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-684a35c27d00abaf233bd95a3f24554a"] ; # 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-684a35c27d00abaf233bd95a3f24554a"^^xsd:anyURI ] ; ( fhir:resource <Composition/composition-en-684a35c27d00abaf233bd95a3f24554a> ) ] [ fhir:fullUrl [ fhir:v "MedicinalProductDefinition/mp684a35c27d00abaf233bd95a3f24554a"^^xsd:anyURI ] ; ( fhir:resource <MedicinalProductDefinition/mp684a35c27d00abaf233bd95a3f24554a> ) ] ) . # <Composition/composition-en-684a35c27d00abaf233bd95a3f24554a> a fhir:Composition ; fhir:id [ fhir:v "composition-en-684a35c27d00abaf233bd95a3f24554a"] ; # 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-684a35c27d00abaf233bd95a3f24554a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-684a35c27d00abaf233bd95a3f24554a</b></p><a name=\"composition-en-684a35c27d00abaf233bd95a3f24554a\"> </a><a name=\"hccomposition-en-684a35c27d00abaf233bd95a3f24554a\"> </a><a name=\"composition-en-684a35c27d00abaf233bd95a3f24554a-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/1/16/1119/001</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 - zepatier</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/1/16/1119/001" ] ] ) ; # 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/mp684a35c27d00abaf233bd95a3f24554a" ] ] ) ; # 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 - zepatier"] ; # 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 ZEPATIER is and what it is used for</li><li>What you need to know before you take ZEPATIER</li><li>How to take ZEPATIER</li><li>Possible side effects</li><li>How to store ZEPATIER</li><li>Contents of the pack and other information</li></ol></div>" ] ] [ fhir:title [ fhir:v "1. What zepatier 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 zepatier 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 ZEPATIER is ZEPATIER is an antiviral medicine that contains the active substances elbasvir and grazoprevir. What ZEPATIER is used for ZEPATIER is used to treat long-term hepatitis C infection in adults and children aged 12 years and older who weigh at least 30 kilograms. How ZEPATIER works Hepatitis C is a virus that infects the liver. The active substances in the medicine work together by blocking two different proteins that the hepatitis C virus needs to grow and reproduce. This allows the infection to be permanently removed from the body. ZEPATIER is sometimes taken with another medicine, ribavirin. It is very important that you also read the leaflets for the other medicines that you will be taking with ZEPATIER. If you have any questions about your medicines, please ask your doctor or pharmacist.</p></div>" ] ] [ fhir:title [ fhir:v "2. What you need to know before you take zepatier" ] ; 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 zepatier" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not take ZEPATIER if:</p><p>you are allergic to elbasvir, grazoprevir or any of the other ingredients of this medicine (listed in section 6)</p><p>you have certain moderate or severe liver problems</p><p>you are taking any of the following medicines:* rifampicin, usually given for tuberculosis* HIV protease inhibitors such as atazanavir, darunavir, lopinavir, saquinavir, or tipranavir* efavirenz or etravirine for HIV* elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide for HIV* ciclosporin to stop organ transplant rejection or to treat serious inflammatory illnesses of eyes, kidney, joints or skin* bosentan for pulmonary arterial hypertension* carbamazepine or phenytoin, mainly used for epilepsy and seizures* modafinil to help people who cannot stay awake* St. John s wort (Hypericum perforatum, a herbal medicine) for depression or other problems If you are taking ZEPATIER with ribavirin, please make sure that you read the \"Do not take\" section of the ribavirin package leaflet. If you are unsure of any information in the package leaflet, please contact your doctor or pharmacist. Warnings and precautions Talk to your doctor or pharmacist before taking ZEPATIER if you:</p><p>have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely</p><p>have ever taken any medicine for hepatitis C</p><p>have any liver problems other than hepatitis C</p><p>have had a liver transplant</p><p>have diabetes. You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting ZEPATIER. Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like ZEPATIER.</p><p>have any other medical conditions. Blood tests Your doctor will test your blood before, during and after your treatment with ZEPATIER. This is so your doctor can:</p><p>decide if you should take ZEPATIER and for how long</p><p>decide what other medicines you should take with ZEPATIER and for how long</p><p>check for side effects</p><p>check if your treatment has worked and you are free of hepatitis C</p><p>check how your liver is working - tell your doctor straight away if you have any of the following signs of liver problems: loss of appetite; feeling or being sick; feeling tired or weak; yellowing of your skin or eyes; colour changes in your stool. Your doctor may want to test your blood to check how your liver is working if you develop any of these symptoms. Children ZEPATIER is not for use in children younger than 12 years of age. Other medicines and ZEPATIER Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and medicines obtained without a prescription. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. There are some medicines you must not take with ZEPATIER. See list under Do not take ZEPATIER if you are taking any of the following medicines. Tell your doctor or pharmacist if you take any of the following medicines:</p><p>oral ketoconazole for fungal infections</p><p>tacrolimus to prevent organ transplant rejection</p><p>dabigatran to prevent blood clots</p><p>rosuvastatin, atorvastatin, fluvastatin, simvastatin, or lovastatin, for lowering blood cholesterol</p><p>sunitinib to treat certain cancers</p><p>warfarin and other similar medicines called vitamin K antagonists used to thin the blood. Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot. Your liver function may improve with treatment of hepatitis C and therefore may affect other medications that are handled by the liver. Your doctor may need to closely monitor these other medicines you are taking and make adjustments during ZEPATIER therapy. Your doctor may have to change your medicines or change the dose of your medicines. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking ZEPATIER. Pregnancy and contraception The effects of ZEPATIER in pregnancy are not known. If you are pregnant, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. ZEPATIER with ribavirin</p><p>You must not become pregnant if you are taking ZEPATIER with ribavirin. Ribavirin can be very damaging to an unborn baby. This means you and your partner must take special precautions in sexual activity if there is any chance you or your partner could become pregnant.</p><p>You or your partner must use an effective method of contraception during treatment with ZEPATIER with ribavirin and for some time afterwards. Talk to your doctor about different contraception methods that are suitable for you.</p><p>If you or your partner becomes pregnant while taking ZEPATIER with ribavirin or in the months that follow, tell your doctor straight away.</p><p>It is very important that you read the information concerning pregnancy and contraception in the ribavirin package leaflet very carefully. It is important that both men and women read the information. Breast-feeding Talk to your doctor before taking ZEPATIER if you are breast-feeding. It is not known whether the two medicines in ZEPATIER pass into human breast milk. If you are taking ZEPATIER with ribavirin, make sure that you also read the Pregnancy and Breast-feeding sections of the package leaflet for this other medicine. Driving and using machines Do not drive or operate machines if you feel tired after taking your medicine. ZEPATIER contains lactose ZEPATIER contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine. ZEPATIER contains sodium This medicine contains 69.85 mg sodium (main component of cooking / table salt) in each tablet. This is equivalent to 3.5% of the recommended maximum daily dietary intake of sodium for an adult.