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/hl7-eu/gravitate-health/ and changes regularly. See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
<id value="enhanced-bundleflucelvax-pedro"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"/>
</meta>
<language value="en"/>
<identifier>
<system value="https://www.gravitatehealth.eu/sid/doc"/>
<value value="EU/1/97/049/001"/>
</identifier>
<type value="document"/>
<timestamp value="2023-04-25T11:55:27Z"/>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Composition/enhanced-composition056f32ee5cf49404607e368bd8d3f2afg"/>
<resource>
<Composition>
<id value="enhanced-composition056f32ee5cf49404607e368bd8d3f2afg"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><a name="Composition_enhanced-composition056f32ee5cf49404607e368bd8d3f2afg"> </a><p class="res-header-id"><b>Generated Narrative: Composition enhanced-composition056f32ee5cf49404607e368bd8d3f2afg</b></p><a name="enhanced-composition056f32ee5cf49404607e368bd8d3f2afg"> </a><a name="hcenhanced-composition056f32ee5cf49404607e368bd8d3f2afg"> </a><a name="enhanced-composition056f32ee5cf49404607e368bd8d3f2afg-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>eu/fhir/ig/gravitate-health/StructureDefinition/Lenses</b>: <code>mock-lib</code></p><blockquote><p><b>HtmlElementLink</b></p><ul><li>elementClass: pregnancyCategory</li><li>concept: <span title="Codes:{http://snomed.info/sct 77386006}">Pregnancy</span></li></ul></blockquote><p><b>identifier</b>: <code>https://spor.ema.europa.eu/rmswi/</code>/asdasd</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 F}">Focused</span></p><p><b>date</b>: 2023-04-22 15:15:46+0000</p><p><b>author</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>title</b>: TEST PURPOSES ONLY - asdad</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>2023-04-22 15:15:46+0000</td></tr></table></div>
</text>
<extension
url="http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/Lenses">
<valueReference>
<reference value="mock-lib"/>
</valueReference>
</extension>
<extension
url="http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink">
<extension url="elementClass">
<valueString value="pregnancyCategory"/>
</extension>
<extension url="concept">
<valueCodeableReference>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="77386006"/>
<display value="Pregnancy"/>
</coding>
</concept>
</valueCodeableReference>
</extension>
</extension>
<identifier>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<value value="asdasd"/>
</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="F"/>
<display value="Focused"/>
</coding>
</category>
<subject>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</subject>
<date value="2023-04-22T15:15:46Z"/>
<author>
<reference
value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
</author>
<title value="TEST PURPOSES ONLY - asdad"/>
<attester>
<mode>
<coding>
<system
value="http://hl7.org/fhir/composition-attestation-mode"/>
<code value="official"/>
</coding>
</mode>
<time value="2023-04-22T15:15:46Z"/>
</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"><div xmlns="http://www.w3.org/1999/xhtml"><p class="MsoNormal" align="center"><strong><span lang="EN-GB">Package leaflet: Information for the user</span></strong></p> <p class="MsoNormal" align="center"><span lang="EN-GB"> </span></p> <p class="SmPC-PLtext" align="center"><strong><span>Flucelvax Tetra</span></strong><strong><span lang="EN-GB"> - suspension for injection in pre-filled syringe</span></strong></p> <p class="SmPC-PLtext" align="center"><span lang="EN-GB">Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)</span></p> <p class="MsoNormal"><span lang="EN-GB"> </span></p> <p class="MsoNormal"><span lang="EN-GB"><img src="data:image/png;base64,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" annotationsrc="~/_entity/annotation/76a10366-26e0-ed11-a7c6-000d3aaa0403" />This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.</span></p> <p class="MsoNormal"><strong><span lang="EN-GB"> </span></strong></p> <p class="MsoNormal"><strong><span lang="EN-GB">Read all of this leaflet carefully before you receive this medicine because it contains important information for you.</span></strong></p> <p class="MsoNormal"><!-- [if !supportLists]--><span lang="EN-GB"><span>-<span>              </span></span></span><!--[endif]--><span lang="EN-GB">Keep this leaflet. You may need to read it again. </span></p> <p class="MsoNormal"><!-- [if !supportLists]--><span lang="EN-GB"><span>-<span>              </span></span></span><!--[endif]--><span lang="EN-GB">If you have any further questions, ask your doctor, pharmacist or nurse.</span></p> <p class="MsoNormal"><!-- [if !supportLists]--><span lang="EN-GB"><span>-<span>              </span></span></span><!--[endif]--><span lang="EN-GB">If you get any side effects, talk to your doctor, pharmacist or nurse.</span><span lang="EN-GB"> </span><span lang="EN-GB">This includes any possible side effects not listed in this leaflet. See section 4.</span></p> <p class="MsoNormal"><span lang="EN-GB"> </span></p> <p class="MsoNormal"><span lang="EN-GB"> </span></p> <p class="MsoNormal"><strong><span lang="EN-GB">What is in this leaflet</span></strong></p> <p class="MsoNormal"><span lang="EN-GB"> </span></p> <p class="MsoNormal"><span lang="EN-GB">1.