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
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundlepackageleaflet-en-07dfba600182595cfe2f36d89c5d2642"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"/>
</meta>
<language value="en"/>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="None"/>
</identifier>
<type value="document"/>
<timestamp value="2023-06-27T10:09:22Z"/>
<entry>
<fullUrl
value="Composition/composition-en-07dfba600182595cfe2f36d89c5d2642"/>
<resource>
<Composition>
<id value="composition-en-07dfba600182595cfe2f36d89c5d2642"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><a name="Composition_composition-en-07dfba600182595cfe2f36d89c5d2642"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-en-07dfba600182595cfe2f36d89c5d2642</b></p><a name="composition-en-07dfba600182595cfe2f36d89c5d2642"> </a><a name="hccomposition-en-07dfba600182595cfe2f36d89c5d2642"> </a><a name="composition-en-07dfba600182595cfe2f36d89c5d2642-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/1/17/1237/001</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 - elebrato</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>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="EU/1/17/1237/001"/>
</identifier>
<status value="final"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="Package Leaflet"/>
</type>
<category>
<coding>
<system
value="http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs"/>
<code value="R"/>
<display value="Raw"/>
</coding>
</category>
<subject>
<reference
value="MedicinalProductDefinition/mp07dfba600182595cfe2f36d89c5d2642"/>
</subject>
<date value="2022-02-16T13:28:17Z"/>
<author>🔗
<reference value="Organization/mah-ema"/>
</author>
<title value="TEST PURPOSES ONLY - elebrato"/>
<attester>
<mode>
<coding>
<system
value="http://hl7.org/fhir/composition-attestation-mode"/>
<code value="official"/>
</coding>
</mode>
<time value="2022-02-16T13:28:17Z"/>
</attester>
<section>
<title value="B. Package Leaflet"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="B. Package Leaflet"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="Package leaflet: Information for the user"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="Package leaflet: Information for the user"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Step-by-step instructions</p></div>
</text>
</section>
<section>
<title value="What is in this leaflet"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="What is in this leaflet"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>What is in this leaflet</p><ol type="1"><li>What Elebrato Ellipta is and what it is used for</li><li>What you need to know before you use Elebrato Ellipta</li><li>How to use Elebrato Ellipta</li><li>Possible side effects</li><li>How to store Elebrato Ellipta</li><li>Contents of the pack and other information</li></ol></div>
</text>
</section>
<section>
<title value="1. What elebrato is and what it is used for"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="1. What elebrato is and what it is used for"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>What Elebrato Ellipta is</p><p>Elebrato Ellipta contains three active substances called fluticasone furoate, umeclidinium bromide and vilanterol. Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids. Umeclidinium bromide and vilanterol belong to a group of medicines called bronchodilators.</p><p>What Elebrato Ellipta is used for</p><p>Elebrato Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a long- term condition characterised by breathing difficulties that slowly get worse.</p><p>In COPD the muscles around the airways tighten, making breathing difficult. This medicine widens these muscles in the lungs, reducing the swelling and irritation in the small air passages and making it easier for air to get in and out of the lungs. When used regularly, it can help to control your breathing difficulties and reduce the effects of COPD on your everyday life.</p><p>Elebrato Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD. It should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting inhaler (such as salbutamol). If you do not have a quick-acting inhaler contact your doctor.</p></div>
</text>
</section>
<section>
<title value="2. What you need to know before you take elebrato"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text
