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/hl7-eu/gravitate-health/ and changes regularly. See the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml"><p><strong>Read all of this leaflet carefully before you receive this medicine because it contains important information for you.</strong></p><ul><li>Keep this leaflet. You may need to read it again.</li><li>If you have any further questions, ask your doctor, pharmacist or nurse.</li><li>If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.</li></ul></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What is in this leaflet</p><ol><li>What Flucelvax Tetra is and what it is used for</li><li>What you need to know before you receive Flucelvax Tetra</li><li>How Flucelvax Tetra is given</li><li>Possible side effects</li><li>How to store Flucelvax Tetra</li><li>Contents of the pack and other information</li></ol></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Flucelvax Tetra is a vaccine against flu (influenza). Flucelvax Tetra is prepared in cell cultures, and, therefore, is egg-free.</p><p>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.</p><p>Flucelvax Tetra is used to prevent flu in adults and children from 2 years of age.</p><p>The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2022/2023 SEASON.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p><strong>You should not receive Flucelvax Tetra:</strong></p><p>If you are allergic to:</p><ul><li>the active ingredients or any of the other ingredients of this medicine (listed in section 6)</li><li>beta-propiolactone, cetyltrimethylammonium bromide, or polysorbate 80, which are trace residues from the manufacturing process.</li></ul><p><strong>Warnings and precautions</strong></p><p>Talk to your doctor, pharmacist or nurse before receiving Flucelvax Tetra.</p><p><em>BEFORE receiving the vaccine</em>.</p><ul><li>Your doctor or nurse 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 Flucelvax Tetra as with all vaccines that are injected.</li><li>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.</li><li>You 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”).</li><li>You should tell your doctor if you have a bleeding problem or bruise easily.</li><li>Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection.</li></ul><p>As with all vaccines, Flucelvax Tetra may not fully protect all persons who are vaccinated.</p><p><strong>Other medicines and Flucelvax Tetra</strong></p><p>Tell your doctor or nurse if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription or if you have recently received any other vaccine. Flucelvax Tetra may be given at the same time as other vaccines.</p><p><strong>Pregnancy and breast-feeding</strong></p><div class="pregnancyCategory"><p><strong>Pregnancy and breast-feeding</strong></p><p><strong>Pregnancy:</strong></p><p>Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. Influenza vaccines may be given in any trimester of pregnancy.</p></div><p><strong>Breast-feeding:</strong></p><p>Use of Flucelvax Tetra during breast-feeding has not been studied. Flucelvax Tetra may be given during breast-feeding.</p><p><strong>Driving and using machines</strong></p><p>Flucelvax Tetra has no or negligible effect on your ability to drive and use machines.</p><p><strong>Flucelvax Tetra contains sodium chloride and potassium chloride</strong></p><p>This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’. This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium free’</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Flucelvax Tetra is given to you by your doctor or nurse as an injection into the muscle at the top of the upper arm (deltoid muscle).</p><p><em>Adults and children from 2 years of age:</em></p><p>One dose of 0.5 ml</p><p>If your child is younger than 9 years of age and has not been previously vaccinated against flu, a second dose should be given after at least 4 weeks.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported during clinical trials and during general use:</p><p><strong>Very serious side effects</strong></p><p>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:</p><ul><li>Difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction)</li></ul><p><strong>Serious side effects</strong></p><p>Tell your doctor immediately if you experience any of the following side effects – you may need medical attention:</p><ul><li>You feel weak, you have difficulty moving around or you experience numbness or tingling in your limbs. These can be symptoms of Guillain-Barré syndrome (GBS), an autoimmune disease caused by your body’s own immune system.</li><li>Extensive swelling of injected limb</li></ul><p><strong>Mild side effects</strong></p><p><em>Very common</em> (may affect more than 1 in 10 people):</p><ul><li>Injection site pain, bruising, reddening and hardening or swelling at the site of the injection</li><li>Headache</li><li>Muscle pain</li><li>Tiredness</li><li>Loss of appetite</li><li>Irritability (only reported in children from 2 to < 6 years)</li><li>Sleepiness (only reported in children 2 to < 6 years) Hardening or swelling at the site of the injection, headache, muscle pain, and tiredness were common in the elderly. Bruising at the site of the injection was common in adults, eldery and children 9 to < 18 years. Headache was common in the elderly. Loss of appetite was common in adults, eldery and children 9 to < 18 years.</li></ul><p><em>Common</em> (may affect up to 1 in 10 people):</p><ul><li>Nausea, vomiting, diarrhoea</li><li>Joint pain</li><li>Shivering</li><li>Change in eating habits (only reported in children from 2 to < 6 years)</li><li>Fever (> 38°C) Vomiting was uncommon in the elderly. Fever was uncommon in adults and the elderly.</li></ul><p><em>Not known</em> (frequency cannot be estimated from the available data):</p><ul><li>Numbness and tingling sensation (paraesthesia)</li><li>Generalised skin reactions including itching, bumps on the skin (pruritis, urticaria) or non-specific rash</li></ul><p><strong>Reporting of side effects</strong></p><p>If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.* By reporting side effects, you can help provide more information on the safety of this medicine.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Keep this vaccine out of the sight and reach of children. Store in a refrigerator (2 °C to 8 °C).</p><p>Do not freeze.</p><p>Keep the pre-filled syringe in the outer carton in order to protect from light.</p><p>Do not use this vaccine 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.</p><p>Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p><strong>What Flucelvax Tetra contains</strong></p><p>The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:</p><p>A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) 15 micrograms HA**</p><p>A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) 15 micrograms HA**</p><p>B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) 15 micrograms HA**</p><p>B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type) 15 micrograms HA**</p><p>per 0.5 ml dose</p><p>..............................................</p><p>* propagated in Madin Darby Canine Kidney (MDCK) cells (this is the special cell culture in which the influenza virus is grown);</p><p>** haemagglutinin</p><p>This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2022/2023 SEASON.</p><p>The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.</p><p><strong>What Flucelvax Tetra looks like and contents of the pack</strong></p><p>Flucelvax Tetra is a suspension for injection in a pre-filled syringe (ready to use syringe). Flucelvax Tetra is a clear to slightly opalescent suspension. A single syringe contains 0.5 ml of suspension for injection. Flucelvax Tetra is available in packs containing 1 pre-filled syringe with or without needle or 10 pre- filled syringes with or without needles. Not all pack sizes may be marketed.</p></div>
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<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>
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<substance>
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<entry>
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<Ingredient>
<id value="ingredient-for-f4e520e2974f4acb8abe26b607ea5a46"/>
<meta>
<profile
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<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>