<span>    </span>What </span><span>Flucelvax Tetra </span><span lang="EN-GB">is and what it is used for </span></p> <p class="MsoNormal"><span lang="EN-GB">2.<span>    </span>What you need to know before you <span class="SmPC-PLtextChar">receive </span></span><span>Flucelvax Tetra</span><span> </span></p> <p class="MsoNormal"><span lang="EN-GB">3.<span>    </span>How </span><span>Flucelvax Tetra </span><span class="SmPC-PLtextChar"><span lang="EN-GB">is given</span></span><span lang="EN-GB"> </span></p> <p class="MsoNormal"><span lang="EN-GB">4.<span>    </span>Possible side effects </span></p> <p class="MsoNormal"><span lang="EN-GB">5.<span>    </span>How to store </span><span>Flucelvax Tetra </span><span><span> </span></span></p> <p class="MsoNormal"><span lang="EN-GB">6.<span>    </span>Contents of the pack and other information</span></p></div></div>
</text>
<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">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</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">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
</section>
<section>
<title value="1. What asdad 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 asdad is and what it is used for"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"><p class="SmPC-PLtext"><span>Flucelvax Tetra</span><span> </span><span lang="EN-GB">is a vaccine against flu (influenza). </span><span>Flucelvax Tetra</span><span> </span><span class="SmPC-PLtextChar"><span lang="EN-GB">is prepared in cell cultures, and, therefore, is egg-free.</span></span></p> <p class="SmPC-PLtext"><span lang="EN-GB">When a person is given the vaccine, the immune system (the body’s natural defence system) will produce its own protection against the influenza virus. None of the ingredients in the vaccine can cause flu.</span></p> <p class="SmPC-PLtext"><span lang="EN-GB"> </span></p> <p class="SmPC-PLtext"><span>Flucelvax Tetra</span><span> </span><span lang="EN-GB">is used to prevent flu in adults and children from 2 years of age.</span></p> <p class="SmPC-PLtext"><span lang="EN-GB"> </span></p> <p class="SmPC-PLtext"><span lang="EN-GB">The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2022/2023 SEASON.</span></p></div></div>
</text>
</section>
<section>
<title value="2. What you need to know before you take asdad"/>
<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 asdad"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"><p class="SmPC-PLtext"><span lang="EN-GB">If you are allergic to:</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>·<span>        </span></span></span><!--[endif]--><span lang="EN-GB">the active ingredients or any of the other ingredients of this medicine (listed in section 6)</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>·<span>        </span></span></span><!--[endif]--><span lang="EN-GB">beta-propiolactone, cetyltrimethylammonium bromide, or polysorbate 80, which are trace residues from the manufacturing process.</span></p></div></div>
</text>
</section>
<section>
<title value="3. How to take asdad"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="3. How to take asdad"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"><p class="MsoNormal"><span lang="EN-GB">Talk to your doctor, pharmacist or nurse before <span class="SmPC-PLtextChar">receiving</span> </span><span>Flucelvax Tetra</span><span class="SmPC-PLtextChar"><span lang="EN-GB">.</span></span></p> <p class="MsoNormal"><span lang="EN-GB"> </span><u><span>BEFORE receiving the vaccine</span></u></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span><span>·<span>        </span></span></span><!--[endif]--><span>Your <span>doctor or nurse</span> will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration. This reaction may occur with </span><span>Flucelvax Tetra</span><span class="SmPC-PLtextChar"><span> </span></span><span>as with all vaccines that are injected.</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span><span>·<span>        </span></span></span><!--[endif]--><span>You should tell your doctor if you have an acute illness associated with fever. Your doctor may decide to delay your vaccination until your fever is gone.</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span><span>·<span>        </span></span></span><!--[endif]--><span>You</span><span> should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see section “Other medicines and Flucelvax Tetra”).</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span><span>·<span>        </span></span></span><!--[endif]--><span>You should tell your doctor if you have a bleeding problem or bruise easily.</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span><span>·<span>        </span></span></span><!--[endif]--><span>Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection.</span></p> <p class="SmPC-PLtext"><span> </span><span>As with all vaccines, Flucelvax Tetra may not fully protect all persons who are vaccinated.</span></p></div></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"><div xmlns="http://www.w3.org/1999/xhtml"><p class="MsoNormal"><span lang="EN-GB">Like all medicines, this medicine can cause side effects, although not everybody gets them.