value="2. What you need to know before you take elebrato"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not use Elebrato Ellipta:</p><ul><li>if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).</li></ul><p>Warnings and precautions<br/>Talk to your doctor before using Elebrato Ellipta</p><ul><li>if you have asthma (Do not use Elebrato Ellipta to treat asthma)</li><li>if you have heart problems or high blood pressure</li><li>if you have liver problems</li><li>if you have tuberculosis (TB) of the lung, or any long standing or untreated infections</li><li>if you have an eye problem called narrow-angle glaucoma</li><li>if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder</li><li>if you suffer from epilepsy</li><li>if you have thyroid gland problems</li><li>if you have low potassium in your blood</li><li>if you have a history of diabetes</li><li>if you experience blurred vision or other visual disturbances</li></ul><p>Check with your doctor if you think any of these may apply to you.</p><p>Immediate breathing difficulties If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Elebrato Ellipta inhaler: stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.</p><p>Eye problems during treatment with Elebrato Ellipta If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images as well as red eyes during treatment with Elebrato Ellipta:</p><p>stop using this medicine and seek medical help immediately. These may be signs of an acute attack of narrow-angle glaucoma.</p><p>Infection of the lung Because you are using this medicine for COPD you may be at an increased risk of developing an infection of the lungs known as pneumonia. See section 4 Possible side effects for information on symptoms to look out for while you are using this medicine.</p><p>Tell your doctor as soon as possible if you develop any of these symptoms.</p><p>Children and adolescents Do not give this medicine to children or adolescents below the age of 18 years.</p><p>Other medicines and Elebrato Ellipta Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are not sure what your medicine contains talk to your doctor or pharmacist.</p><p>Some medicines may affect how this medicine works, or make it more likely to have side effects. These include:</p><ul><li><p>medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems</p></li><li><p>ketoconazole or itraconazole, to treat fungal infections</p></li><li><p>clarithromycin or telithromycin, to treat bacterial infections</p></li><li><p>ritonavir or cobicistat, to treat HIV infection</p></li><li><p>medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets) or some medicines used to treat COPD and asthma (such as methylxanthine or steroids)</p></li><li><p>other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g. tiotropium, indacaterol. Do not use Elebrato Ellipta if you already use these medicines. Tell your doctor or pharmacist if you are taking any of these. Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Elebrato Ellipta.</p></li></ul><p>Pregnancy and breast-feeding<br/>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. Do not use this medicine if you are pregnant unless your doctor tells you that you can.</p><p>It is not known whether the ingredients of this medicine can pass into breast milk. If you are breast-feeding, you must check with your doctor before you use Elebrato Ellipta. Do not use this medicine if you are breast- feeding unless your doctor tells you that you can.</p><p>Driving and using machines<br/>It is unlikely that this medicine will affect your ability to drive or use machines.</p><p>Elebrato Ellipta contains lactose<br/>If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.</p></div>
</text>
</section>
<section>
<title value="3. How to take elebrato"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="3. How to take elebrato"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.</p><p>The recommended dose is one inhalation every day at the same time of day. You only need to inhale once a day because the effect of this medicine lasts for 24 hours.</p><p>Do not use more than your doctor tells you to use.</p><p>Use Elebrato Ellipta regularly It is very important that you use Elebrato Ellipta every day, as instructed by your doctor. This will help to keep you free of symptoms throughout the day and night.</p><p>Elebrato Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol).</p><p>How to use the inhaler See Step-by-step instructions at the end of this leaflet for full information.</p><p>Elebrato Ellipta is for inhalation use.</p><p>Once the tray is opened Elebrato Ellipta is ready to use.</p><p>If your symptoms do not improve<br/>If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often:</p><p>contact your doctor as soon as possible.</p><p>If you use more Elebrato Ellipta than you should<br/>If you accidentally use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention. If possible, show them the inhaler, the package or this leaflet. You may notice that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, or have a headache. If you forget to use Elebrato Ellipta<br/>Do not inhale a double dose to make up for a forgotten dose. Just inhale your next dose at the usual time. If you become wheezy or breathless, use your quick-acting inhaler (such as salbutamol), then seek medical advice.</p><p>If you stop using Elebrato Ellipta<br/>Use this medicine for as long as your doctor recommends. Do not stop unless your doctor advises you to, even if you feel better, as your symptoms may get worse.</p><p>If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.</p></div>
</text>
</section>
<section>
<title value="4. Possible side effects"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="4. Possible side effects"/>
</code>
<text>
<status value="additional"/>
