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-639cce8c495cbcbb29789688f0c06663"] ; # 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-639cce8c495cbcbb29789688f0c06663"^^xsd:anyURI ] ; ( fhir:resource <Composition/composition-en-639cce8c495cbcbb29789688f0c06663> ) ] [ fhir:fullUrl [ fhir:v "MedicinalProductDefinition/mp639cce8c495cbcbb29789688f0c06663"^^xsd:anyURI ] ; ( fhir:resource <MedicinalProductDefinition/mp639cce8c495cbcbb29789688f0c06663> ) ] ) . # <Composition/composition-en-639cce8c495cbcbb29789688f0c06663> a fhir:Composition ; fhir:id [ fhir:v "composition-en-639cce8c495cbcbb29789688f0c06663"] ; # 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-639cce8c495cbcbb29789688f0c06663\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-639cce8c495cbcbb29789688f0c06663</b></p><a name=\"composition-en-639cce8c495cbcbb29789688f0c06663\"> </a><a name=\"hccomposition-en-639cce8c495cbcbb29789688f0c06663\"> </a><a name=\"composition-en-639cce8c495cbcbb29789688f0c06663-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/1/22/1714/001</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 - pombiliti</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/1/22/1714/001" ] ] ) ; # 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/mp639cce8c495cbcbb29789688f0c06663" ] ] ) ; # 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 - pombiliti"] ; # 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 Pombiliti is and what it is used for</li><li>What you need to know before you are given Pombiliti</li><li>How Pombiliti is given</li><li>Possible side effects</li><li>How to store Pombiliti</li><li>Contents of the pack and other information</li></ol></div>" ] ] [ fhir:title [ fhir:v "1. What pombiliti 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 pombiliti 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>What Pombiliti is Pombiliti is a type of enzyme-replacement therapy (ERT) that is used in the treatment of late-onset Pompe disease in adults. It contains the active substance cipaglucosidase alfa .</p><p>What it is used for Pombiliti is always used with another medicine called miglustat 65 mg hard capsules. It is very important that you also read the package leaflet of miglustat 65 mg hard capsules.</p><p>If you have any questions about your medicines, please ask your doctor or pharmacist.</p><p>How Pombiliti works People with Pompe disease have low levels of the enzyme acid alpha-glucosidase (GAA). This enzyme helps control levels of glycogen (a type of carbohydrate) in the body.</p><p>In Pompe disease, high levels of glycogen build up in the muscles of the body. This keeps muscles, such as the muscles that help you walk, the muscles under the lungs that help you breathe, and the heart muscle, from working properly.</p><p>Pombiliti enters the muscle cells that are affected by Pompe disease. When in the cells, the medicine works like GAA to help break down glycogen and control its levels.</p></div>" ] ] [ fhir:title [ fhir:v "2. What you need to know before you take pombiliti" ] ; 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 pombiliti" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>You must not be given Pombiliti</p><ul><li>If you have ever had life-threatening hypersensitivity reactions to:</li></ul><p>cipaglucosidase alfa</p><p>miglustat</p><p>any of the other ingredients of this medicine (listed in section 6).</p><ul><li>If a previous infusion had to be stopped and could not be restarted due to life threatening hypersensitivity reactions.</li></ul><p>Warnings and precautions Talk to your doctor, pharmacist, or nurse before using Pombiliti.</p><p>Speak to your doctor or nurse immediately if these apply to you, if you think it might apply to you or if you have ever had any such reactions with another enzyme replacement therapy (ERT):</p><ul><li>allergic reactions, including anaphylaxis (a severe allergic reaction) see section 4 under Possible side effects , below for symptoms of life-threatening reactions.</li><li>infusion-associated reaction while you are receiving the medicine or in the few hours afterwards - see section 4 under Possible side effects , below for symptoms of life-threatening reactions.</li></ul><p>Inform your doctor if you have a history of heart or lung disease. These conditions may worsen during or immediately after your infusion with Pombiliti. Tell a doctor or nurse immediately if you are experiencing shortness of breath, cough, rapid or irregular heartbeat or any other effects from these conditions.</p><p>Also tell your doctor if you have swelling in your legs or widespread swelling of your body, severe skin rash or frothy urine when passing water. Your doctor will decide if your Pombiliti infusion should stop, and the doctor will give you appropriate medical treatment. Your doctor will also decide if you can continue receiving Pombiliti.