</span></p> <p class="SmPC-PLtext"><span lang="EN-GB">The following side effects have been reported during clinical trials and during general use:</span></p> <p class="SmPC-PLtext"><span lang="EN-GB"> </span></p> <p class="SmPC-PLtext"><strong><span lang="EN-GB">Very serious side effects</span></strong></p> <p class="SmPC-PLtext"><span lang="EN-GB">Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect – you may need urgent medical attention or hospitalisation:</span></p> <p class="SmPC-PLtext"><span lang="EN-GB"> </span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">Difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction)</span></p> <p class="SmPC-PLtext"><span lang="EN-GB"> </span></p> <p class="SmPC-PLtext"><strong><span lang="EN-GB">Serious side effects</span></strong></p> <p class="SmPC-PLtext"><span lang="EN-GB">Tell your doctor immediately if you experience any of the following side effects – you may need medical attention:</span></p> <p class="SmPC-PLtext"><span lang="EN-GB"> </span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">You feel weak, you have difficulty moving around or you experience numbness or tingling in your limbs. These can be symptoms of <span> </span>Guillain-Barré syndrome (GBS), an autoimmune disease caused by your body’s own immune system.</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">Extensive swelling of injected limb</span></p> <p class="SmPC-PLtext"><span lang="EN-GB"> </span></p> <p class="SmPC-PLtext"><strong><span lang="EN-GB">Mild side effects</span></strong></p> <p class="SmPC-PLtext"><u><span lang="EN-GB">Very common</span></u><span lang="EN-GB"> (may affect more than 1 in 10 people):</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">Injection site pain, bruising, reddening and hardening or swelling at the site of the injection</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">Headache</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">Muscle pain <span> </span></span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">Tiredness </span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">Loss of appetite</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">Irritability (only reported in children from 2 to < 6 years)</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">Sleepiness (only reported in children 2 to < 6 years)</span></p> <p class="SmPC-PLtext"><span lang="EN-GB">Hardening or swelling at the site of the injection, headache, muscle pain, and tiredness were common in the elderly.</span></p> <p class="SmPC-PLtext"><span lang="EN-GB">Bruising at the site of the injection was common in adults, eldery and children 9 to < 18 years.</span></p> <p class="SmPC-PLtext"><span lang="EN-GB">Headache was common in the elderly.</span></p> <p class="SmPC-PLtext"><span lang="EN-GB">Loss of appetite was common in adults, eldery and children 9 to < 18 years.</span></p> <p class="SmPC-PLtext"><span lang="EN-GB"> </span></p> <p class="SmPC-PLtext"><u><span lang="EN-GB">Common</span></u><span lang="EN-GB"> (may affect up to 1 in 10 people):</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">Nausea, vomiting, diarrhoea </span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">Joint pain</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">Shivering</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">Change in eating habits (only reported in children from 2 to < 6 years)</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">Fever (<u>></u> 38°C)</span></p> <p class="SmPC-PLtext"><span lang="EN-GB">Vomiting was uncommon in the elderly.</span></p> <p class="SmPC-PLtext"><span lang="EN-GB">Fever was uncommon in adults and the elderly.</span></p> <p class="SmPC-PLtext"><span lang="EN-GB"> </span></p> <p class="SmPC-PLtext"><u><span lang="EN-GB">Not known</span></u><span lang="EN-GB"> (frequency cannot be estimated from the available data):</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">Numbness and tingling sensation (paraesthesia)</span></p> <p class="SmPC-PLtext"><!-- [if !supportLists]--><span lang="EN-GB"><span>•<span>      </span></span></span><!--[endif]--><span lang="EN-GB">Generalised skin reactions including itching, bumps on the skin (pruritis, urticaria) or non-specific rash </span></p></div></div>
</text>
</section>
<section>
<title value="5. How to store asdad"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="5. How to store asdad"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"><p class="MsoNormal"><span lang="EN-GB">Keep this <span class="SmPC-PLtextChar">vaccine</span> out of the sight and reach of children.</span></p> <p class="MsoNormal"><span lang="EN-GB"> </span></p> <p class="SmPC-PLtext"><span lang="EN-GB">Store in a refrigerator (2 °C to 8 °C). Do not freeze.</span></p> <p class="SmPC-PLtext"><span lang="EN-GB">Keep the pre-filled syringe in the outer carton in order to protect from light.</span></p> <p class="MsoNormal"><span lang="EN-GB"> </span></p> <p class="MsoNormal"><span lang="EN-GB">Do not use this <span class="SmPC-PLtextChar">vaccine</span> after the expiry date which is stated on the label and carton after <span class="SmPC-PLtextChar">EXP</span>. The expiry date refers to the last day of that month.</span></p> <p class="MsoNormal"><span lang="EN-GB"> </span></p> <p class="MsoNormal"><span lang="EN-GB">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.