<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>Allergic reactions Allergic reactions to Elebrato Ellipta are rare (they may affect up to 1 in 1 000 people). If you have any of the following symptoms after taking Elebrato Ellipta, stop using it and tell your doctor immediately:</p><ul><li>skin rash or redness, hives (urticaria)</li><li>swelling, sometimes of the face or mouth (angioedema)</li><li>wheezing, coughing or having difficulty in breathing</li><li>suddenly feeling weak or light headed (may lead to collapse or loss of consciousness)</li></ul><p>Immediate breathing difficulties If your breathing or wheezing gets worse straight after using this medicine, stop using it and get medical help immediately.</p><p>Pneumonia (infection of the lung) in COPD patients (common side effect) Tell your doctor if you have any of the following while using Elebrato Ellipta these could be symptoms of a lung infection:</p><ul><li>fever or chills</li><li>increased mucus production, change in mucus colour</li><li>increased cough or increased breathing difficulties</li></ul><p>Other side effects</p><p>Common (may affect up to 1 in 10 people)</p><ul><li>sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis). Rinsing your mouth out with water immediately after using Elebrato Ellipta may help prevent this side effect.</li><li>infection of the nose, sinuses or throat</li><li>infection of the upper airways</li><li>itchy, runny or blocked nose</li><li>pain in the back of the mouth and throat</li><li>inflammation of the sinuses</li><li>inflammation of the lungs (bronchitis)</li><li>flu (influenza)</li><li>common cold</li><li>headache</li><li>cough</li><li>painful and frequent urination (may be signs of a urinary tract infection)</li><li>joint pain</li><li>back pain</li><li>constipation. Uncommon (may affect up to 1 in 100 people)</li><li>irregular heart beat</li><li>faster heart beat</li><li>hoarseness</li><li>weakening of the bones, leading to fractures</li><li>dry mouth</li><li>taste disturbance</li><li>blurred vision</li><li>increased eye pressure</li><li>eye pain.</li></ul><p>Rare (may affect up to 1 in 1 000 people)</p><ul><li>allergic reactions (see earlier in Section 4)</li><li>difficulties passing urine (urinary retention)</li><li>pain or discomfort passing urine (dysuria)</li><li>awareness of heart beat (palpitations)</li><li>anxiety</li><li>tremor</li><li>muscle spasms</li><li>increase in blood sugar (hyperglycaemia).</li></ul><p>Reporting of side effects<br/>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>
</text>
</section>
<section>
<title value="5. How to store elebrato"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="5. How to store elebrato"/>
</code>
<text>
<status value="additional"/>
<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 carton, tray and inhaler after EXP . The expiry date refers to the last day of that month.</p><p>Do not store above 30 C.</p><p>Keep the inhaler inside the sealed tray in order to protect from moisture and only remove immediately before first use. Once the tray is opened, the inhaler can be used for up to 6 weeks, starting from the date of opening the tray. Write the date the inhaler should be thrown away on the label in the space provided. The date should be added as soon as the inhaler has been removed from the tray.</p><p>If stored in a refrigerator, allow the inhaler to return to room temperature for at least one hour before use.</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>
</text>
</section>
<section>
<title value="6. Contents of the pack and other information"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="6. Contents of the pack and other information"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>What Elebrato Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.</p><p>Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate, 65 micrograms umeclidinium bromide equivalent to 55 micrograms umeclidinium and 22 micrograms of vilanterol (as trifenatate). The other ingredients are lactose monohydrate (see section 2 under Elebrato Ellipta contains lactose ) and magnesium stearate.</p><p>What Elebrato Ellipta looks like and contents of the pack Elebrato Ellipta is an inhalation powder, pre-dispensed. The Ellipta inhaler consists of a light grey plastic body, a beige coloured mouthpiece cover and a dose counter. It is packaged in a foil laminate tray with a peelable foil lid. The tray contains a desiccant sachet, to reduce moisture in the packaging.</p><p>The active substances are present as a white powder in separate blister strips inside the inhaler.<br/>Elebrato Ellipta is available in packs of 1 inhaler containing either 14 or 30 doses (14 or 30 day supply) and in multipacks containing 90 (3 inhalers of 30) doses (90 day supply). Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder</p><p>GlaxoSmithKline Trading Services Limited 12 Riverwalk Citywest Business Campus Dublin Ireland</p><p>Manufacturer<br/>Glaxo Wellcome Production Zone Industrielle No.2 23 Rue Lavoisier 27000 Evreux<br/>France</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. T l/Tel: + 32 (0) 10 85 52 Lietuva UAB BERLIN-CHEMIE MENARINI BALTIC<br/>Tel: + 370 52 691 <a href="mailto:lt@berlin-chemie.com">lt@berlin-chemie.com</a></p><ul><li>/ .