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-82ed3b7e13571c65c8c961f4a21dd3e2"/>
<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-82ed3b7e13571c65c8c961f4a21dd3e2"/>
<resource>
<Composition>
<id value="composition-en-82ed3b7e13571c65c8c961f4a21dd3e2"/>
<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-82ed3b7e13571c65c8c961f4a21dd3e2"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-en-82ed3b7e13571c65c8c961f4a21dd3e2</b></p><a name="composition-en-82ed3b7e13571c65c8c961f4a21dd3e2"> </a><a name="hccomposition-en-82ed3b7e13571c65c8c961f4a21dd3e2"> </a><a name="composition-en-82ed3b7e13571c65c8c961f4a21dd3e2-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/1/01/189/001-003</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 - replagal</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/1/01/189/001-003"/>
</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/mp82ed3b7e13571c65c8c961f4a21dd3e2"/>
</subject>
<date value="2022-02-16T13:28:17Z"/>
<author>🔗
<reference value="Organization/mah-ema"/>
</author>
<title value="TEST PURPOSES ONLY - replagal"/>
<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 Replagal is and what it is used for</li><li>What you need to know before you are given Replagal</li><li>How Replagal is given</li><li>Possible side effects</li><li>How to store Replagal</li><li>Contents of the pack and other information</li></ol></div>
</text>
</section>
<section>
<title value="1. What replagal 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 replagal is and what it is used for"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>The active substance in Replagal is agalsidase alfa (1 mg/ml). Agalsidase alfa is a form of the human enzyme -galactosidase. It is produced by switching on the gene for -galactosidase A in cells. The enzyme is then removed from the cells and made into a sterile concentrate for solution for infusion. Replagal is used to treat adult patients, as well as adolescents and children from the age of 7, with confirmed diagnosis of Fabry Disease. It is used as long-term enzyme replacement therapy when the level of enzyme in the body is absent or lower than normal as in Fabry Disease. After 6 months of therapy Replagal significantly reduced pain in patients when compared to placebo (dummy) treated patients. Replagal reduced left ventricle mass in treated patients compared to placebo treated patients. These results suggest the symptoms of the disease are improving or the disease is becoming stable.</p></div>
</text>
</section>
<section>
<title value="2. What you need to know before you take replagal"/>
<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 replagal"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><h2 id="you-must-not-be-given-replagal">You must not be given Replagal</h2><h2 id="if-you-are-allergic-to-agalsidase-alfa-or-any-of-the-other-ingredients-of-this-medicine-listed-in-section-6-warnings-and-precautions-talk-to-your-doctor-or-pharmacist-before-replagal-is-used-if-you-notice-any-of-these-effects-during-or-after-an-infusion-you-should-tell-your-doctor-immediately">if you are allergic to agalsidase alfa or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before Replagal is used. If you notice any of these effects during or after an infusion you should tell your doctor immediately:</h2><h2 id="high-fever-chills-sweating-fast-heart-rate">high fever, chills, sweating, fast heart rate.</h2><h2 id="vomiting">vomiting.</h2><h2 id="light-headedness">light-headedness.</h2><h2 id="hives">hives.</h2><p>swelling in your hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing. Your doctor may stop the infusion temporarily (5 10 min) until the symptoms go away and then begin the infusion again. Your doctor may also treat the symptoms with other medicines (antihistamines or corticosteroids). Most of the time you can still be given Replagal even if these symptoms occur. If you experience a severe allergic (anaphylactic-type) reaction, the administration of Replagal will be immediately discontinued and an appropriate treatment will have to be initiated by your doctor. If treatment with Replagal makes your body produce antibodies this will not stop Replagal from working and the antibodies may disappear with time. If you have advanced renal disease, you may find that your Replagal treatment has a limited effect on your kidneys. Talk to your doctor or pharmacist before using Replagal. Children The experience in children 0-6 years old is limited and therefore no dose can be recommended for this age group. Other medicines and Replagal Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor if you use any medicines containing chloroquine, amiodarone, benoquin or gentamicin. There is a theoretical risk of decreased agalsidase alfa activity. Pregnancy and breast feeding Very limited clinical data on pregnancies exposed to Replagal have shown no adverse effects on the mother and newborn child. