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

: ePI document Bundle for delstrigo Package Leaflet for language en - XML Representation

Raw xml | Download


<Bundle xmlns="http://hl7.org/fhir">
  <id value="bundlepackageleaflet-en-cba1fe141abc835da1e9a47ec8c07d56"/>
  <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-cba1fe141abc835da1e9a47ec8c07d56"/>
    <resource>
      <Composition>
        <id value="composition-en-cba1fe141abc835da1e9a47ec8c07d56"/>
        <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-cba1fe141abc835da1e9a47ec8c07d56"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-en-cba1fe141abc835da1e9a47ec8c07d56</b></p><a name="composition-en-cba1fe141abc835da1e9a47ec8c07d56"> </a><a name="hccomposition-en-cba1fe141abc835da1e9a47ec8c07d56"> </a><a name="composition-en-cba1fe141abc835da1e9a47ec8c07d56-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/1/18/1333/001</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 - delstrigo</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/1/18/1333/001"/>
        </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/mpcba1fe141abc835da1e9a47ec8c07d56"/>
        </subject>
        <date value="2022-02-16T13:28:17Z"/>
        <author>🔗 
          <reference value="Organization/mah-ema"/>
        </author>
        <title value="TEST PURPOSES ONLY - delstrigo"/>
        <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"></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 Delstrigo is and what it is used for</li><li>What you need to know before you take Delstrigo</li><li>How to take Delstrigo</li><li>Possible side effects</li><li>How to store Delstrigo</li><li>Contents of the pack and other information</li></ol></div>
            </text>
          </section>
          <section>
            <title value="1. What delstrigo 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 delstrigo is and what it is used for"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><p>What Delstrigo is Delstrigo is used to treat HIV ( human immunodeficiency virus ) infection. It belongs to a group of medicines called antiretroviral medicines . Delstrigo contains the active substances:</p><ul><li>Doravirine - a non-nucleoside reverse transcriptase inhibitor (NNRTI)</li><li>Lamivudine - a nucleoside analogue reverse transcriptase inhibitor (NRTI)</li><li>Tenofovir disoproxil - a nucleoside analogue reverse transcriptase inhibitor (NRTI) What Delstrigo is used for Delstrigo is used to treat HIV infection in adults, and adolescents aged 12 years and older weighing at least 35 kg. HIV is the virus that causes AIDS ( acquired immune deficiency syndrome ). You should not take Delstrigo if your doctor has told you that the virus causing your infection is resistant to any of the medicines in Delstrigo. How Delstrigo works Delstrigo works by preventing HIV from making more viruses in your body. This will help by:</li><li>reducing the amount of HIV in your blood (this is called your viral load )</li><li>increasing the number of white blood cells called CD4+ T . This can make your immune system stronger. This may reduce your risk of early death or catching infections because your immune system is weak.</li></ul></div>
            </text>
          </section>
          <section>
            <title
                   value="2. What you need to know before you take delstrigo"/>
            <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 delstrigo"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><p>Do not take Delstrigo</p><ul><li>if you are allergic to doravirine, lamivudine or tenofovir disoproxil or any of the other ingredients of this medicine listed in section 6. * if you are taking any of the following medicines:</li></ul><ul><li>carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for seizure)</li><li>rifampicin, rifapentine (medicines for tuberculosis)</li><li>St. John s wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it</li><li>mitotane (a medicine to treat cancer)</li><li>enzalutamide (a medicine to treat prostate cancer)</li><li>lumacaftor (a medicine to treat cystic fibrosis) Do not take Delstrigo if the above applies to you. If you are not sure, talk to your doctor, pharmacist, or nurse before taking Delstrigo. See also the list in section Other Medicines and Delstrigo . Warnings and precautions Talk to your doctor, pharmacist, or nurse before taking Delstrigo. Worsening of hepatitis B infection If you have both HIV and hepatitis B virus infections, your hepatitis B may get worse if you stop taking Delstrigo. You may require blood tests for several months after stopping treatment. Discuss your hepatitis B therapy with your doctor. New or worsening kidney problems, including kidney failure This can happen in some people who take Delstrigo. Your doctor will do blood tests to check your kidney function before and during treatment with Delstrigo. Bone problems This can happen in some people who take Delstrigo. Bone problems include bone pain, and bone softening or thinning (which may lead to fractures). Joint or muscle pain or muscle weakness may also occur. Your doctor may need to do additional tests to check your bones. Immune reactivation syndrome This can happen when you start taking any HIV medicine, including Delstrigo. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having any new symptoms after starting your HIV medicine. Autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment. Children and adolescents Do not give this medicine to children aged less than 12 years or weighing less than 35 kg. The use of Delstrigo in children aged less than 12 years or weighing less than 35 kg has not yet been studied. Other medicines and Delstrigo Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because other medicines may affect how Delstrigo works, and Delstrigo might affect the way some other medicines work. There are some medicines you must not take with Delstrigo. See list under Do not take Delstrigo section. Talk to your doctor before taking the following medicines with Delstrigo as your doctor may need to change the dose of your medicines:</li></ul><ul><li>bosentan (a medicine to treat lung disease)</li><li>dabrafenib (a medicine to treat skin cancer)</li><li>lesinurad (a medicine to treat gout)</li><li>modafinil (a medicine to treat excessive sleepiness)</li><li>nafcillin (a medicine to treat some bacterial infections)</li><li>rifabutin (a medicine to treat some bacterial infections such as tuberculosis)</li><li>telotristat ethyl (a medicine to treat diarrhea in people with carcinoid syndrome)</li><li>thioridazine (a medicine to treat psychiatric conditions such as schizophrenia) If your doctor decides you should take these medicines with Delstrigo, your doctor will prescribe a 100 mg tablet of doravirine to be taken daily, approximately 12 hours after your dose of Delstrigo. Your doctor may check your blood levels or monitor for side effects if you take the following medicines with Delstrigo:</li><li>ledipasvir/sofosbuvir (medicines used to treat hepatitis C infection)</li><li>sirolimus (a medicine used to control your body s immune response after a transplant)</li><li>sofosbuvir/velpatasvir (medicines used to treat hepatitis C infection)</li><li>tacrolimus (a medicine used to control your body s immune response after a transplant)</li><li>medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly Pregnancy and breast-feeding If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, talk to your doctor about the risks and benefits of taking Delstrigo. It is preferable to avoid the use of Delstrigo during pregnancy. This is because it has not been studied in pregnancy and it is not known if Delstrigo will harm your baby while you are pregnant. Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk. If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible. Driving and using machines Use with caution when driving, riding a bicycle, or operating machines if you feel tired, dizzy, or sleepy after taking this medicine Delstrigo tablets contains lactose If you have been told by your doctor that you have an intolerance to lactose, talk to your doctor before taking this medicine.</li></ul></div>
            </text>
          </section>
          <section>
            <title value="3. How to take delstrigo"/>
            <code>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi/"/>
                <code value="100000155538"/>
              </coding>
              <text value="3. How to take delstrigo"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><p>Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. Check with your doctor, pharmacist, or nurse if you are not sure. Delstrigo is a complete regimen taken as a single tablet for the treatment of HIV infection. How much to take The recommended dose is 1 tablet once a day. If you take certain medicines your doctor may need to change the amount of doravirine you take. See Other medicines and Delstrigo section for a list of medicines. Taking this medicine</p><ul><li>Swallow the tablet whole (do not crush or chew).</li><li>This medicine can be taken with food or between meals. If you take more Delstrigo than you should Do not take more than the recommended dose. If you accidentally take more, contact your doctor. If you forget to take Delstrigo</li><li>It is important that you do not miss or skip doses of Delstrigo.</li><li>If you forget a dose, take it as soon as you remember. But if your next dose is due within 12 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before.</li><li>Do not take two doses of Delstrigo at the same time to make up for a missed dose.</li><li>If you are not sure what to do, call your doctor or pharmacist. If you stop taking Delstrigo Do not run out of Delstrigo. Refill your prescription or talk to your doctor before your Delstrigo is all gone. If you stop taking Delstrigo, your doctor will need to check your health often and do blood tests regularly for several months to check your HIV infection. If you have HIV infection and hepatitis B infection, it is especially important not to stop your Delstrigo treatment without talking to your doctor first. Some patients have had blood tests or symptoms indicating that their hepatitis has worsened after stopping lamivudine or tenofovir disoproxil (two of the three active substances of Delstrigo). If Delstrigo is stopped your doctor may recommend that you resume hepatitis B treatment. You may need blood tests to check how your liver is working for 4 months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be life-threatening. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.</li></ul></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. Do not stop taking this medicine without first talking to your doctor. Common: may affect up to 1 in 10 people:</p><ul><li>abnormal dreams, difficulty in sleeping (insomnia)</li><li>headache, dizziness, sleepiness</li><li>cough, nasal symptoms</li><li>feeling sick (nausea), diarrhoea, stomach pain, vomiting, wind (flatulence)</li><li>hair loss, rash</li><li>muscle symptoms (pain, stiffness)</li><li>feeling tired, fever Blood tests may also show:</li><li>increased levels in liver enzymes (ALT) Uncommon: may affect up to 1 in 100 people:</li><li>nightmares, depression, anxiety, irritability, confusion, suicidal thoughts</li><li>trouble concentrating, memory problems, tingling of hands and feet, stiff muscles, poor quality of sleep</li><li>high blood pressure</li><li>constipation, stomach discomfort, swollen or bloated stomach (abdominal distention), indigestion, soft stools, stomach spasms, frequent bowel movements, inflammation of the pancreas (pancreatitis) (causing stomach pain, vomiting)</li><li>itchiness</li><li>joint pain, breakdown of muscle tissue, muscular weakness</li><li>feeling weak, general feeling of being unwell Blood tests may also show:</li><li>decreased number of white blood cells in your blood (neutropenia)</li><li>decreased number of red blood cells in your blood (anaemia)</li><li>decreased levels of platelets in your blood (you may bleed more easily)</li><li>decreased levels phosphate</li><li>decreased levels of potassium in your blood</li><li>increased levels of creatinine in your blood</li><li>increased levels in liver enzymes (AST)</li><li>increased levels of lipase</li><li>increased levels of amylase</li><li>decreased levels of haemoglobin The muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells. Rare: may affect up to 1 in 1 000 people:</li><li>aggression, hallucinations, difficulty adjusting to changes, mood changes, sleep walking</li><li>difficulty breathing, enlarged tonsils</li><li>feeling of incomplete defecation</li><li>enlarged liver or fatty liver, yellow skin or eyes, pain in the belly (abdomen) caused by inflammation of the liver</li><li>inflammation of the skin due to allergy, redness on the cheeks, nose, chin or forehead, bumps or pimples on the face, swelling of the face, lips, tongue or throat</li><li>muscle weakness, weakening of the bones (with bone pain and sometimes resulting in fractures)</li><li>kidney damage, kidney stones, kidney failure, damage to kidney tubule cells, kidney injury, passing a lot of urine and feeling thirsty</li><li>pain in the chest, feeling cold, pain, thirst Blood tests may also show:</li><li>decreased levels of magnesium</li><li>lactic acidosis (excess lactic acid in the blood)</li><li>increased levels of creatine phosphokinase Very rare: may affect up to 1 in 10 000 people: Blood tests may also show:</li><li>failure of the bone marrow to produce new red blood cells (pure red cell aplasia) 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.</li></ul></div>
            </text>
          </section>
          <section>
            <title value="5. How to store delstrigo"/>
            <code>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi/"/>
                <code value="100000155538"/>
              </coding>
              <text value="5. How to store delstrigo"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><ul><li>Keep this medicine out of the sight and reach of children.</li><li>Do not use this medicine after the expiry date which is stated on the bottle after EXP.</li><li>The bottle contains desiccant protecting the tablets from moisture. There may be more than one in the bottle. Keep desiccant inside the bottle and do not throw away until you have finished taking all of the medicine.</li><li>Keep the bottle tightly closed in order to protect from moisture.</li><li>This medicinal product does not require any special temperature storage conditions.</li><li>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.</li></ul></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 Delstrigo contains</p><ul><li>The active substances are 100 mg of doravirine, 300 mg of lamivudine and 245 mg of tenofovir disoproxil (as fumarate)</li><li>The other ingredients are croscarmellose sodium E468; hypromellose acetate succinate; magnesium stearate E470b; microcrystalline cellulose E460; silica, colloidal anhydrous E551; sodium stearyl fumarate. The tablets are film-coated with a coating material containing the following ingredients: carnauba wax E903, hypromellose E464; iron oxide yellow E172; lactose monohydrate; titanium dioxide E171; and triacetin E1518. What Delstrigo looks like and contents of the pack Delstrigo is available as a yellow, oval-shaped, film-coated tablet, and is debossed with the corporate