</span></p></div></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"><div xmlns="http://www.w3.org/1999/xhtml"><p class="SmPC-PLtext"><span>Flucelvax Tetra</span><span> </span><span lang="EN-GB">is a suspension for injection in a pre-filled syringe (ready to use syringe). <br /></span><span>Flucelvax Tetra</span><span> </span><span lang="EN-GB">is a clear to slightly opalescent suspension.</span></p> <p class="SmPC-PLtext"><span lang="EN-GB">A single syringe contains 0.5 ml of suspension for injection.</span></p> <p class="SmPC-PLtext"><span>Flucelvax Tetra</span><span> </span><span lang="EN-GB">is available in packs containing 1 pre-filled syringe with or without needle or 10 pre-filled syringes with or without needles.</span></p> <p class="SmPC-PLtext"><span lang="EN-GB">Not all pack sizes may be marketed.</span></p></div></div>
</text>
</section>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-2e8cb2387c664fb619f6b8914767d38f"/>
<resource>
<Ingredient>
<id value="ingredient-for-2e8cb2387c664fb619f6b8914767d38f"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-2e8cb2387c664fb619f6b8914767d38f"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-2e8cb2387c664fb619f6b8914767d38f</b></p><a name="ingredient-for-2e8cb2387c664fb619f6b8914767d38f"> </a><a name="hcingredient-for-2e8cb2387c664fb619f6b8914767d38f"> </a><a name="ingredient-for-2e8cb2387c664fb619f6b8914767d38f-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/9V4SVN4JQV (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072072}">active</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 9V4SVN4JQV}">INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style="display: none">*</td><td>15 ug<span style="background: LightGoldenRodYellow"> (Details: UCUM codeug = 'ug')</span></td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}">active ingredient - basis of strength</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="9V4SVN4JQV"/>
</identifier>
<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072072"/>
<display value="active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="9V4SVN4JQV"/>
<display
value="INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE"/>
</coding>
</concept>
</code>
<strength>
<presentationQuantity>
<value value="15"/>
<system value="http://unitsofmeasure.org"/>
<code value="ug"/>
</presentationQuantity>
<basis>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="ACTIB"/>
<display value="active ingredient - basis of strength"/>
</coding>
</basis>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole"/>
<resource>
<Ingredient>
<id
value="ingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole</b></p><a name="ingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole"> </a><a name="hcingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole"> </a><a name="ingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/JS7E5ZZ3AC (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">active</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta JS7E5ZZ3AC}">INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style="display: none">*</td><td>15 ug<span style="background: LightGoldenRodYellow"> (Details: UCUM codeug = 'ug')</span></td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}">active ingredient - basis of strength</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="JS7E5ZZ3AC"/>
</identifier>
<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="JS7E5ZZ3AC"/>
<display
value="INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE"/>
</coding>
</concept>
</code>
<strength>
<presentationQuantity>
<value value="15"/>
<system value="http://unitsofmeasure.org"/>
<code value="ug"/>
</presentationQuantity>
<basis>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="ACTIB"/>
<display value="active ingredient - basis of strength"/>
</coding>
</basis>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-f4e520e2974f4acb8abe26b607ea5a46"/>
<resource>
<Ingredient>
<id value="ingredient-for-f4e520e2974f4acb8abe26b607ea5a46"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-f4e520e2974f4acb8abe26b607ea5a46"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-f4e520e2974f4acb8abe26b607ea5a46</b></p><a name="ingredient-for-f4e520e2974f4acb8abe26b607ea5a46"> </a><a name="hcingredient-for-f4e520e2974f4acb8abe26b607ea5a46"> </a><a name="ingredient-for-f4e520e2974f4acb8abe26b607ea5a46-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/BFA4LSE5QQ (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">active</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta BFA4LSE5QQ}">INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style="display: none">*</td><td>15 ug<span style="background: LightGoldenRodYellow"> (Details: UCUM codeug = 'ug')</span></td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}">active ingredient - basis of strength</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="BFA4LSE5QQ"/>
</identifier>
<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="BFA4LSE5QQ"/>
<display
value="INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE"/>
</coding>
</concept>
</code>
<strength>
<presentationQuantity>
<value value="15"/>
<system value="http://unitsofmeasure.org"/>
<code value="ug"/>
</presentationQuantity>
