Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/joofio/test-epi-composition/ and changes regularly. See the Directory of published versions
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><a name=\"Composition_composition-en-7a98a4feed53c51bdbb3ffa9d578b887\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-7a98a4feed53c51bdbb3ffa9d578b887</b></p><a name=\"composition-en-7a98a4feed53c51bdbb3ffa9d578b887\"> </a><a name=\"hccomposition-en-7a98a4feed53c51bdbb3ffa9d578b887\"> </a><a name=\"composition-en-7a98a4feed53c51bdbb3ffa9d578b887-en-US\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Language: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/15/1001/001</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi/ 100000155538}\">Package Leaflet</span></p><p><b>category</b>: <span title=\"Codes:{http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs R}\">Raw</span></p><p><b>date</b>: 2022-02-16 13:28:17+0000</p><p><b>author</b>: <a href=\"Organization-mah-ema.html\">Organization ACME industry</a></p><p><b>title</b>: TEST PURPOSES ONLY - akynzeo</p><h3>Attesters</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/composition-attestation-mode official}\">Official</span></td><td>2022-02-16 13:28:17+0000</td></tr></table></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What is in this leaflet</p><ol type=\"1\"><li>What Akynzeo is and what it is used for</li><li>What you need to know before you take Akynzeo</li><li>How to take Akynzeo</li><li>Possible side effects</li><li>How to store Akynzeo</li><li>Contents of the pack and other information</li></ol></div>"
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"title" : "1. What akynzeo is and what it is used for",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Akynzeo is<br/>Akynzeo contains two medicines ( active substances ) called:</p><ul><li>netupitant</li><li>palonosetron.</li></ul><p>What Akynzeo is used for Akynzeo is used to help prevent adults with cancer feeling sick (nausea) or being sick (vomiting) while having cancer treatment called chemotherapy .</p><p>How Akynzeo works Chemotherapy medicines can cause the body to release substances called serotonin and substance P. This stimulates the vomiting centre in the brain, making you feel or be sick. The medicines in Akynzeo attach to the receptors in the nervous system through which serotonin and substance P work: netupitant (an NK1 receptor antagonist) blocks the receptors for substance P, and palonosetron (a 5- HT3 receptor antagonist) blocks certain receptors for serotonin. By blocking the actions of substance P and serotonin in this way, the medicines help prevent the stimulation of the vomiting centre and the resulting sickness.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not take Akynzeo if:</p><ul><li>you are allergic to netupitant or palonosetron, or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor, pharmacist or nurse before taking this medicine.</li><li>you are pregnant.</li></ul><p>Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Akynzeo if:</p><ul><li>you have liver problems</li><li>you have a blockage in your gut, or you have had constipation in the past</li><li>you or one of your close relatives has ever had a heart problem called QT interval prolongation</li><li>you have any other heart problems</li><li>you have been told you have an imbalance of minerals in your blood such as potassium and magnesium that has not been corrected.</li></ul><p>If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Akynzeo.</p><p>Children and adolescents Akynzeo should not be taken by children and adolescents under 18 years.</p><p>Other medicines and Akynzeo Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.</p><p>In particular tell your doctor, pharmacist or nurse if you are taking any of the following medicines:</p><ul><li>medicines for depression or anxiety called SSRIs (selective serotonin re-uptake inhibitors) - such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram or escitalopram</li><li>medicines for depression or anxiety called SNRIs (serotonin noradrenaline re-uptake inhibitors)</li></ul><ul><li>such as venlafaxine or duloxetine.