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-d7f220f9031e8b4b6b6e866b11abbe3a"] ; # 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-d7f220f9031e8b4b6b6e866b11abbe3a"^^xsd:anyURI ] ; ( fhir:resource <Composition/composition-en-d7f220f9031e8b4b6b6e866b11abbe3a> ) ] [ fhir:fullUrl [ fhir:v "MedicinalProductDefinition/mpd7f220f9031e8b4b6b6e866b11abbe3a"^^xsd:anyURI ] ; ( fhir:resource <MedicinalProductDefinition/mpd7f220f9031e8b4b6b6e866b11abbe3a> ) ] ) . # <Composition/composition-en-d7f220f9031e8b4b6b6e866b11abbe3a> a fhir:Composition ; fhir:id [ fhir:v "composition-en-d7f220f9031e8b4b6b6e866b11abbe3a"] ; # 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-d7f220f9031e8b4b6b6e866b11abbe3a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-d7f220f9031e8b4b6b6e866b11abbe3a</b></p><a name=\"composition-en-d7f220f9031e8b4b6b6e866b11abbe3a\"> </a><a name=\"hccomposition-en-d7f220f9031e8b4b6b6e866b11abbe3a\"> </a><a name=\"composition-en-d7f220f9031e8b4b6b6e866b11abbe3a-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/1/16/1086/001 40 mg 30 film-coated tablets</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 - tagrisso</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/1/16/1086/001 40 mg 30 film-coated tablets" ] ] ) ; # 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/mpd7f220f9031e8b4b6b6e866b11abbe3a" ] ] ) ; # 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 - tagrisso"] ; # 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 TAGRISSO is and what it is used for</li><li>What you need to know before you take TAGRISSO</li><li>How to take TAGRISSO</li><li>Possible side effects</li><li>How to store TAGRISSO</li><li>Contents of the pack and other information</li></ol></div>" ] ] [ fhir:title [ fhir:v "1. What tagrisso 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 tagrisso 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>TAGRISSO contains the active substance osimertinib, which belongs to a group of medicines called protein kinase inhibitors which are used to treat cancer. TAGRISSO is used to treat adults with a type of lung cancer called non-small cell lung cancer. If a test has shown that your cancer has certain changes (mutations) in a gene called EGFR (epidermal growth factor receptor) your cancer is likely to respond to treatment with TAGRISSO. TAGRISSO can be prescribed for you:</p><p>after complete removal of your cancer as a post-surgical (adjuvant) treatment or</p><p>as the first medicine you receive for your cancer which has spread to other parts of the body or</p><p>in certain circumstances if you have been treated for your cancer before with other protein kinase inhibitor medicines. How TAGRISSO works TAGRISSO works by blocking EGFR and may help to slow or stop your lung cancer from growing. It may also help to reduce the size of the tumour and prevent the tumour from coming back after removal by surgery.</p><p>If you are receiving TAGRISSO after complete removal of your cancer, it means that your cancer contained defects in the EGFR gene, exon 19 deletion or exon 21 substitution mutation .</p><p>If TAGRISSO is the first protein kinase inhibitor medicine you are receiving, it means that your cancer contains defects in the EGFR gene, for example exon 19 deletion or exon 21 substitution mutation .</p><p>If your cancer has progressed while you were being treated with other protein kinase inhibitor medicines, it means that your cancer contains a gene defect called T790M . Because of this defect, other protein kinase medicines may no longer work. If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor.</p></div>" ] ] [ fhir:title [ fhir:v "2. What you need to know before you take tagrisso" ] ; 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 tagrisso" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not take TAGRISSO if:</p><p>you are allergic (hypersensitive) to osimertinib or any of the other ingredients of this medicine (listed in section 6).</p><p>you are taking St. John s Wort (Hypericum perforatum). If you are not sure, talk to your doctor, pharmacist or nurse before taking TAGRISSO. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking TAGRISSO if:</p><p>you have suffered from inflammation of your lungs (a condition called interstitial lung disease ).</p><p>you have ever had heart problems your doctor may want to keep a close eye on you.</p><p>you have a history of eye problems. If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine. Tell your doctor straight away while taking this medicine if:</p><p>you have sudden difficulty in breathing together with a cough or fever.</p><p>you have severe peeling of your skin.</p><p>you have rapid or irregular heartbeats, dizziness, light-headedness, chest discomfort, shortness of breath and fainting.</p><p>you have watery eyes, sensitivity to light, eye pain, eye redness or vision changes. See Serious side effects in section 4 for more information.</p><p>you develop persistent fever, bruising or bleeding more easily, increasing tiredness, pale skin and infection. See Serious side effects in section 4 for more information. Children and adolescents TAGRISSO has not been studied in children or adolescents. Do not give this medicine to children or adolescents under the age of 18 years. Other medicines and TAGRISSO 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. This is because TAGRISSO can affect the way some other medicines work. Also some other medicines can affect the way TAGRISSO works. Tell your doctor before taking TAGRISSO if you are taking any of the following medicines: The following medicines may reduce how well TAGRISSO works:</p><p>Phenytoin, carbamazepine or phenobarbital used for seizures or fits.</p><p>Rifabutin or rifampicin used for tuberculosis (TB).