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
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "bundlepackageleaflet-en-a911acdcc16d3ea6bdce7272ad3df51a"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:identifier [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "None" ] ] ; # fhir:type [ fhir:v "document"] ; # fhir:timestamp [ fhir:v "2023-06-27T10:09:22Z"^^xsd:dateTime] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "Composition/composition-en-a911acdcc16d3ea6bdce7272ad3df51a"^^xsd:anyURI ] ; ( fhir:resource <Composition/composition-en-a911acdcc16d3ea6bdce7272ad3df51a> ) ] [ fhir:fullUrl [ fhir:v "MedicinalProductDefinition/mpa911acdcc16d3ea6bdce7272ad3df51a"^^xsd:anyURI ] ; ( fhir:resource <MedicinalProductDefinition/mpa911acdcc16d3ea6bdce7272ad3df51a> ) ] ) . # <Composition/composition-en-a911acdcc16d3ea6bdce7272ad3df51a> a fhir:Composition ; fhir:id [ fhir:v "composition-en-a911acdcc16d3ea6bdce7272ad3df51a"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><a name=\"Composition_composition-en-a911acdcc16d3ea6bdce7272ad3df51a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-a911acdcc16d3ea6bdce7272ad3df51a</b></p><a name=\"composition-en-a911acdcc16d3ea6bdce7272ad3df51a\"> </a><a name=\"hccomposition-en-a911acdcc16d3ea6bdce7272ad3df51a\"> </a><a name=\"composition-en-a911acdcc16d3ea6bdce7272ad3df51a-en-US\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Language: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/18/1298/001</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 - veyvondi</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>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU/1/18/1298/001" ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "Package Leaflet" ] ] ; # fhir:category ( [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs"^^xsd:anyURI ] ; fhir:code [ fhir:v "R" ] ; fhir:display [ fhir:v "Raw" ] ] ) ] ) ; # fhir:subject ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/mpa911acdcc16d3ea6bdce7272ad3df51a" ] ] ) ; # fhir:date [ fhir:v "2022-02-16T13:28:17Z"^^xsd:dateTime] ; # fhir:author ( [ fhir:reference [ fhir:v "Organization/mah-ema" ] ] ) ; # fhir:title [ fhir:v "TEST PURPOSES ONLY - veyvondi"] ; # fhir:attester ( [ fhir:mode [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/composition-attestation-mode"^^xsd:anyURI ] ; fhir:code [ fhir:v "official" ] ] ) ] ; fhir:time [ fhir:v "2022-02-16T13:28:17Z"^^xsd:dateTime ] ] ) ; # fhir:section ( [ fhir:title [ fhir:v "B. Package Leaflet" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "B. Package Leaflet" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>" ] ; fhir:emptyReason [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ; fhir:code [ fhir:v "unavailable" ] ] ) ] ; ( fhir:section [ fhir:title [ fhir:v "Package leaflet: Information for the user" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "Package leaflet: Information for the user" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "What is in this leaflet" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "What is in this leaflet" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What is in this leaflet</p><ol type=\"1\"><li>What VEYVONDI is and what it is used for</li><li>What you need to know before you use VEYVONDI</li><li>How to use VEYVONDI</li><li>Possible side effects</li><li>How to store VEYVONDI</li><li>Contents of the pack and other information</li></ol></div>" ] ] [ fhir:title [ fhir:v "1. What veyvondi is and what it is used for" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "1. What veyvondi is and what it is used for" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>VEYVONDI contains the active substance vonicog alfa, which is a recombinant human von Willebrand factor (rVWF). It behaves in the same way as natural human von Willebrand factor (VWF) in the body. VWF is the carrier molecule for coagulation factor VIII and is involved in blood clotting making platelets stick to wounds and so helps to form a blood clot. Lack of VWF increases the tendency to bleed.</p><p>VEYVONDI is used to prevent and treat bleeding episodes, including bleeding during surgery, in adult patients (aged 18 years and older) with von Willebrand disease. It is used when treatment with another medicine, desmopressin, is not effective or cannot be given.