</li></ul><p>Also tell your doctor, pharmacist or nurse if you are taking any of the following medicines as your doctor may need to change the dose of these other medicines:</p><ul><li>medicines that might cause abnormal heartbeat such as amiodarone, nicardipine, quinidine, moxifloxacin, haloperidol, chlorpromazine, quetiapine, thioridazine or domperidone</li><li>medicines with a narrow therapeutic range that are primarily metabolised by CYP3A4, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, or quinidine</li><li>some chemotherapy medicines - such as docetaxel or etoposide</li><li>erythromycin - to treat bacterial infections</li><li>midazolam - a sedative used to treat anxiety</li><li>dexamethasone - can be used to treat feeling and being sick</li><li>ketoconazole - to treat Cushing's syndrome</li><li>rifampicin - to treat tuberculosis (TB) and other infections.</li></ul><p>If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Akynzeo.</p><p>Pregnancy and breast-feeding<br/>If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.</p><p>Do not take Akynzeo if you are pregnant or if you are a woman of childbearing potential not using contraception.</p><p>Do not breast-feed if you are taking Akynzeo. This is because it is not known whether the medicine passes into breast milk.</p><p>Driving and using machines You may feel dizzy or tired after taking Akynzeo. If this happens, do not drive or use any tools or machines.</p><p>Akynzeo contains sucrose, sorbitol (E420), sodium and may contain traces of soya<br/>If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.</p><p>This medicine contains 7 mg of sorbitol (E420) in each hard capsule.</p><p>This medicine contains less than 1 mmol sodium per (23 mg) per hard capsule, that is to say essentially sodium-free .</p><p>It may contain traces of lecithin - which comes from soya. If you are allergic to peanut or soya, do not use this medicinal product.</p></div>"
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"title" : "3. How to take akynzeo",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.</p><p>How much to take</p><ul><li>The recommended dose is one capsule (each capsule contains 300 mg of netupitant and 0.5 mg of palonosetron).</li><li>Take the capsule about 1 hour before you start your chemotherapy cycle.</li><li>You can take Akynzeo with or without food.</li></ul><p>Akynzeo is taken before the chemotherapy to prevent sickness and feelings of sickness from developing. Do not take Akynzeo in the days after you have chemotherapy - unless you are about to have another chemotherapy cycle.</p><p>If you take more Akynzeo than you should The usual dose is 1 capsule. If you think you may have taken more than you should, tell your doctor straight away. The symptoms of overdose may include headache, dizziness, constipation, anxiety, palpitations, euphoric mood and pain in the legs.</p><p>If you forget to take Akynzeo If you think you have forgotten to take your dose, tell your doctor straight away.</p><p>If you stop taking Akynzeo<br/>Akynzeo is taken to help prevent you feeling and being sick when you are having chemotherapy. If you do not want to take Akynzeo, discuss this with your doctor. If you decide not to take Akynzeo (or another similar medicine), your chemotherapy is likely to make you feel sick and be sick.</p><p>If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Like all medicines, this medicine can cause side effects, although not everybody gets them.</p><p>Serious side effects<br/>Stop taking Akynzeo and tell your doctor straight away if you notice the following serious side effect - you may need urgent medical treatment:</p><p>Very rare: may affect up to 1 in 10,000 people</p><ul><li>severe allergic reaction signs include hives, skin rash, itching, difficulty breathing or swallowing, swollen mouth, face, lips, tongue or throat and sometimes a drop in blood pressure.</li></ul><p>Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:</p><p>Common: (may affect up to 1 in 10 people)</p><ul><li>headache</li><li>constipation</li><li>feeling tired.</li></ul><p>Uncommon: (may affect up to 1 in 100 people)</p><ul><li>hair loss</li><li>lack of energy (feeling weak)</li><li>decreased appetite</li><li>high blood pressure</li><li>raised, itchy rash on the skin (hives)</li><li>problems with the muscles in your heart (cardiomyopathy)</li><li>spinning sensation (vertigo), feeling dizzy or trouble sleeping (insomnia)</li><li>stomach problems including stomach discomfort, feeling bloated, nausea, pain, indigestion, hiccups, wind or diarrhoea</li><li>high levels of certain enzymes, including blood alkaline phosphatase and liver transaminases (shown in blood tests)</li><li>high levels of creatinine - which measures kidney function (shown in blood tests)</li><li>ECG (electrocardiogram) problems (called QT and PR interval prolongation , conduction disorder , tachycardia and atrioventricular block first degree )</li><li>low levels of neutrophils - a kind of white blood cell which fight infections (shown in blood tests)</li><li>high level of white blood cells (shown in blood tests).