</p></div>" ] ] [ fhir:title [ fhir:v "3. How to take zepatier" ] ; 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 zepatier" ] ] ; 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. Talk to your doctor or pharmacist before taking ZEPATIER if you have ever taken any medicines for hepatitis C or if you have any other medical condition. How much to take The recommended dose is one tablet once a day with or without food. Your doctor will tell you how many weeks you should take ZEPATIER for. Swallow the tablet whole with or without food. Do not chew, crush or split the tablet. Tell your doctor or pharmacist if you have problems swallowing tablets. If you take more ZEPATIER than you should If you take more ZEPATIER than you should, talk to a doctor straight away. Take the medicine pack with you so that you can show the doctor what you have taken. If you forget to take ZEPATIER It is important not to miss a dose of this medicine. If you do miss a dose, work out how long it is since you should have taken ZEPATIER:</p><p>If it has been less than 16 hours since you should have taken your dose, take the missed dose as soon as possible. Then take your next dose at your usual time.</p><p>If it has been more than 16 hours since you should have taken your dose, do not take the missed dose. Wait and take your next dose at your usual time.</p><p>Do not take a double dose (two doses together) to make up for a forgotten dose. Do not stop taking ZEPATIER Do not stop taking this medicine unless your doctor tells you to. It is very important that you complete the full course of treatment. This will give the medicine the best chance to treat your hepatitis C infection. 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. The following side effects may happen with this medicine: Tell your doctor or pharmacist if you notice any of the following side effects. Very common: may affect more than 1 in 10 people</p><p>feeling very tired (fatigue)</p><p>headache Common: may affect up to 1 in 10 people</p><p>feeling sick (nausea)</p><p>feeling weak or lack of energy (asthenia)</p><p>itching</p><p>diarrhoea</p><p>trouble sleeping (insomnia)</p><p>joint pain or painful, swollen joints</p><p>constipation</p><p>feeling dizzy</p><p>loss of appetite</p><p>feeling irritable</p><p>muscle aches</p><p>stomach pain</p><p>unusual hair loss or thinning</p><p>feeling nervous (anxiety)</p><p>depression</p><p>dry mouth</p><p>being sick (vomiting) Uncommon: may affect up to 1 in 100 people</p><p>abnormalities in laboratory tests of liver function Reporting of side effects If you get any side effects, talk to your doctor 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 zepatier" ] ; 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 zepatier" ] ] ; 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. Do not use the medicine after the expiry date which is stated on the carton and blister packaging after EXP . The expiry date refers to the last day of that month. This medicine does not require any special temperature storage conditions. Store in the original package until use to protect from moisture. 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 to 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 ZEPATIER contains</p><p>The active substances are: elbasvir and grazoprevir. Each film-coated tablet contains 50 mg elbasvir and 100 mg grazoprevir.</p><p>The other ingredients are:</p><p>Tablet core: Sodium laurilsulfate, vitamin E polyethylene glycol succinate, copovidone, hypromellose, microcrystalline cellulose, mannitol (E421), lactose monohydrate, croscarmellose sodium, sodium chloride, colloidal anhydrous silica, magnesium stearate.</p><p>Film-coating: Lactose monohydrate, hypromellose, titanium dioxide, triacetin, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172), carnauba wax. What ZEPATIER looks like and contents of the pack The film-coated tablets are beige, oval, debossed with 770 on one side and plain on the other. The tablet is 21 mm long and 10 mm wide. The tablets are packaged into a carton containing two cardboard cards, each cardboard card containing two 7-count aluminium blisters. Each carton contains a total of 28 tablets. Marketing Authorisation Holder Merck Sharp & Dohme B.V. Waarderweg 2031 BN Haarlem The Netherlands Manufacturer Organon Heist bv Industriepark 2220 Heist-op-den-Berg Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: BE/LU MSD Belgium T l/Tel: +32(0)<a