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<reference
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<reference
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<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
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<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="BFA4LSE5QQ"/>
<display
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<code value="ACTIB"/>
<display value="active ingredient - basis of strength"/>
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<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"/>
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<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>
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<value value="B3EV5T8SUF"/>
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value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
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<for>
<reference
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<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
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<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="B3EV5T8SUF"/>
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<entry>
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value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-sodiumchloride"/>
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<Ingredient>
<id value="ingredient-for-flucelvax-sodiumchloride"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
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<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>
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<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>
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<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>
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<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="02F3473H9O"/>
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<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
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<for>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
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<for>
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
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<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
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<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="02F3473H9O"/>
<display value="MAGNESIUM CHLORIDE"/>
</coding>
</concept>
</code>
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</Ingredient>
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</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"/>
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<text>
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<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>
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<value value="94255I6E2T"/>
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<status value="active"/>
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value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
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<for>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
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<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
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<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
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<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>
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<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"/>
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<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>
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<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="4J9FJ0HL51"/>
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<status value="active"/>
<for>
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
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<for>
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
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</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>
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<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="059QF0KO0R"/>
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<status value="active"/>
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<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
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<for>
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
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<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>
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<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>
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<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>
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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>
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<value value="BFA4LSE5QQ"/>
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<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>
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<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"/>
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<unitOfPresentation>
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<display value="Human"/>
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<meta>
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<text>
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<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>
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<value value="EU/1/18/1326/001"/>
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<meta>
<profile
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<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>
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<identifier>
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<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="220000000034"/>
<display value="Marketing authorisation holder"/>
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<name value="Seqirus Netherlands B.V."/>
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<country value="Netherlands"/>
</address>
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<entry>
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value="http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-a854b6fee6a8536c78c604a4b9f6c395"/>
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<PackagedProductDefinition>
<id value="ppd-a854b6fee6a8536c78c604a4b9f6c395"/>
<meta>
<profile
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<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></blockquote></blockquote></div>
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<code value="100000155527"/>
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<status>
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<MedicinalProductDefinition>
<id value="mpb6ced64d25ea2c8da6c6099386f14db1"/>
<meta>
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<text>
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<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>
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<code value="100000000000"/>
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<meta>
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<text>
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<display value="suspension for injection in pre-filled syringe"/>
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<unitOfPresentation>
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<code value="200000002150"/>
<display value="Syringe"/>
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</ManufacturedItemDefinition>
</resource>
</entry>
</Bundle>
IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.gh#0.1.0 based on FHIR 5.0.0. Generated 2024-09-25
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.