<basis>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="ACTIB"/>
<display value="active ingredient - basis of strength"/>
</coding>
</basis>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-2c0c197a41a706fb2549601e635da1f3"/>
<resource>
<Ingredient>
<id value="ingredient-for-2c0c197a41a706fb2549601e635da1f3"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-2c0c197a41a706fb2549601e635da1f3"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-2c0c197a41a706fb2549601e635da1f3</b></p><a name="ingredient-for-2c0c197a41a706fb2549601e635da1f3"> </a><a name="hcingredient-for-2c0c197a41a706fb2549601e635da1f3"> </a><a name="ingredient-for-2c0c197a41a706fb2549601e635da1f3-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/B3EV5T8SUF (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">active</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta B3EV5T8SUF}">INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style="display: none">*</td><td>15 ug<span style="background: LightGoldenRodYellow"> (Details: UCUM codeug = 'ug')</span></td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}">active ingredient - basis of strength</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="B3EV5T8SUF"/>
</identifier>
<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="B3EV5T8SUF"/>
<display
value="INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE"/>
</coding>
</concept>
</code>
<strength>
<presentationQuantity>
<value value="15"/>
<system value="http://unitsofmeasure.org"/>
<code value="ug"/>
</presentationQuantity>
<basis>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="ACTIB"/>
<display value="active ingredient - basis of strength"/>
</coding>
</basis>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-sodiumchloride"/>
<resource>
<Ingredient>
<id value="ingredient-for-flucelvax-sodiumchloride"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-flucelvax-sodiumchloride"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-flucelvax-sodiumchloride</b></p><a name="ingredient-for-flucelvax-sodiumchloride"> </a><a name="hcingredient-for-flucelvax-sodiumchloride"> </a><a name="ingredient-for-flucelvax-sodiumchloride-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/451W47IQ8X (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 451W47IQ8X}">Sodium chloride</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="451W47IQ8X"/>
</identifier>
<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="451W47IQ8X"/>
<display value="Sodium chloride"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-potassiumchloride"/>
<resource>
<Ingredient>
<id value="ingredient-for-flucelvax-potassiumchloride"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-flucelvax-potassiumchloride"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-flucelvax-potassiumchloride</b></p><a name="ingredient-for-flucelvax-potassiumchloride"> </a><a name="hcingredient-for-flucelvax-potassiumchloride"> </a><a name="ingredient-for-flucelvax-potassiumchloride-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/660YQ98I10 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 660YQ98I10}">Potassium chloride</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="660YQ98I10"/>
</identifier>
<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="660YQ98I10"/>
<display value="Potassium chloride"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-magnesiumchloride"/>
<resource>
<Ingredient>
<id value="ingredient-for-flucelvax-magnesiumchloride"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-flucelvax-magnesiumchloride"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-flucelvax-magnesiumchloride</b></p><a name="ingredient-for-flucelvax-magnesiumchloride"> </a><a name="hcingredient-for-flucelvax-magnesiumchloride"> </a><a name="ingredient-for-flucelvax-magnesiumchloride-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/02F3473H9O (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 02F3473H9O}">MAGNESIUM CHLORIDE</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="02F3473H9O"/>
</identifier>
<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="02F3473H9O"/>
<display value="MAGNESIUM CHLORIDE"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate"/>
<resource>
<Ingredient>
<id value="ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate</b></p><a name="ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate"> </a><a name="hcingredient-for-flucelvax-sodiumphosphatedibasicdihydrate"> </a><a name="ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/94255I6E2T (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 94255I6E2T}">SODIUM PHOSPHATE, DIBASIC, DIHYDRATE</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="94255I6E2T"/>
</identifier>
<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="94255I6E2T"/>
<display value="SODIUM PHOSPHATE, DIBASIC, DIHYDRATE"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-potassiumdihydrogenphosphate"/>
<resource>
<Ingredient>