</p><p>Von Willebrand disease is an inherited bleeding disorder caused by the lack or an insufficient amount of von Willebrand factor. In patients with the disease the blood does not clot normally leading to a prolonged bleeding time. Administration of von Willebrand factor (VWF) allows for correction of von Willebrand factor deficiency.</p></div>" ] ] [ fhir:title [ fhir:v "2. What you need to know before you take veyvondi" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "2. What you need to know before you take veyvondi" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not use VEYVONDI</p><ul><li>if you are allergic to vonicog alfa or any of the other ingredients of this medicine (listed in section 6)</li><li>if you are allergic to mouse or hamster proteins</li></ul><p>If you are unsure about this, ask your doctor.</p><p>Warnings and precautions<br/>Talk to your doctor, pharmacist or nurse before using VEYVONDI.</p><p>There is a risk that you may experience a hypersensitivity reaction (a severe, sudden allergic reaction) to VEYVONDI. Your doctor should inform you about early signs of severe allergic reactions such as increased heart rate, rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, fast heartbeat, stuffy nose, red eyes,general feeling of being unwell, and dizziness. These could be early symptoms of a hypersensitivity reaction. If any of these symptoms occur, stop the infusion immediately and contact your doctor. Severe symptoms, including difficulty in breathing and dizziness, require prompt emergency treatment.</p><p>Patients developing inhibitors Inhibitors (antibodies) against the VWF may occur in some patients receiving the medicine.These inhibitors, especially at high levels, could cause the treatment to stop working properly. You will be monitored carefully for the possibility of having developed these inhibitors.</p><ul><li>If your bleeding is not controlled with VEYVONDI, tell your doctor immediately.</li></ul><p>If your plasma VWF or factor VIII fail to reach the expected levels with VEYVONDI based on the test results followed by your doctor, or if bleeding is not adequately controlled, it could be due to the presence of VWF or factor VIII antibodies. This will be checked by your doctor. You might need a higher dose of VEYVONDI, or a higher dose of factor VIII, or even a different medicine to control bleedings. Do not increase the total dose of VEYVONDI to control your bleeding without consulting your doctor.</p><p>If you have previously been treated with plasma-derived VWF concentrates you may have reduced response to VEYVONDI due to pre-existing antibodies. Your doctor may adjust the dose according to your laboratory results.</p><p>Thrombolism and embolism There is a risk of occurrence of thrombotic events if you have known clinical or laboratory risk factors. Therefore your doctor will monitor you for early signs of thrombosis.</p><p>FVIII products may contain varying amounts of VWF. Therefore, any FVIII product that would be administered in combination with VEYVONDI should be a pure FVIII product.</p><p>If you previously had problems with blood clots or vessel occlusion (thromboembolic complications), tell your doctor immediately.</p><p>Children and adolescents VEYVONDI is not approved for use in children or adolescents below 18 years.</p><p>Other medicines and VEYVONDI Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.</p><p>Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.</p><p>Driving and using machines VEYVONDI is not likely to affect your ability to drive and use machines.</p><p>VEYVONDI contains sodium This medicine contains 5.2 mg sodium (main component of cooking/table salt) in each 650 IU vial or 10.4 mg sodium in each 1300 IU vial.</p><p>This is equivalent to 2.2% of the recommended maximum daily dietary intake of sodium for an adult, assuming 70 kg body weight and 80 IU/kg body weight.</p><p>This should be taken into consideration if you are on a controlled sodium diet.</p></div>" ] ] [ fhir:title [ fhir:v "3. How to take veyvondi" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "3. How to take veyvondi" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Your treatment with VEYVONDI will be supervised by a doctor who is experienced in the care of patients with von Willebrand disease.