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines You may drive and use machines whilst on Replagal. Replagal contains sodium This medicine contains 14.2 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 0.7% of the recommended maximum daily dietary intake of sodium for an adult. Keeping a record In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded by your healthcare professional. Speak with your healthcare professional if you are not sure.</p></div>
</text>
</section>
<section>
<title value="3. How to take replagal"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="3. How to take replagal"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>This medicine should be applied and supervised by appropriately trained personnel, who will also calculate the dose that you will be given. While remaining under the physician s supervision, Replagal can be self-administered (by you or your caregiver) after appropriate training by the treating physician and/or nurse. Self-administration should occur in the presence of a responsible adult. The recommended dose is an infusion of 0.2 mg for every kg you weigh. This would be about 14 mg or 4 vials (glass bottles) of Replagal for an average size (70 kg) individual. Use in children and adolescents For children and adolescents 7-18 years old a dose of 0.2 mg/kg every other week may be used. Children and adolescents may be more likely than adults to experience an infusion related reaction. Tell your doctor if you experience any side effects whilst having the infusion. Method of administration Replagal has to be diluted in 9 mg/ml (0.9%) sodium chloride solution before use. After dilution Replagal is given in a vein. This will usually be in your arm. The infusion will be given every two weeks. Each time you are treated it will take 40 minutes for Replagal to be given to you in a vein. Your treatment will be supervised by a doctor who specialises in the treatment of Fabry Disease. For self-administration, the dose and rate of infusion given should not be changed without the agreement of the treating physician. If you use more Replagal than you should If you believe you have used more Replagal than you should, please contact your doctor. If you use less Replagal than you should If you believe you have used less Replagal than you should, please contact your doctor. If you forget to use Replagal If you have missed an infusion of Replagal, please contact your doctor. If you stop using Replagal Do not stop using Replagal without contacting your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.</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"><h2 id="like-all-medicines-this-medicine-can-cause-side-effects-although-not-everybody-gets-them-if-you-experience-a-severe-allergic-anaphylactic-type-reaction-the-administration-of-replagal-will-be-immediately-discontinued-and-an-appropriate-treatment-will-have-to-be-initiated-by-your-doctor-most-side-effects-are-mild-to-moderate-more-than-1-in-10-people-frequency-very-common--may-have-a-reaction-during-or-following-an-infusion-of-replagal-infusion-related-reaction-these-effects-include-chills-headache-nausea-fever-tiredness-unsteadiness-difficulty-breathing-shaking-cough-and-vomiting-however-some-effects-may-be-serious-and-may-need-treatment-infusion-related-reactions-involving-the-heart-including-heart-muscle-ischemia-and-heart-failure-may-occur-in-patients-with-fabry-disease-involving-the-heart-structures-frequency-not-known-cannot-be-estimated-from-the-available-data-your-doctor-may-stop-the-infusion-temporarily-5---10-min-until-the-symptoms-go-away-and-then-begin-the-infusion-again-your-doctor-may-also-treat-the-symptoms-with-other-medicines-antihistamines-or-corticosteroids-most-of-the-time-you-can-still-be-given-replagal-even-if-these-symptoms-occur-list-of-other-side-effects-very-common-may-affect-more-than-1-in-10-people">Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience a severe allergic (anaphylactic-type) reaction, the administration of Replagal will be immediately discontinued and an appropriate treatment will have to be initiated by your doctor. Most side effects are mild to moderate. More than 1 in 10 people (frequency very common ) may have a reaction during or following an infusion of Replagal (infusion related reaction). These effects include chills, headache, nausea, fever, tiredness, unsteadiness, difficulty