<id value="ingredient-for-flucelvax-potassiumdihydrogenphosphate"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-flucelvax-potassiumdihydrogenphosphate"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-flucelvax-potassiumdihydrogenphosphate</b></p><a name="ingredient-for-flucelvax-potassiumdihydrogenphosphate"> </a><a name="hcingredient-for-flucelvax-potassiumdihydrogenphosphate"> </a><a name="ingredient-for-flucelvax-potassiumdihydrogenphosphate-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/4J9FJ0HL51 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 4J9FJ0HL51}">Potassium dihydrogen phosphate</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="4J9FJ0HL51"/>
</identifier>
<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="4J9FJ0HL51"/>
<display value="Potassium dihydrogen phosphate"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-waterforinjections"/>
<resource>
<Ingredient>
<id value="ingredient-for-flucelvax-waterforinjections"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-for-flucelvax-waterforinjections"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-for-flucelvax-waterforinjections</b></p><a name="ingredient-for-flucelvax-waterforinjections"> </a><a name="hcingredient-for-flucelvax-waterforinjections"> </a><a name="ingredient-for-flucelvax-waterforinjections-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/059QF0KO0R (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 059QF0KO0R}">Water for injections</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="059QF0KO0R"/>
</identifier>
<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="059QF0KO0R"/>
<display value="Water for injections"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzaavirusadelaware552019cvr45h1n1whole"/>
<resource>
<SubstanceDefinition>
<id value="substance-influenzaavirusadelaware552019cvr45h1n1whole"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_substance-influenzaavirusadelaware552019cvr45h1n1whole"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition substance-influenzaavirusadelaware552019cvr45h1n1whole</b></p><a name="substance-influenzaavirusadelaware552019cvr45h1n1whole"> </a><a name="hcsubstance-influenzaavirusadelaware552019cvr45h1n1whole"> </a><a name="substance-influenzaavirusadelaware552019cvr45h1n1whole-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/9V4SVN4JQV (use: official, )</p><p><b>version</b>: 1.0</p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>manufacturer</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="9V4SVN4JQV"/>
</identifier>
<version value="1.0"/>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
</coding>
</status>
<manufacturer>
<reference
value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
</manufacturer>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzaavirusadarwin112021h3n2whole"/>
<resource>
<SubstanceDefinition>
<id value="substance-influenzaavirusadarwin112021h3n2whole"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_substance-influenzaavirusadarwin112021h3n2whole"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition substance-influenzaavirusadarwin112021h3n2whole</b></p><a name="substance-influenzaavirusadarwin112021h3n2whole"> </a><a name="hcsubstance-influenzaavirusadarwin112021h3n2whole"> </a><a name="substance-influenzaavirusadarwin112021h3n2whole-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/JS7E5ZZ3AC (use: official, )</p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>manufacturer</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="JS7E5ZZ3AC"/>
</identifier>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
</coding>
</status>
<manufacturer>
<reference
value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
</manufacturer>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzabvirusbsingaporewuh46182021whole"/>
<resource>
<SubstanceDefinition>
<id value="substance-influenzabvirusbsingaporewuh46182021whole"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_substance-influenzabvirusbsingaporewuh46182021whole"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition substance-influenzabvirusbsingaporewuh46182021whole</b></p><a name="substance-influenzabvirusbsingaporewuh46182021whole"> </a><a name="hcsubstance-influenzabvirusbsingaporewuh46182021whole"> </a><a name="substance-influenzabvirusbsingaporewuh46182021whole-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/BFA4LSE5QQ (use: official, )</p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>manufacturer</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="BFA4LSE5QQ"/>
</identifier>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
</coding>
</status>
<manufacturer>
<reference
value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
</manufacturer>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzabvirusbsingaporeinftt1606102016whole"/>
<resource>
<SubstanceDefinition>
<id value="substance-influenzabvirusbsingaporeinftt1606102016whole"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_substance-influenzabvirusbsingaporeinftt1606102016whole"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition substance-influenzabvirusbsingaporeinftt1606102016whole</b></p><a name="substance-influenzabvirusbsingaporeinftt1606102016whole"> </a><a name="hcsubstance-influenzabvirusbsingaporeinftt1606102016whole"> </a><a name="substance-influenzabvirusbsingaporeinftt1606102016whole-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/B3EV5T8SUF (use: official, )</p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>manufacturer</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="B3EV5T8SUF"/>