</p><p>Your doctor will calculate your dose of VEYVONDI (in international units or IU). The dose depends on:</p><ul><li>body weight,</li><li>the site of the bleeding</li><li>intensity of the bleeding,</li><li>your clinical condition,</li><li>the required surgery</li><li>the VWF activity levels in your blood after surgery</li><li>the severity of your disease</li></ul><p>Your doctor may test your blood to make sure that you have adequate levels of von Willebrand factor. This is particularly important if you are having major surgery.</p><p>Treatment of bleeding episodes</p><p>Your doctor will calculate the dose that is most appropriate for you, how often you should receive VEYVONDI and for how long.</p><p>For minor bleeding (e.g. nose bleed, oral bleeding, menorrhagia), each initial dose is usually 40 to 50 IU/kg and for major bleeding (severe or refractory nose bleed, menorrhagia, gastrointestinal bleeding, Central nervous system trauma, haemarthrosis, or traumatic haemorrhage), each initial dose is 50 to 80 IU/kg. Subsequent doses (as clinically required) are 40 to 50 IU/kg every 8 to 24 hours for minor bleeds as long as deemed clinically necessary and for major bleeds 40 to 60 IU/kg for approximately 2-3 days.</p><p>If you feel that VEYVONDI is not working well enough, talk to your doctor. Your doctor will perform tests to make sure that you have adequate levels of von Willebrand factor. If you use VEYVONDI at home, your doctor will make sure that you are shown how to infuse it and how much to use.</p><p>Prevention of bleeding in case of elective surgery</p><p>For prevention of excessive bleeding your doctor will assess the FVIII:C levels within 3 hours before surgery. If your FVIII level is inadequate your doctor may give you a dose of 40-60 IU/kg VEYVONDI 12-24 hours (pre-operative dose) prior to initiating elective surgery in order to raise FVIII levels to the target level (0.4 IU/mL for minor and at least 0.8 IU/mL for major surgery). Within 1 hour prior to surgery, you will receive a dose of VEYVONDI based on the assessment 3 hours before surgery. The dose depends on VWF and FVIII levels of the patient, the type and severity of the expected bleeding.</p><p>Prophylaxis treatment</p><p>The usual starting dose for long term prophylaxis against bleeding episodes is 40 to 60 IU/kg twice weekly. The dose can be adjusted to a maximum of 80 IU/kg one to three times per week, depending on your condition and how well VEYVONDI is working for you. Your doctor will calculate the dose that is most appropriate for you, how often you should receive VEYVONDI and for how long.</p><p>How VEYVONDI is given VEYVONDI is usually infused into a vein (intravenously) by your doctor or nurse. Detailed instructions for reconstitution and admnistration are given at the end of this package leaflet.</p><p>Use in children and adolescents VEYVONDI is not approved for use in children and adolescents below 18 years.<br/>If you use more VEYVONDI than you should Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. If you infuse more VEYVONDI than recommended, tell your doctor as soon as possible. There may be a risk of developing blood clots (thrombosis) in case of an accidental high dose.</p><p>If you forget to use VEYVONDI</p><ul><li>Do not infuse a double dose to make up for a forgotten dose.</li><li>Proceed with the next infusion as scheduled and continue as advised by your doctor.</li></ul><p>If you stop using VEYVONDI Do not stop using VEYVONDI without consulting your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.</p></div>" ] ] [ fhir:title [ fhir:v "4. Possible side effects" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "4. Possible side effects" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Like all medicines, this medicine may cause side effects, although not everybody gets them.</p><p>You can have a serious allergic reaction to VEYVONDI.</p><p>You must stop the infusion and contact your doctor immediately if you have any of the following early symptoms of severe allergic reactions:</p><ul><li>rash or hives, itching all over the body,</li><li>tightness of the throat, chest pain or chest tightness,</li><li>difficulty breathing, light headedness, fast heartbeat,</li><li>dizziness, nausea or fainting.