breathing, shaking, cough and vomiting. However, some effects may be serious and may need treatment. Infusion related reactions involving the heart including heart muscle ischemia and heart failure, may occur in patients with Fabry disease involving the heart structures (frequency not known (cannot be estimated from the available data)). Your doctor may stop the infusion temporarily (5 - 10 min) until the symptoms go away and then begin the infusion again. Your doctor may also treat the symptoms with other medicines (antihistamines or corticosteroids). Most of the time you can still be given Replagal even if these symptoms occur. List of other side effects: Very common: may affect more than 1 in 10 people</h2><h2 id="swelling-in-the-tissue-eg-legs-arm">swelling in the tissue (e.g., legs, arm)</h2><h2 id="tingling-or-numbness-or-pain-in-fingers-or-toes">tingling or numbness or pain in fingers or toes</h2><h2 id="ear-ringing">ear ringing</h2><h2 id="palpitations">palpitations</h2><h2 id="sore-throat">Sore throat</h2><h2 id="abdominal-pain-diarrhoea">abdominal pain, diarrhoea</h2><h2 id="rash">rash</h2><h2 id="back-or-limb-pain-muscle-pain-joint-pain">back or limb pain, muscle pain, joint pain</h2><h2 id="chest-pain-cold-symptoms-fever-feeling-sick-common-may-affect-up-to-1-in-10-people">chest pain, cold symptoms, fever, feeling sick Common: may affect up to 1 in 10 people:</h2><h2 id="change-in-the-taste-of-food-prolonged-sleep">change in the taste of food, prolonged sleep</h2><h2 id="eyes-tearing">eyes tearing</h2><h2 id="increased-ear-ringing">increased ear ringing</h2><h2 id="increased-heart-rate-heart-rhythm-problems">increased heart rate, heart rhythm problems</h2><h2 id="increased-blood-pressure-low-blood-pressure-facial-flushing-redness">increased blood pressure, low blood pressure, facial flushing (redness)</h2><h2 id="hoarseness-or-tight-throat-runny-nose">hoarseness, or tight throat, runny nose</h2><h2 id="abdominal-discomfort">abdominal discomfort</h2><h2 id="acne-red-or-itchy-or-mottled-skin-excessive-sweating">acne, red or itchy or mottled skin, excessive sweating</h2><h2 id="muscle-and-bone-discomfort-swelling-of-the-extremities-or-joints">muscle and bone discomfort, swelling of the extremities or joints</h2><h2 id="hypersensitivity">hypersensitivity</h2><h2 id="chest-tightness-increased-feeling-lack-of-energy-feeling-cold-or-hot-flu-like-symptoms-discomfort-uncommon-may-affect-up-to-1-in-100-people">chest tightness, increased feeling lack of energy, feeling cold or hot, flu-like symptoms, discomfort Uncommon: may affect up to 1 in 100 people:</h2><h2 id="severe-allergic-anaphylactic-type-reaction">severe allergic (anaphylactic-type) reaction</h2><h2 id="blink-reflex-abnormal">blink reflex abnormal</h2><h2 id="increased-heart-rate">increased heart rate</h2><h2 id="low-level-of-oxygen-in-your-blood-and-sticky-throat-secretions">low level of oxygen in your blood and sticky throat secretions</h2><h2 id="sense-of-smell-is-different">sense of smell is different)</h2><h2 id="collection-of-fluid-under-the-skin-may-lead-to-swelling-of-body-parts-lace-like-discoloration-of-the-skin-eg-in-the-leg">collection of fluid under the skin may lead to swelling of body parts, lace-like discoloration of the skin e.g., in the leg</h2><h2 id="sensation-of-heaviness">sensation of heaviness</h2><p>injection site rash Children and adolescents Side effects reported in children were, in general, similar to those reported in adults. However, infusion related reactions (fever, difficulty breathing, chest pain) and pain aggravated occurred more frequently. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.</p></div>
</text>
</section>
<section>
<title value="5. How to store replagal"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="5. How to store replagal"/>
</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. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C 8 C). Do not use Replagal if you notice that there is discolouration or other foreign particles present. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.</p></div>