</li></ul><p>Rare: (may affect up to 1 in 1 000 people)</p><ul><li>back pain, joint pain</li><li>feeling hot, reddening of the face or other areas of the skin (feeling flushed)</li><li>itchy skin rash</li><li>feeling drowsy</li><li>sleep problems</li><li>ring in the ear</li><li>vomiting</li><li>low blood pressure</li><li>chest pain (not related to the heart)</li><li>numbness, blurred vision</li><li>sudden nervous breakdown, change in mood</li><li>infection and inflammation in the bladder (cystitis)</li><li>haemorrhoids</li><li>conjunctivitis (a type of eye inflammation)</li><li>low level of potassium (shown in blood tests)</li><li>modifications (or disturbances) in heart rhythm</li><li>heart valve disorder (mitral valve incompetence)</li><li>coating of the tongue, difficulty swallowing, dry mouth, belching, abnormal taste after medicine intake</li><li>decreased blood flow to the heart muscle (myocardial ischemia)</li><li>high levels of creatine phosphokinase/ creatine phosphokinase MB - which indicates sudden decreased blood flow to the heart muscle (shown in blood tests)</li><li>high levels of troponin - which indicates heart muscle dysfunction (shown in blood tests)</li><li>high levels of the pigment bilirubin - which indicates liver dysfunction (shown in blood tests)</li><li>high levels of myoglobin which indicates muscle injury (shown in blood tests)</li><li>high levels of blood urea which indicates kidney dysfunction (shown in blood tests)</li><li>high level of lymphocytes type of white blood cell which help the body fight disease (shown in blood tests)</li><li>low level of white blood cells (shown in blood tests)</li><li>ECG (electrocardiogram) problems (called ST segment depression , ST-T segment abnormal<br/>bundle branch block right/left , and atrioventricular block second degree )</li></ul><p>Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V By reporting side effects, you can help provide more information on the safety of this medicine.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><ul><li>Keep this medicine out of the sight and reach of children.</li><li>Do not use this medicine after the expiry date which is stated on the carton and blister after EXP . The expiry date refers to the last day of that month.</li><li>This medicine does not require any special storage conditions.</li><li>Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.</li></ul></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Akynzeo contains</p><ul><li>The active substances are palonosetron and netupitant. Each hard capsule contains three tablets (300 mg of netupitant), and one soft capsule (palonosetron hydrochloride equivalent to 0.5 milligrams of palonosetron).</li><li>The other ingredients are microcrystalline cellulose (E460), sucrose lauric acid esters, povidone K-30, croscarmellose sodium, colloidal hydrated silica, sodium stearyl fumarate, magnesium stearate, glycerol monocaprylocaproate (type I), glycerol, polyglyceryl oleate, purified water, butylhydroxyanisole (E320), gelatin, sorbitol (E420), 1,4 sorbitan, titanium dioxide (E171), shellac glaze (partially esterified), yellow, red and black iron oxide (E172), propylene glycol (E1520).</li></ul><p>This medicine contains sucrose, sorbitol (E420), sodium and may contain soya - see section 2 for more information.</p><p>What Akynzeo looks like and contents of the pack The hard capsules are opaque with a white body and a caramel cap with HE1 printed on the body. Pack size containing 1 capsule in an aluminium blister or 4 x 1 hard capsules in aluminium perforated unit dose blisters. Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder and Manufacturer: Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart Dublin Ireland</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien Immedica Pharma AB T l/Tel: + 46(0)8 533 39 Lietuva Farma Mondo Tel: + 370 689 36<br/>Angelini Pharma Bulgaria EOOD Te .: +359 2 975 13 Luxembourg/Luxemburg Immedica Pharma AB T l/Tel: + 46(0)8 533 39 esk republika Angelini Pharma esk republika s.r.o. Tel: (+420) 546 123 Magyarorsz g Angelini Pharma Magyarorsz g Kft Tel.: + 36 1 336 1Danmark Swedish Orphan Biovitrum A/S Tlf: + 45 32 96 68 Malta Helsinn Birex Pharmaceuticals Ltd.