</li></ul><p>The following side effects have been reported with VEYVONDI:</p><p>Very common (may affect more than 1 in 10 people)</p><ul><li>headache</li></ul><p>Common (may affect up to 1 in 10 people)</p><ul><li>nausea</li><li>vomiting</li><li>tingling or burning at infusion site</li><li>chest discomfort</li><li>dizziness</li><li>vertigo</li><li>blood clots</li><li>hot flushes</li><li>itching</li><li>high blood pressure</li><li>muscle twitching</li><li>unusual taste</li><li>increased heart rate</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>" ] ] [ fhir:title [ fhir:v "5. How to store veyvondi" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "5. How to store veyvondi" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir: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 the vial label after EXP. The expiry date refers to the last day of that month.</li><li>Store below 30 C.</li><li>Do not freeze.</li><li>Store in the original package in order to protect from light.</li><li>Do not refrigerate the solution after preparation.</li><li>Use the reconstituted product within 3 hours to avoid the risk of microbial contamination, because the product does not contain preservatives.</li><li>This medicine is for single use only. Discard any unused solution appropriately.</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>" ] ] [ fhir:title [ fhir:v "6. Contents of the pack and other information" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "6. Contents of the pack and other information" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What VEYVONDI contains<br/>The active substance is vonicog alfa (recombinant human von Willebrand factor).</p><p>VEYVONDI 650 IU powder and solvent for solution for injection</p><p>Each vial of powder contains nominally 650 International Units (IU) vonicog alfa. After reconstitution with the 5 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa.</p><p>VEYVONDI 1300 IU powder and solvent for solution for injection</p><p>Each vial of powder contains nominally 1300 International Units (IU) vonicog alfa. After reconstitution with the 10 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa.</p><p>The other ingredients are:</p><ul><li>Sodium citrate, glycine, trehalose dihydrate, mannitol, polysorbate 80 and water for injections.</li><li>See section 2 VEYVONDI contains sodium .</li></ul><p>What VEYVONDI looks like and contents of the pack VEYVONDI is a white to off-white powder. After reconstitution, when drawn into the syringe, the solution is clear, colourless in appearance and free from flakes or other foreign particles.</p><p>Each pack of VEYVONDI 650 IU contains:</p><ul><li>powder in a glass vial with a rubber stopper</li><li>5 mL of solvent in a glass vial with a rubber stopper</li><li>one reconstitution device (Mix2Vial)</li></ul><p>Each pack of VEYVONDI 1300 IU contains:</p><ul><li>powder in a glass vial with a rubber stopper</li><li>10 mL of solvent in a glass vial with a rubber stopper</li><li>one reconstitution device (Mix2Vial)</li></ul><p>Marketing Authorisation Holder<br/>Baxalta Innovations GmbH Industriestrasse 1221 Vienna Austria</p><p>Manufacturer Takeda Manufacturing Austria AG Industriestrasse 1221 Vienna Austria</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien Takeda Belgium NV T l/Tel: +32 2 464 06 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Lietuva Takeda, UAB Tel: +370 521 09 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>.: +359 2 958 27 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Luxembourg/Luxemburg Takeda Belgium NV T l/Tel: +32 2 464 06 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>esk republika Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Magyarorsz g Takeda Pharma Kft. Tel.: +36 1 270 <a href=\"mailto:7medinfoEMEA@takeda.com\">7medinfoEMEA@takeda.com</a></p><p>Danmark Takeda Pharma A/S Tlf: +45 46 77 10 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Malta akeda HELLAS S.A. Tel: +30 210 <a href=\"mailto:6387medinfoEMEA@takeda.com\">6387medinfoEMEA@takeda.com</a></p><p>Deutschland Takeda GmbH Tel: +49 (0)800 825 <a href=\"mailto:3medinfoEMEA@takeda.com\">3medinfoEMEA@takeda.com</a></p><p>Nederland Takeda Nederland B.V. Tel: +31 20 203 <a href=\"mailto:5medinfoEMEA@takeda.com\">5medinfoEMEA@takeda.com</a></p><p>Eesti Takeda Pharma AS Tel: +372 6177 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Norge Takeda AS Tlf: +47 800 800 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>akeda . . T : +30 210 <a href=\"mailto:6387medinfoEMEA@takeda.com\">6387medinfoEMEA@takeda.com</a></p><p>sterreich Takeda Pharma Ges.m.b.H.