</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"><h2 id="what-replagal-contains">What Replagal contains</h2><h2 id="the-active-substance-is-agalsidase-alfa-each-ml-of-replagal-contains-1-mg-of-agalsidase-alfa">The active substance is agalsidase alfa. Each ml of Replagal contains 1 mg of agalsidase alfa.</h2><p>The other ingredients are: Sodium phosphate monobasic, monohydrate Polysorbate Sodium chloride Sodium hydroxide Water for injections Replagal contains sodium. See section 2. What Replagal looks like and contents of the pack Replagal is a concentrate for solution for infusion. Your medicine is available in vials containing 3.5 mg/ 3.5 ml of agalsidase alfa. Pack sizes of 1, 4 or 10 vials are available. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 58 Baggot Street Lower Dublin 2 D02 HWIreland Manufacturer Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 58 Baggot Street Lower Dublin D02 HWIreland Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza 50 58 Baggot Street Lower Dublin 2 Ireland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Takeda Belgium NV Tel/T l: +32 2 464 06 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a> Lietuva Takeda, UAB Tel: +370 521 09 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a></p><p>.: +359 2 958 27 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a> Luxembourg/Luxemburg Takeda Belgium NV Tel/T l: +32 2 464 06 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a> esk republika Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a> Magyarorsz g Takeda Pharma Kft. Tel: +36 1 270 <a href="mailto:7medinfoEMEA@takeda.com">7medinfoEMEA@takeda.com</a> Danmark Takeda Pharma A/S Tlf: +45 46 77 10 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a> Malta akeda HELLAS S.A. Tel: +30 210 <a href="mailto:6387medinfoEMEA@takeda.com">6387medinfoEMEA@takeda.com</a> Deutschland Takeda GmbH Tel: +49 (0)800 825 <a href="mailto:3medinfoEMEA@takeda.com">3medinfoEMEA@takeda.com</a> Nederland Takeda Nederland B.V. Tel: +31 20 203 <a href="mailto:5medinfoEMEA@takeda.com">5medinfoEMEA@takeda.com</a> Eesti Takeda Pharma AS Tel: +372 6177 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a> Norge Takeda AS Tlf: +47 800 800 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a></p><p>akeda . . T : +30 210 <a href="mailto:6387medinfoEMEA@takeda.com">6387medinfoEMEA@takeda.com</a> sterreich Takeda Pharma Ges.m.b.H. Tel: +43 (0) 800-20 80 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a> Espa a Takeda Farmac utica Espa a S.A Tel: +34 917 90 42 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a> Polska Takeda Pharma Sp. z o.o. Tel: <a href="mailto:+48223062medinfoEMEA@takeda.com">+48223062medinfoEMEA@takeda.com</a> France Takeda France SAS T l. + 33 1 40 67 33 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a> Portugal Takeda Farmac uticos Portugal, Lda. Tel: + 351 21 120 <a href="mailto:1medinfoEMEA@takeda.com">1medinfoEMEA@takeda.com</a> Hrvatska Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a> Rom nia Takeda Pharmaceuticals SRL Tel: +40 21 335 03 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a> Ireland Takeda Products Ireland Ltd Tel: 1800 937 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a> Slovenija Takeda Pharmaceuticals farmacevtska dru ba d.o.o. Tel: + 386 (0) 59 082 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a> sland Vistor hf. S mi: +354 535 <a href="mailto:7medinfoEMEA@takeda.com">7medinfoEMEA@takeda.com</a> Slovensk republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a> Italia Takeda Italia S.p.A. Tel: +39 06 <a href="mailto:502medinfoEMEA@takeda.com">502medinfoEMEA@takeda.com</a> Suomi/Finland Takeda Oy Puh/Tel: 0800 774 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a></p><p>akeda . . : +30 210 <a href="mailto:6387medinfoEMEA@takeda.com">6387medinfoEMEA@takeda.com</a> Sverige Takeda Pharma AB Tel: 020 795 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a> Latvija Takeda Latvia SIA Tel: +371 <a href="mailto:67840medinfoEMEA@takeda.com">67840medinfoEMEA@takeda.com</a> United Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 (0) 2830 640 <a href="mailto:medinfoEMEA@takeda.com">medinfoEMEA@takeda.com</a> 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>
</text>
</section>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl
value="MedicinalProductDefinition/mp82ed3b7e13571c65c8c961f4a21dd3e2"/>
<resource>
<MedicinalProductDefinition>
<id value="mp82ed3b7e13571c65c8c961f4a21dd3e2"/>
<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_mp82ed3b7e13571c65c8c961f4a21dd3e2"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mp82ed3b7e13571c65c8c961f4a21dd3e2</b></p><a name="mp82ed3b7e13571c65c8c961f4a21dd3e2"> </a><a name="hcmp82ed3b7e13571c65c8c961f4a21dd3e2"> </a><a name="mp82ed3b7e13571c65c8c961f4a21dd3e2-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/01/189/001-003</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>: Replagal 1 mg/ml concentrate for solution for infusion.</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/1/01/189/001-003"/>
</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="Replagal 1 mg/ml concentrate for solution for infusion."/>
<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.