<br/>E<br/>Te .: + 359 2 454 <a href="mailto:0bcsofia@berlin-chemie.com">0bcsofia@berlin-chemie.com</a></li></ul><p>Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien T l/Tel: + 32 (0) 10 85 52 esk republika GlaxoSmithKline, s.r.o. Tel: + 420 222 001 <a href="mailto:cz.info@gsk.com">cz.info@gsk.com</a></p><p>Magyarorsz g Berlin-Chemie/A. Menarini Kft. Tel.: + 36 <a href="mailto:23501bc-hu@berlin-chemie.com">23501bc-hu@berlin-chemie.com</a></p><p>Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 <a href="mailto:dk-info@gsk.com">dk-info@gsk.com</a></p><p>Malta GlaxoSmithKline Trading Services Limited<br/>Tel: + 356 80065Deutschland Berlin-Chemie AG Tel: +49 (0) 30 67Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081Eesti O Berlin-Chemie Menarini Eesti<br/>Tel: + 372 667 <a href="mailto:5ee@berlin-chemie.com">5ee@berlin-chemie.com</a></p><p>Norge GlaxoSmithKline AS Tlf: + 47 22 70 20<br/>Guidotti Hellas A.E. : + 30 210 8316111- sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 <a href="mailto:at.info@gsk.com">at.info@gsk.com</a></p><p>Espa a FAES FARMA, S.A. Tel: + 34 900 460 <a href="mailto:aweber@faes.es">aweber@faes.es</a> Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France Menarini France T l: + 33 (0)1 45 60 77 Portugal BIAL, Portela & Ca. SA. Tel: + 351 22 986 61 <a href="mailto:info@bial.com">info@bial.com</a></p><p>Hrvatska Berlin-Chemie Menarini Hrvatska d.o.o. Tel: + 385 1 4821 <a href="mailto:office-croatia@berlin-chemie.com">office-croatia@berlin-chemie.com</a></p><p>Rom nia GlaxoSmithKline Trading Services Limited<br/>Tel: + 40 800672Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Slovenija Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: + 386 (0)1 300 <a href="mailto:2slovenia@berlin-chemie.com">2slovenia@berlin-chemie.com</a></p><p>sland Vistor hf. S mi: +354 535 7Slovensk republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: + 421 2 544 30 <a href="mailto:slovakia@berlin-chemie.com">slovakia@berlin-chemie.com</a></p><p>Italia A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39 (0)55 56Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30<br/>GlaxoSmithKline Trading Services Limited : + 357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 <a href="mailto:info.produkt@gsk.com">info.produkt@gsk.com</a></p><p>Latvija SIA Berlin-Chemie/Menarini Baltic<br/>Tel: + 371 <a href="mailto:67103lv@berlin-chemie.com">67103lv@berlin-chemie.com</a> United Kingdom (Northern Ireland) GlaxoSmithKline Trading Services Limited Tel: + 44 (0)800 <a href="mailto:221customercontactuk@gsk.com">221customercontactuk@gsk.com</a></p><p>This leaflet was last revised in .</p><p>Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>
</text>
</section>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl
value="MedicinalProductDefinition/mp07dfba600182595cfe2f36d89c5d2642"/>
<resource>
<MedicinalProductDefinition>
<id value="mp07dfba600182595cfe2f36d89c5d2642"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mp07dfba600182595cfe2f36d89c5d2642"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mp07dfba600182595cfe2f36d89c5d2642</b></p><a name="mp07dfba600182595cfe2f36d89c5d2642"> </a><a name="hcmp07dfba600182595cfe2f36d89c5d2642"> </a><a name="mp07dfba600182595cfe2f36d89c5d2642-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/17/1237/001</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>: Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed</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>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="EU/1/17/1237/001"/>
</identifier>
<type>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-type"/>
<code value="MedicinalProduct"/>
<display value="Medicinal Product"/>
</coding>
</type>
<domain>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-domain"/>
<code value="Human"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="active"/>
</coding>
</status>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072084"/>
<display
value="Medicinal product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<name>
<productName
value="Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000001"/>
<display value="Full name"/>
</coding>
</type>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000002"/>
<display value="Invented name part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000003"/>
<display value="Scientific name part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000005"/>
<display value="Pharmaceutical dose form part"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EU"/>
<display value="EU"/>
</coding>
</country>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EU"/>
<display value="EU"/>
</coding>
</jurisdiction>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="en"/>
<display value="en"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
</Bundle>
IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.ghepi#0.1.0 based on FHIR 5.0.0. Generated 2024-10-14
Links: Table of Contents |
QA Report
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.