</identifier>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
</coding>
</status>
<manufacturer>
<reference
value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
</manufacturer>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
<resource>
<AdministrableProductDefinition>
<id value="ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition ap-04c9bd6fb89d38b2d83eced2460c4dc1</b></p><a name="ap-04c9bd6fb89d38b2d83eced2460c4dc1"> </a><a name="hcap-04c9bd6fb89d38b2d83eced2460c4dc1"> </a><a name="ap-04c9bd6fb89d38b2d83eced2460c4dc1-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/xx</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000074063}">suspension for injection in pre-filled syringe</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 200000002150}">Syringe</span></p><p><b>producedFrom</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073633}">Subcutaneous use</span></p><h3>TargetSpecies</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/rmswi 100000109093}">Human</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="xx"/>
</identifier>
<status value="active"/>
<formOf>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000074063"/>
<display value="suspension for injection in pre-filled syringe"/>
</coding>
</administrableDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000002150"/>
<display value="Syringe"/>
</coding>
</unitOfPresentation>
<producedFrom>
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</producedFrom>
<routeOfAdministration>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073633"/>
<display value="Subcutaneous use"/>
</coding>
</code>
<targetSpecies>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000109093"/>
<display value="Human"/>
</coding>
</code>
</targetSpecies>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization04c9bd6fb89d38b2d83eced2460c4dc10"/>
<resource>
<RegulatedAuthorization>
<id value="authorization04c9bd6fb89d38b2d83eced2460c4dc10"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_authorization04c9bd6fb89d38b2d83eced2460c4dc10"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization authorization04c9bd6fb89d38b2d83eced2460c4dc10</b></p><a name="authorization04c9bd6fb89d38b2d83eced2460c4dc10"> </a><a name="hcauthorization04c9bd6fb89d38b2d83eced2460c4dc10"> </a><a name="authorization04c9bd6fb89d38b2d83eced2460c4dc10-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/18/1326/001 (use: official, )</p><p><b>subject</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072062}">Marketing Authorisation</span></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>statusDate</b>: 2019-01-01</p><p><b>holder</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="EU/1/18/1326/001"/>
</identifier>
<subject>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</subject>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072062"/>
<display value="Marketing Authorisation"/>
</coding>
</type>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<statusDate value="2019-01-01"/>
<holder>
<reference
value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
</holder>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
<resource>
<Organization>
<id value="mah-45fe50eae508b5755dd140ab2093eb5e"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_mah-45fe50eae508b5755dd140ab2093eb5e"> </a><p class="res-header-id"><b>Generated Narrative: Organization mah-45fe50eae508b5755dd140ab2093eb5e</b></p><a name="mah-45fe50eae508b5755dd140ab2093eb5e"> </a><a name="hcmah-45fe50eae508b5755dd140ab2093eb5e"> </a><a name="mah-45fe50eae508b5755dd140ab2093eb5e-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/ORG-100013715 (use: official, )</p><p><b>active</b>: true</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 220000000034}">Marketing authorisation holder</span></p><p><b>name</b>: Seqirus Netherlands B.V.</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>Paasheuvelweg 28 1105BJ Amsterdam Netherlands(work)</td></tr></table></div>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/omswi"/>
<value value="ORG-100013715"/>
</identifier>
<active value="true"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="220000000034"/>
<display value="Marketing authorisation holder"/>
</coding>
</type>
<name value="Seqirus Netherlands B.V."/>
<contact>
<address>
<use value="work"/>
<type value="physical"/>
<text value="Paasheuvelweg 28 1105BJ Amsterdam Netherlands"/>
<line value="Paasheuvelweg 28"/>
<city value="1105BJ Amsterdam"/>
<postalCode value="367061"/>
<country value="Netherlands"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-a854b6fee6a8536c78c604a4b9f6c395"/>
<resource>
<PackagedProductDefinition>