<br/>Tel.: + 353 1 822 5Deutschland Esteve Pharmaceuticals GmbH Tel: + 49 30 338427-0</p><p>Nederland Immedica Pharma AB Tel: + 46(0)8 533 39 Eesti Farma Mondo Tel: + 370 698 36Norge Swedish Orphan Biovitrum AS Tlf: +47 66 82 34<br/>Galenica A.E. : +30 210 52 81 sterreich Angelini Pharma sterreich GmbH Tel: +43-5-9-606-0</p><p>Espa a Immedica Pharma AB Tel: +34(0)9 373 70 Polska Angelini Pharma Polska Sp. z o.o. Tel: +48 22 70 28 France Immedica Pharma France SARL T l: + 33(0)148 014 Portugal Immedica Pharma AB Tel: + 46(0)8 533 39 Hrvatska Bausch Health Poland sp. z.o.o. podru nica Zagreb<br/>Tel: +385 1 670 0Rom nia Angelini Pharmaceuticals Romania Srl Tel: +40 21 331 67 Ireland Chugai Pharma France Tel: +33 1 79 36 36 Slovenija PharmaSwiss Tel: +386 1 2364 sland Swedish Orphan Biovitrum A/S Tlf: + 45 32 96 68 Slovensk republika Angelini Pharma Slovensk republika s.r.o. Tel: +421 2 5920 7Italia Italfarmaco Tel: + 39 02 64Suomi/Finland Oy Swedish Orphan Biovitrum Ab Puh./Tel: +358 201 558<br/>Galenica A.E. : +30 210 52 81 Sverige Swedish Orphan Biovitrum AB (publ) Tel: +46 8 697 20 Latvija Farma Mondo Tel: + 370 698 36United Kingdom (Northern Ireland) Chugai Pharma France Tel: +33 1 79 36 36 This leaflet was last revised in</p><p>Detailed information on this medicine is available on the European Medicines Agency website <a href=\"http://www.ema.europa.eu\">http://www.ema.europa.eu</a>.</p><p>Package Leaflet: Information for the patient</p><p>Akynzeo 235 mg/0.25 mg powder for concentrate for solution for infusion fosnetupitant/palonosetron</p><p>Read all of this leaflet carefully before you are given this medicine because it contains important information for you.</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" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mp7a98a4feed53c51bdbb3ffa9d578b887\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mp7a98a4feed53c51bdbb3ffa9d578b887</b></p><a name=\"mp7a98a4feed53c51bdbb3ffa9d578b887\"> </a><a name=\"hcmp7a98a4feed53c51bdbb3ffa9d578b887\"> </a><a name=\"mp7a98a4feed53c51bdbb3ffa9d578b887-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/15/1001/001</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}\">Medicinal Product</span></p><p><b>domain</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-domain Human}\">Human use</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">active</span></p><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072084}\">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Akynzeo 300 mg/0.5 mg hard capsules</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}\">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}\">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}\">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 EU}\">EU</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 EU}\">EU</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 en}\">en</span></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "http://ema.europa.eu/identifier",
"value" : "EU/1/15/1001/001"
}
],
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-type",
"code" : "MedicinalProduct",
"display" : "Medicinal Product"
}
]
},
"domain" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-domain",
"code" : "Human",
"display" : "Human use"
}
]
},
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "active"
}
]
},
"legalStatusOfSupply" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000072084",
"display" : "Medicinal product subject to medical prescription"
}
]
},
"name" : [
{
"productName" : "Akynzeo 300 mg/0.5 mg hard capsules",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000001",
"display" : "Full name"
}
]
},
"part" : [
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000002",
"display" : "Invented name part"
}
]
}
},
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000003",
"display" : "Scientific name part"
}
]
}
},
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000004",
"display" : "Strength part"
}
]
}
},
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000005",
"display" : "Pharmaceutical dose form part"
}
]
}
}
],
"usage" : [
{
"country" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "EU",
"display" : "EU"
}
]
},
"jurisdiction" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "EU",
"display" : "EU"
}
]
},
"language" : {
"coding" : [
{
"system" : "urn:ietf:bcp:47",
"code" : "en",
"display" : "en"
}
]
}
}
]
}
]
}
}
]
}
IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.ghepi#0.1.0 based on FHIR 5.0.0. Generated 2024-10-14
Links: Table of Contents |
QA Report
The Gravitate Health project has received funding from the IMI 2 Joint Undertaking under grant agreement No 945334.
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.