</p><p>St. John s Wort (Hypericum perforatum) an herbal medicine used for depression. TAGRISSO may affect how well the following medicines work and/or increase side effects of these medicines:</p><p>Rosuvastatin used to lower cholesterol.</p><p>Oral hormonal contraceptive pill used to prevent pregnancy.</p><p>Bosentan used for high blood pressure in the lungs.</p><p>Efavirenz and etravirine used to treat HIV infections/AIDS.</p><p>Modafinil used for sleep disorders.</p><p>Dabigatran used to prevent blood clots.</p><p>Digoxin used for irregular heart beat or other heart problems.</p><p>Aliskiren used for high blood pressure. If you are taking any of the medicines listed above, tell your doctor before taking TAGRISSO. Your doctor will discuss appropriate treatment options with you. Pregnancy information for women</p><p>If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. If you do become pregnant during treatment, tell your doctor straight away. Your doctor will decide with you whether you should carry on taking TAGRISSO.</p><p>You should not become pregnant while taking this medicine. If you are able to become pregnant, you must use effective contraception. See Contraception - information for women and men below.</p><p>If you plan to become pregnant after taking the last dose of this medicine, ask your doctor for advice. This is because some medicine may remain in your body, (see advice on contraception below). Pregnancy information for men</p><p>If your partner becomes pregnant while you are taking this medicine, tell your doctor straight away. Contraception information for women and men You must use effective contraception during treatment.</p><p>TAGRISSO may interfere with how well oral hormonal contraceptives work. Discuss with your doctor the most appropriate methods of contraception.</p><p>TAGRISSO may pass into semen. Therefore, it is important that men also use effective contraception. You must also do this after completing treatment with TAGRISSO:</p><p>Women keep using contraception for 2 months after.</p><p>Men keep using contraception for 4 months after. Breast-feeding Do not breast-feed while taking this medicine. This is because it is not known if there is a risk to your baby. Driving and using machines TAGRISSO has no or no marked influence on the ability to drive and use machines. TAGRISSO 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 tagrisso" ] ; 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 tagrisso" ] ] ; 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. How much to take</p><p>The recommended dose is one 80 mg tablet each day.</p><p>If necessary, your doctor may reduce your dose to one 40 mg tablet each day. How to take</p><p>TAGRISSO is taken by mouth. Swallow the tablet whole with water. Do not crush, split or chew the tablet.</p><p>Take TAGRISSO every day at the same time.</p><p>You can take this medicine with or without food. If you have trouble swallowing the tablet, you can mix it in water:</p><p>Put the tablet in a glass.</p><p>Add 50 mL (about two-thirds of a tumblerful) of still (non-fizzy) water do not use any other liquids.</p><p>Stir the water until the tablet breaks up into very small pieces - the tablet will not completely dissolve.</p><p>Drink the liquid straight away.</p><p>To make sure you have taken all of the medicine, rinse the glass thoroughly with another 50 mL of water and drink it. If you take more TAGRISSO than you should If you take more than your normal dose, contact your doctor or nearest hospital straight away. If you forget to take TAGRISSO If you forget a dose, take it as soon as you remember it. However, if it is less than 12 hours until your next dose is due, skip the missed dose. Take your next normal dose at its scheduled time. If you stop taking TAGRISSO Do not stop taking this medicine - talk to your doctor first. It is important to take this medicine every day, for as long as your doctor prescribes it for you. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.</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. Serious side effects Tell your doctor straight away if you notice the following serious side effects (see also section 2):</p><p>Sudden difficulty in breathing together with a cough or fever - this may be a sign of inflamed lungs (a condition called interstitial lung disease ). Most cases can be treated but some cases have been fatal. Your doctor may wish to stop TAGRISSO if you get this side effect. This side effect is common: it may affect up to 1 in 10 people.</p><p>Stevens-Johnson syndrome and toxic epidermal necrolysis, which can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and be preceded by fever and flu-like symptoms. Stevens-Johnson syndrome is rare: it may affect up to 1 in 1000 people. The frequency of toxic epidermal necrolysis cannot be determined as cases have only been reported since marketing TAGRISSO.</p><p>Changes in the electrical activity in the heart (QTc prolongation) such as rapid or irregular heartbeats, dizziness, light-headedness, chest discomfort, shortness of breath and fainting. This side effect is uncommon: it may affect up to 1 in 100 people.</p><p>If you develop watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. This side effect is uncommon: it may affect up to 1 in 100 people.</p><p>A blood disorder called aplastic anaemia, when bone marrow stops producing new blood cells<br/>signs suggestive of this blood disorder may include persistent fever, bruising or bleeding more easily, increased tiredness and a decrease in your ability to fight infection. This side effect is rare: it may affect up to 1 in 1000 people.