<id value="ppd-a854b6fee6a8536c78c604a4b9f6c395"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_ppd-a854b6fee6a8536c78c604a4b9f6c395"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition ppd-a854b6fee6a8536c78c604a4b9f6c395</b></p><a name="ppd-a854b6fee6a8536c78c604a4b9f6c395"> </a><a name="hcppd-a854b6fee6a8536c78c604a4b9f6c395"> </a><a name="ppd-a854b6fee6a8536c78c604a4b9f6c395-en-US"> </a><p><b>name</b>: Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 1</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000155527}">100000155527</span></p><p><b>packageFor</b>: <a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>statusDate</b>: 2019-01-01</p><p><b>containedItemQuantity</b>: 15 ug<span style="background: LightGoldenRodYellow"> (Details: UCUM codeug = 'ug')</span></p><p><b>copackagedIndicator</b>: true</p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073498}">Box</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 200000003529}">Cardboard</span></p><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/xxxx</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073498}">100000073498</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 200000003529}">Cardboard</span></p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-bundlepackageleaflet-en-04c9bd6fb89d38b2d83eced2460c4dc1.html#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#EU/1/18/1326/001; type = document; timestamp = 2023-06-27 10:09:22+0000</a></td></tr></table></blockquote></blockquote></blockquote></div>
</text>
<name
value="Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 1"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000155527"/>
</coding>
</type>
<packageFor>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</packageFor>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<statusDate value="2019-01-01"/>
<containedItemQuantity>
<value value="15"/>
<system value="http://unitsofmeasure.org"/>
<code value="ug"/>
</containedItemQuantity>
<copackagedIndicator value="true"/>
<packaging>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000003529"/>
<display value="Cardboard"/>
</coding>
</material>
<packaging>
<identifier>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="xxxx"/>
</identifier>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073498"/>
<display value="100000073498"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000003529"/>
<display value="Cardboard"/>
</coding>
</material>
<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</reference>
</item>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
<resource>
<MedicinalProductDefinition>
<id value="mpb6ced64d25ea2c8da6c6099386f14db1"/>
<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_mpb6ced64d25ea2c8da6c6099386f14db1"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mpb6ced64d25ea2c8da6c6099386f14db1</b></p><a name="mpb6ced64d25ea2c8da6c6099386f14db1"> </a><a name="hcmpb6ced64d25ea2c8da6c6099386f14db1"> </a><a name="mpb6ced64d25ea2c8da6c6099386f14db1-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/18/1326/001, <code>https://www.who-umc.org/phpid</code>/0xF79CABF272B6A7EEF104DDDA44E82717</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 100000000000}">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)</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>: Flucelvax Tetra</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>: Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)</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>: 15 ug</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>: Solution for injection</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 ES}">Spain</span></td><td><span title="Codes:{urn:iso:std:iso:3166 ES}">Spain</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">English</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="EU/1/18/1326/001"/>
</identifier>
<identifier>
<system value="https://www.who-umc.org/phpid"/>
<value value="0xF79CABF272B6A7EEF104DDDA44E82717"/>
</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="100000000000"/>
<display
value="Medicinal product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<name>
<productName
value="Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000001"/>
<display value="Full name"/>
</coding>
</type>
<part>
<part value="Flucelvax Tetra"/>
<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="Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)"/>
<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="15 ug"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="Solution for injection"/>
<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="ES"/>
<display value="Spain"/>
</coding>
</country>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="ES"/>
<display value="Spain"/>
</coding>
</jurisdiction>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="en"/>
<display value="English"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
<resource>
<ManufacturedItemDefinition>
<id value="mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition mid-04c9bd6fb89d38b2d83eced2460c4dc1</b></p><a name="mid-04c9bd6fb89d38b2d83eced2460c4dc1"> </a><a name="hcmid-04c9bd6fb89d38b2d83eced2460c4dc1"> </a><a name="mid-04c9bd6fb89d38b2d83eced2460c4dc1-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/18/1326/001 (use: official, )</p><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi/ 100000074063}">suspension for injection in pre-filled syringe</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 200000002150}">Syringe</span></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="EU/1/18/1326/001"/>
</identifier>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000074063"/>
<display value="suspension for injection in pre-filled syringe"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000002150"/>
<display value="Syringe"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
</entry>
</Bundle>