logo and 776 on one side and plain on the other side. The following pack sizes are available:</li><li>1 bottle with 30 film-coated tablets</li><li>90 film-coated tablets (3 bottles of 30 film-coated tablets) Not all pack sizes may be available in your country. Marketing Authorisation Holder and Manufacturer Merck Sharp &amp; Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien MSD Belgium T l/Tel: +32(0)<a href="mailto:27766dpoc_belux@merck.com">27766dpoc_belux@merck.com</a> Lietuva UAB Merck Sharp &amp; Dohme Tel. + 370 5 278 02 <a href="mailto:msd_lietuva@merck.com">msd_lietuva@merck.com</a></li></ul><p>.: +359 2 819 <a href="mailto:3info-msdbg@merck.com">3info-msdbg@merck.com</a> Luxembourg/Luxemburg MSD Belgium T l/Tel: +32(0)<a href="mailto:27766dpoc_belux@merck.com">27766dpoc_belux@merck.com</a> esk republika Merck Sharp &amp; Dohme s.r.o. Tel: +420 233 010 <a href="mailto:dpoc_czechslovak@merck.com">dpoc_czechslovak@merck.com</a> Magyarorsz g MSD Pharma Hungary Kft. Tel.: +36 1 888 <a href="mailto:5hungary_msd@merck.com">5hungary_msd@merck.com</a> Danmark MSD Danmark ApS Tlf: + 45 4482 <a href="mailto:4dkmail@merck.com">4dkmail@merck.com</a> Malta Merck Sharp &amp; Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) <a href="mailto:malta_info@merck.com">malta_info@merck.com</a> Deutschland MSD Sharp &amp; Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0) <a href="mailto:e-mail@msd.de">e-mail@msd.de</a> Nederland Merck Sharp &amp; Dohme B.V. Tel: 0800 9999(+31 23 5153153) <a href="mailto:medicalinfo.nl@merck.com">medicalinfo.nl@merck.com</a> Eesti Merck Sharp &amp; Dohme O Tel.: +372 6144 <a href="mailto:msdeesti@merck.com">msdeesti@merck.com</a> Norge MSD (Norge) AS Tlf: +47 32 20 73 <a href="mailto:msdnorge@msd.no">msdnorge@msd.no</a></p><p>MSD . . . . . : +30 210 98 97 <a href="mailto:dpoc_greece@merck.com">dpoc_greece@merck.com</a> sterreich Merck Sharp &amp; Dohme Ges.m.b.H. Tel: +43 (0) 1 26 <a href="mailto:dpoc_austria@merck.com">dpoc_austria@merck.com</a> Espa a Merck Sharp &amp; Dohme de Espa a, S.A. Tel: +34 91 321 06 <a href="mailto:msd_info@merck.com">msd_info@merck.com</a> Polska MSD Polska Sp. z o.o. Tel: +48 22 549 51 <a href="mailto:msdpolska@merck.com">msdpolska@merck.com</a> France MSD France T l: + 33 (0) 1 80 46 40 Portugal Merck Sharp &amp; Dohme, Lda Tel: +351 21 <a href="mailto:4465inform_pt@merck.com">4465inform_pt@merck.com</a> Hrvatska: Merck Sharp &amp; Dohme d.o.o. Tel: + 385 1 6611 <a href="mailto:croatia_info@merck.com">croatia_info@merck.com</a> Rom nia Merck Sharp &amp; Dohme Romania S.R.L. Tel: +40 21 529 29 <a href="mailto:msdromania@merck.com">msdromania@merck.com</a> Ireland Merck Sharp &amp; Dohme Ireland (Human Health) Limited Tel: +353 (0)1 <a href="mailto:2998medinfo_ireland@merck.com">2998medinfo_ireland@merck.com</a> Slovenija Merck Sharp &amp; Dohme, inovativna zdravila d.o.o. Tel: +386 1 5204 <a href="mailto:msd.slovenia@merck.com">msd.slovenia@merck.com</a> sland Vistor hf. S mi: + 354 535 7Slovensk republika Merck Sharp &amp; Dohme, s. r. o. Tel: +421 2 <a href="mailto:58282dpoc_czechslovak@merck.com">58282dpoc_czechslovak@merck.com</a> Italia 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> Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 <a href="mailto:info@msd.fi">info@msd.fi</a></p><p>Merck Sharp &amp; Dohme Cyprus Limited .: 800 00 673 (+357 22866700) <a href="mailto:cyprus_info@merck.com">cyprus_info@merck.com</a> Sverige Merck Sharp &amp; Dohme (Sweden) AB Tel: +46 77 <a href="mailto:5700medicinskinfo@merck.com">5700medicinskinfo@merck.com</a> Latvija SIA Merck Sharp &amp; Dohme Latvija Tel: + 371 <a href="mailto:67364msd_lv@merck.com">67364msd_lv@merck.com</a> United Kingdom (Northern Ireland) Merck Sharp &amp; Dohme Ireland (Human Health) Limited Tel: +353 (0)1 <a href="mailto:2998medinfoNI@msd.com">2998medinfoNI@msd.com</a> This leaflet was last revised in {MM/YYYY} Other sources of information 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>
            </text>
          </section>
        </section>
      </Composition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="MedicinalProductDefinition/mpcba1fe141abc835da1e9a47ec8c07d56"/>
    <resource>
      <MedicinalProductDefinition>
        <id value="mpcba1fe141abc835da1e9a47ec8c07d56"/>
        <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_mpcba1fe141abc835da1e9a47ec8c07d56"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mpcba1fe141abc835da1e9a47ec8c07d56</b></p><a name="mpcba1fe141abc835da1e9a47ec8c07d56"> </a><a name="hcmpcba1fe141abc835da1e9a47ec8c07d56"> </a><a name="mpcba1fe141abc835da1e9a47ec8c07d56-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/18/1333/001</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>: Delstrigo 100 mg/300 mg/245 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>
        </text>
        <identifier>
          <system value="http://ema.europa.eu/identifier"/>
          <value value="EU/1/18/1333/001"/>
        </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="Delstrigo 100 mg/300 mg/245 mg film-coated tablets"/>
          <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>