</p><p>A condition in which the heart does not pump enough blood out of the heart in one beat as well as it should which could result in shortness of breath, tiredness and ankle swelling (suggestive of heart failure or left ventricular ejection fraction decreased). Tell your doctor straight away if you notice the serious side effects listed above. Other side effects Very common (may affect more than 1 in 10 people)</p><p>Diarrhoea - this may come and go during treatment. Tell your doctor if your diarrhoea does not go away or becomes severe.</p><p>Skin and nail problems - signs may include pain, itching, dry skin, rash, redness around the fingernails. This is more likely in areas exposed to the sun. Using moisturisers regularly on your skin and nails can help with this. Tell your doctor if your skin or nail problems get worse.</p><p>Stomatitis - inflammation of the inner lining of the mouth or ulcers forming in the mouth.</p><p>Loss of appetite.</p><p>Reduction in the number of white blood cells (leukocytes, lymphocytes or neutrophils).</p><p>Reduction in the number of platelets in the blood. Common (may affect up to 1 in 10 people)</p><p>Nose bleed (epistaxis).</p><p>Hair thinning (alopecia).</p><p>Hives (urticaria) - itchy, raised patches anywhere on the skin, which may be pink or red and round in shape. Tell your doctor if you notice this side effect.</p><p>Hand-foot syndrome this may include redness, swelling, tingling or burning sensation with cracking of the skin on the palms of hands and/or soles of feet.</p><p>Increase of a substance in the blood called creatinine (produced by your body and removed by the kidney).</p><p>Increase of a substance in the blood called creatine phosphokinase (an enzyme released into the blood when muscle is damaged). Uncommon (may affect up to 1 in 100 people)</p><p>Target lesions, which are skin reactions that look like rings (suggestive of Erythema multiforme).</p><p>Inflammation of the blood vessels in the skin. This may give the appearance of bruising or redness of the skin that does not fade in colour when pressed (non-blanching). Rare (may affect up to 1 in 1000 people)</p><p>Inflammation of the muscle which may result in muscle pain or weakness Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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 tagrisso" ] ; 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 tagrisso" ] ] ; 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 this medicine after the expiry date which is stated on the blister foil and carton after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not use this medicine if the pack is damaged or shows signs of tampering. 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 TAGRISSO contains</p><p>The active substance is osimertinib (as mesylate). Each 40 mg film-coated tablet contains 40 mg of osimertinib. Each 80 mg film-coated tablet contains 80 mg of osimertinib.</p><p>The other ingredients are mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide, red iron oxide, black iron oxide (see section 2 TAGRISSO contains sodium ). What TAGRISSO looks like and contents of the pack TAGRISSO 40 mg is supplied as beige, film-coated, round and biconvex tablets, marked with AZ and 40 on one side, and plain on the other. TAGRISSO 80 mg is supplied as beige, film-coated, oval and biconvex tablets, marked with AZ and 80 on one side, and plain on the other. TAGRISSO is supplied in blisters containing 30 x 1 film-coated tablets, packed in cartons containing 3 blisters of 10 tablets each. TAGRISSO is supplied in blisters containing 28 x 1 film-coated tablets, packed in cartons containing 4 blisters of 7 tablets each. Marketing Authorisation Holder AstraZeneca AB SE-151 85 S dert lje Sweden Manufacturer AstraZeneca AB G rtunav gen SE-152 57 S dert lje Sweden For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. Belgi /Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660</p><p>.: +359 24455Luxembourg/Luxemburg AstraZeneca S.A./N.V. T l/Tel: +32 2 370 48 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft. Tel.: +36 1 883 6Danmark AstraZeneca A/S Tlf: +45 43 66 64 Malta Associated Drug Co. Ltd Tel: +356 2277 8Deutschland AstraZeneca GmbH Tel: +49 40 80 90 34Nederland AstraZeneca BV Tel: +31 79 363 2Eesti AstraZeneca Tel: +372 6549 Norge AstraZeneca AS Tlf: +47 21 00 64<br/>AstraZeneca A.E. : +30 210 6871 sterreich AstraZeneca sterreich GmbH Tel: +43 1 711 31 0 Espa a AstraZeneca Farmac utica Spain, S.A. Tel: +34 91 301 91 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 France AstraZeneca T l: +33 1 41 29 40 Portugal AstraZeneca Produtos Farmac uticos, Lda. Tel: +351 21 434 61 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 sland Vistor hf. S mi: +354 535 7Slovensk republika AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia AstraZeneca S.p.A. Tel: +39 02 00704Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23</p><p>: +357 22490Sverige AstraZeneca AB Tel: +46 8 553 26 Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>" ] ] ) ] ) . # <MedicinalProductDefinition/mpd7f220f9031e8b4b6b6e866b11abbe3a> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "mpd7f220f9031e8b4b6b6e866b11abbe3a"] ; # 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_mpd7f220f9031e8b4b6b6e866b11abbe3a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mpd7f220f9031e8b4b6b6e866b11abbe3a</b></p><a name=\"mpd7f220f9031e8b4b6b6e866b11abbe3a\"> </a><a name=\"hcmpd7f220f9031e8b4b6b6e866b11abbe3a\"> </a><a name=\"mpd7f220f9031e8b4b6b6e866b11abbe3a-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/16/1086/001 40 mg 30 film-coated tablets</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>: TAGRISSO 40 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/1/16/1086/001 40 mg 30 film-coated tablets" ] ] ) ; # 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 "TAGRISSO 40 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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