slovenija Swixx Biopharma d.o.o. Tel: + 386 1 2355 <a href=\"mailto:medinfo.slovenia@swixxbiopharma.com\">medinfo.slovenia@swixxbiopharma.com</a></p><p>sland Vistor hf. S mi: + 354 535 <a href=\"mailto:7vistor@vistor.is\">7vistor@vistor.is</a> <a href=\"mailto:medical.information@bms.com\">medical.information@bms.com</a></p><p>Slovensk republika Swixx Biopharma s.r.o. Tel: + 421 2 20833 <a href=\"mailto:medinfo.slovakia@swixxbiopharma.com\">medinfo.slovakia@swixxbiopharma.com</a><br/>Italia Bristol-Myers Squibb S.r.l. Tel: + 39 06 50 39 <a href=\"mailto:medicalinformation.italia@bms.com\">medicalinformation.italia@bms.com</a></p><p>Suomi/Finland Oy Bristol-Myers Squibb (Finland) Ab Puh/Tel: + 358 9 251 21 <a href=\"mailto:medinfo.finland@bms.com\">medinfo.finland@bms.com</a></p><p>Bristol-Myers Squibb A.E. : 800 92666 (+ 30 210 6074300) <a href=\"mailto:medinfo.greece@bms.com\">medinfo.greece@bms.com</a></p><p>Sverige Bristol-Myers Squibb Aktiebolag Tel: + 46 8 704 71 <a href=\"mailto:medinfo.sweden@bms.com\">medinfo.sweden@bms.com</a></p><p>Latvija Swixx Biopharma SIA Tel: + 371 <a href=\"mailto:66164medinfo.latvia@swixxbiopharma.com\">66164medinfo.latvia@swixxbiopharma.com</a></p><p>United Kingdom (Northern Ireland) Bristol-Myers Squibb Pharmaceutical Limited Tel: +44 (0)800 731 <a href=\"mailto:1medical.information@bms.com\">1medical.information@bms.com</a></p><p>This leaflet was last revised in</p><p>Other sources of information</p><p>Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>" ] ] ) ] ) . # <MedicinalProductDefinition/mp8ff5d67e0b7de732bda1082340f24212> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "mp8ff5d67e0b7de732bda1082340f24212"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mp8ff5d67e0b7de732bda1082340f24212\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mp8ff5d67e0b7de732bda1082340f24212</b></p><a name=\"mp8ff5d67e0b7de732bda1082340f24212\"> </a><a name=\"hcmp8ff5d67e0b7de732bda1082340f24212\"> </a><a name=\"mp8ff5d67e0b7de732bda1082340f24212-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/23/1718/001</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}\">Medicinal Product</span></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><blockquote><p><b>name</b></p><p><b>productName</b>: SOTYKTU 6 mg film-coated tablets</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}\">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}\">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}\">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>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 EU}\">EU</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 EU}\">EU</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 en}\">en</span></td></tr></table></blockquote></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU/1/23/1718/001" ] ] ) ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "MedicinalProduct" ] ; fhir:display [ fhir:v "Medicinal Product" ] ] ) ] ; # fhir:domain [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-domain"^^xsd:anyURI ] ; fhir:code [ fhir:v "Human" ] ; fhir:display [ fhir:v "Human use" ] ] ) ] ; # fhir:status [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ; fhir:code [ fhir:v "active" ] ; fhir:display [ fhir:v "active" ] ] ) ] ; # fhir:legalStatusOfSupply [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000072084" ] ; fhir:display [ fhir:v "Medicinal product subject to medical prescription" ] ] ) ] ; # fhir:name ( [ fhir:productName [ fhir:v "SOTYKTU 6 mg film-coated tablets" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000001" ] ; fhir:display [ fhir:v "Full name" ] ] ) ] ; ( fhir:part [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000002" ] ; fhir:display [ fhir:v "Invented name part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000003" ] ; fhir:display [ fhir:v "Scientific name part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000004" ] ; fhir:display [ fhir:v "Strength part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000005" ] ; fhir:display [ fhir:v "Pharmaceutical dose form part" ] ] ) ] ] ) ; ( fhir:usage [ fhir:country [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "EU" ] ; fhir:display [ fhir:v "EU" ] ] ) ] ; fhir:jurisdiction [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "EU" ] ; fhir:display [ fhir:v "EU" ] ] ) ] ; fhir:language [ ( fhir:coding [ fhir:system [ fhir:v "urn:ietf:bcp:47"^^xsd:anyURI ] ; fhir:code [ fhir:v "en" ] ; fhir:display [ fhir:v "en" ] ] ) ] ] ) ] ) . #
IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.ghepi#0.1.0 based on FHIR 5.0.0. Generated 2024-10-14
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The Gravitate Health project has received funding from the IMI 2 Joint Undertaking under grant agreement No 945334.
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.