</p><p>Pre-treatment medications Your doctor may give you other medicines before you have Pombiliti. These medicines include:</p><ul><li>antihistamines and corticosteroids to prevent or help reduce infusion-related reactions.</li><li>antipyretics to reduce fever.</li></ul><p>Children and adolescents This medicine should not be given to patients under the age of 18 years old. This is because the effects of Pombiliti in conjunction with miglustat in this age group are not known.</p><p>Other medicines and Pombiliti Tell a doctor or nurse if you are using, have recently used, or will be using any other medicines. This includes medicines obtained without a prescription, including herbal 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, do not take this medicine but talk to your doctor or pharmacist immediately for advice before using this medicine.</p><p>There is no experience with the use of Pombiliti in combination with miglustat during pregnancy.</p><ul><li>You should not receive Pombiliti and / or take miglustat 65 mg hard capsules if you are pregnant. Be sure to tell your doctor immediately if you get pregnant, think that you may be pregnant, or if you are planning to become pregnant. There may be risks to the unborn baby.</li><li>Pombiliti in combination with miglustat should not be given to women who are breast-feeding. A decision will need to be made whether to stop treatment or to stop breast-feeding.</li></ul><p>Contraception and fertility Female patients of childbearing potential must use reliable birth control methods during and for 4 weeks after stopping both medicines.</p><p>Driving and using machines You may feel dizzy, sleepy, or have low blood pressure (hypotensive) after having Pombiliti or pre-treatment medicines. If this happens, do not drive or use any tools or machines. Pombiliti contains sodium This medicinal product contains 10.5 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 0.52% of the recommended maximum daily dietary intake of sodium for an adult.</p></div>" ] ] [ fhir:title [ fhir:v "3. How to take pombiliti" ] ; 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 pombiliti" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Pombiliti is given to you by a doctor or nurse. It is given through a drip into a vein. This is called an intravenous infusion. Talk to your doctor if you would like to be treated at home. Your doctor will decide upon evaluation if it is safe for you to have home infusion of Pombiliti. If you get any side effects during an infusion of Pombiliti, your home infusion staff member may stop the infusion and start appropriate medical treatment.</p><p>Pombiliti should be used in conjunction with miglustat. You can only use miglustat 65 mg capsules with cipaglucosidase alfa. Do NOT use miglustat 100 mg capsules (different product). Follow your doctor s instructions and read the package leaflet of miglustat 65 mg hard capsules for their recommended dose.</p><p>How much Pombiliti is given The amount of medicine that you will be given is based on your weight. The recommended dose is 20 mg for each kg of body weight. When and for how long Pombiliti is given</p><ul><li>You will be treated with Pombiliti once every other week. Miglustat 65 mg capsules are taken on the same day as Pombiliti. Refer to the package leaflet of miglustat 65 mg hard capsules for information on how to take miglustat.</li><li>The cipaglucosidase alfa infusion should start 1 hour after taking miglustat 65 mg hard capsules.</li></ul><p>In the event of a delay, the start of infusion should not exceed 3 hours from taking miglustat. The infusion of cipaglucosidase alfa lasts approximately 4 hours.</p><p>Figure 1. Dose timeline</p><ul><li>The cipaglucosidase alfa infusion should start 1 hour after taking miglustat capsules. In the event of infusion delay, the start of infusion should not exceed 3 hours from taking miglustat.</li></ul><p>Switching from another enzyme replacement therapy (ERT) If you are currently being treated with another ERT:</p><ul><li>Your doctor will tell you when to stop the other ERT before starting Pombiliti.</li><li>Tell your doctor when you completed your last dose.</li></ul><p>If you are given more Pombiliti than you should If you have difficulty breathing, feel swollen or bloated, or your heart is racing, you may have been given too much Pombiliti; tell your doctor straight away. Excessive rate of infusion of Pombiliti could result in symptoms related to too much fluid in the body, such as shortness of breath, rapid heart rate, or widespread swelling of the body.