href=\"mailto:27766dpoc_belux@merck.com\">27766dpoc_belux@merck.com</a> LT UAB Merck Sharp & Dohme Tel.: +370 5 278 02 <a href=\"mailto:msd_lietuva@merck.com\">msd_lietuva@merck.com</a> BG</p><p>.: +359 2 819 <a href=\"mailto:3info-msdbg@merck.com\">3info-msdbg@merck.com</a> HU MSD Pharma Hungary Kft. Tel.: +361 888 53 <a href=\"mailto:hungary_msd@merck.com\">hungary_msd@merck.com</a> CZ Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 <a href=\"mailto:dpoc_czechslovak@merck.com\">dpoc_czechslovak@merck.com</a> MT Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) <a href=\"mailto:malta_info@merck.com\">malta_info@merck.com</a> DK MSD Danmark ApS Tlf: +45 4482 <a href=\"mailto:4dkmail@merck.com\">4dkmail@merck.com</a> NL Merck Sharp & Dohme B.V. Tel: 0800 99 99 000 (+31 23 5153153) <a href=\"mailto:medicalinfo.nl@merck.com\">medicalinfo.nl@merck.com</a> DE MSD Sharp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0) <a href=\"mailto:e-mail@msd.de\">e-mail@msd.de</a> NO MSD (Norge) AS Tlf: +47 32 20 73 <a href=\"mailto:msdnorge@msd.no\">msdnorge@msd.no</a> EE Merck Sharp & Dohme O Tel.: +372 6144 <a href=\"mailto:msdeesti@merck.com\">msdeesti@merck.com</a> AT Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 <a href=\"mailto:dpoc_austria@merck.com\">dpoc_austria@merck.com</a> EL MSD . . . . . : + 30 210 98 97 <a href=\"mailto:dpoc_greece@merck.com\">dpoc_greece@merck.com</a> PL MSD Polska Sp.z o.o. Tel.: +48 22 549 51 <a href=\"mailto:msdpolska@merck.com\">msdpolska@merck.com</a> ES Merck Sharp & Dohme de Espa a, S.A. Tel: +34 91 321 06 <a href=\"mailto:msd_info@merck.com\">msd_info@merck.com</a> PT Merck Sharp & Dohme, Lda Tel: +351 21 446 <a href=\"mailto:5inform_pt@merck.com\">5inform_pt@merck.com</a> FR MSD France T l: + 33 (0) 1 80 46 40 RO Merck Sharp & Dohme Romania S.R.L. Tel: + 4021 529 29 <a href=\"mailto:msdromania@merck.com\">msdromania@merck.com</a> HR Merck Sharp & Dohme d.o.o. Tel: + 385 1 66 11 <a href=\"mailto:croatia_info@merck.com\">croatia_info@merck.com</a> SI Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 <a href=\"mailto:5204msd_slovenia@merck.com\">5204msd_slovenia@merck.com</a> IE Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 <a href=\"mailto:2998medinfo_ireland@merck.com\">2998medinfo_ireland@merck.com</a> SK Merck Sharp & Dohme, s. r. o. Tel.: +421 2 <a href=\"mailto:58282dpoc_czechslovak@merck.com\">58282dpoc_czechslovak@merck.com</a> IS Vistor hf. S mi: +354 535 7FI MSD Finland Oy Puh/Tel: +358 (0) 9 804 <a href=\"mailto:info@msd.fi\">info@msd.fi</a> IT MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) <a href=\"mailto:medicalinformation.it@msd.com\">medicalinformation.it@msd.com</a> SE Merck Sharp & Dohme (Sweden) AB Tel: +46 77 <a href=\"mailto:5700medicinskinfo@merck.com\">5700medicinskinfo@merck.com</a> CY Merck Sharp & Dohme Cyprus Limited : 800 00 673 (+357 22866700) <a href=\"mailto:cyprus_info@merck.com\">cyprus_info@merck.com</a> UK (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 <a href=\"mailto:2998medinfoNI@msd.com\">2998medinfoNI@msd.com</a> LV SIA Merck Sharp & Dohme Latvija Tel: +371 67364 <a href=\"mailto:msd_lv@merck.com\">msd_lv@merck.com</a> This leaflet was last revised in {MM/YYYY}. Detailed information on this medicine is available on the European Medicines Agency web site: <a href=\"http://www.ema.europa.eu\">http://www.ema.europa.eu</a>.</p></div>" ] ] ) ] ) . # <MedicinalProductDefinition/mp684a35c27d00abaf233bd95a3f24554a> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "mp684a35c27d00abaf233bd95a3f24554a"] ; # 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_mp684a35c27d00abaf233bd95a3f24554a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mp684a35c27d00abaf233bd95a3f24554a</b></p><a name=\"mp684a35c27d00abaf233bd95a3f24554a\"> </a><a name=\"hcmp684a35c27d00abaf233bd95a3f24554a\"> </a><a name=\"mp684a35c27d00abaf233bd95a3f24554a-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/16/1119/001</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>: ZEPATIER 50 mg/100 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/1/16/1119/001" ] ] ) ; # 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 "ZEPATIER 50 mg/100 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.