<br/>Tel: +43 (0) 800-20 80 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Espa a Takeda Farmac utica Espa a, S.A. Tel: +34 917 90 42 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Polska Takeda Pharma Sp. z o.o. Tel.: <a href=\"mailto:+48223062medinfoEMEA@takeda.com\">+48223062medinfoEMEA@takeda.com</a></p><p>France Takeda France SAS Portugal Takeda Farmac uticos Portugal, Lda. T l: + 33 1 40 67 33 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Tel: + 351 21 120 <a href=\"mailto:1medinfoEMEA@takeda.com\">1medinfoEMEA@takeda.com</a></p><p>Hrvatska Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Rom nia Takeda Pharmaceuticals SRL Tel: +40 21 335 03 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Ireland Takeda Products Ireland Ltd Tel: 1800 937 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Slovenija Takeda Pharmaceuticals farmacevtska dru ba d.o.o. Tel: + 386 (0) 59 082 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>sland Vistor hf. S mi: +354 535 <a href=\"mailto:7medinfoEMEA@takeda.com\">7medinfoEMEA@takeda.com</a></p><p>Slovensk republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Italia Takeda Italia S.p.A. Tel: +39 06 <a href=\"mailto:502medinfoEMEA@takeda.com\">502medinfoEMEA@takeda.com</a></p><p>Suomi/Finland Takeda Oy Puh/Tel: 0800 774 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>akeda . . : +30 210 <a href=\"mailto:6387medinfoEMEA@takeda.com\">6387medinfoEMEA@takeda.com</a></p><p>Sverige Takeda Pharma AB Tel: 020 795 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Latvija Takeda Latvia SIA Tel: +371 <a href=\"mailto:67840medinfoEMEA@takeda.com\">67840medinfoEMEA@takeda.com</a> United Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 (0) 2830 640 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>This leaflet was last revised in .</p><p>Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>" ] ] ) ] ) . # <MedicinalProductDefinition/mpa911acdcc16d3ea6bdce7272ad3df51a> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "mpa911acdcc16d3ea6bdce7272ad3df51a"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mpa911acdcc16d3ea6bdce7272ad3df51a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mpa911acdcc16d3ea6bdce7272ad3df51a</b></p><a name=\"mpa911acdcc16d3ea6bdce7272ad3df51a\"> </a><a name=\"hcmpa911acdcc16d3ea6bdce7272ad3df51a\"> </a><a name=\"mpa911acdcc16d3ea6bdce7272ad3df51a-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/18/1298/001</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>: VEYVONDI 650 IU powder and solvent for solution for injection</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>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU/1/18/1298/001" ] ] ) ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "MedicinalProduct" ] ; fhir:display [ fhir:v "Medicinal Product" ] ] ) ] ; # fhir:domain [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-domain"^^xsd:anyURI ] ; fhir:code [ fhir:v "Human" ] ; fhir:display [ fhir:v "Human use" ] ] ) ] ; # fhir:status [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ; fhir:code [ fhir:v "active" ] ; fhir:display [ fhir:v "active" ] ] ) ] ; # fhir:legalStatusOfSupply [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000072084" ] ; fhir:display [ fhir:v "Medicinal product subject to medical prescription" ] ] ) ] ; # fhir:name ( [ fhir:productName [ fhir:v "VEYVONDI 650 IU powder and solvent for solution for injection" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000001" ] ; fhir:display [ fhir:v "Full name" ] ] ) ] ; ( fhir:part [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000002" ] ; fhir:display [ fhir:v "Invented name part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000003" ] ; fhir:display [ fhir:v "Scientific name part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000004" ] ; fhir:display [ fhir:v "Strength part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000005" ] ; fhir:display [ fhir:v "Pharmaceutical dose form part" ] ] ) ] ] ) ; ( fhir:usage [ fhir:country [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "EU" ] ; fhir:display [ fhir:v "EU" ] ] ) ] ; fhir:jurisdiction [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "EU" ] ; fhir:display [ fhir:v "EU" ] ] ) ] ; fhir:language [ ( fhir:coding [ fhir:system [ fhir:v "urn:ietf:bcp:47"^^xsd:anyURI ] ; fhir:code [ fhir:v "en" ] ; fhir:display [ fhir:v "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.