</p><p>If you miss your dose of Pombiliti If you have missed an infusion, please contact your doctor or nurse as soon as possible to reschedule Pombiliti in combination with miglustat 24 hours after miglustat was last taken.</p><p>If you stop receiving Pombiliti Speak to your doctor if you wish to stop Pombiliti treatment. The symptoms of your disease may worsen if you stop treatment.</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 can cause side effects, although not everybody gets them.</p><p>Pombiliti is used with miglustat, and side effects can occur with either of these medicines. Side effects were mainly seen while patients were being infused with Pombiliti (infusion-related effects) or shortly after. You must tell your doctor immediately if you get an infusion-associated reaction or an allergic reaction. Some of these reactions may become serious and life-threatening. Your doctor may give you medicines before your infusion to prevent these reactions.</p><p>Infusion-associated reactions Most infusion-associated reactions are mild or moderate. Symptoms of infusion-associated reaction may include difficulty breathing, bloating, fever, chills, dizziness, skin redness, itchy skin, and rash.</p><p>Allergic reactions Allergic reactions may include symptoms such as rash anywhere on the body, puffy eyes, prolonged difficulty breathing, cough, swelling of the lip, tongue, or throat, itchy skin, and hives.</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>Cough</li><li>Sudden reddening of the face, neck, or upper chest</li><li>Pain in chest</li><li>Rash, itching</li><li>Rise in blood pressure</li><li>Sweating</li><li>Bloating</li><li>Passing gas or wind</li><li>Loose, runny stools</li><li>Vomiting</li><li>Nausea</li><li>Fever or chills</li><li>Hives</li><li>Swelling or pain in the body area where needle was inserted</li><li>Muscle cramps, muscle pain, muscle weakness</li><li>Involuntary shaking of one or more parts of the body</li><li>Increased sweating</li><li>Pain</li><li>Altered sense of taste</li><li>Feeling tired all the time, or feeling sleepy</li><li>Shortness of breath</li></ul><p>Uncommon (may affect up to 1 in 100 people)</p><ul><li>Breathing difficult and triggers coughing, a whistling sound (wheezing) when you breathe out, and shortness of breath (asthma)</li><li>Allergic reaction</li><li>Swelling in the hands, feet, ankles, legs</li><li>Swelling of the skin</li><li>Indigestion</li><li>Belly pain</li><li>Constant feeling of being tired</li><li>Sore or irritated throat</li><li>Painful and abnormal contractions of the throat</li><li>Mouth irritation</li><li>Mouth pain or discomfort in the back of the mouth</li><li>Pain in the cheek, gums, lips, chin</li><li>Loss of strength and energy, feeling weak</li><li>Feeling of uneasiness, overall feeling of being sluggish</li><li>Burning sensation</li><li>Scratch or damage to the skin</li><li>Changes in body temperature</li><li>Decrease in a type of white blood cell shown in tests</li><li>Feeling drowsy</li><li>Feeling dizzy</li><li>Pain in joints</li><li>Pain in the area between the hip and rib</li><li>Muscle fatigue</li><li>Increased rigidity of muscles</li><li>Cannot hold or maintain balance</li><li>Low blood pressure</li><li>Feeling of near fainting</li><li>Pain in one or both sides of the head, throbbing pain, aura, eye pain, sensitivity to light (migraine)</li><li>Skin discolouration</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 pombiliti" ] ; 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 pombiliti" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Your doctor, pharmacist, or nurse is responsible for storing this medicine and disposing of any opened vials correctly. The following information is intended for healthcare professionals.</p><p>Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the bottle and carton after the letters EXP . The expiry date refers to the last date of that month. Unopened vials: Store in the refrigerator (2 C - 8 C). Keep the vial in the outer carton in order to protect from light. After dilution, an immediate use is recommended. However, storage of the intravenous bag with Pombiliti has been demonstrated for 6 hours at 20 C - 25 C and 24 hours at 2 C - 8 C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that you no longer use. These measures will help protect the environment.</p></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 Pombiliti contains The active substance is cipaglucosidase alfa. One vial contains 105 mg of cipaglucosidase alfa. After reconstitution, the solution in the vial contains 15 mg of cipaglucosidase alfa per mL. The recommended final concentration of cipaglucosidase alfa diluted into the intravenous bag ranges from 0.5 mg/mL to 4 mg/mL.</p><p>The other ingredients are:</p><ul><li>Sodium citrate dihydrate (E331)</li><li>Citric acid monohydrate (E330)</li><li>Mannitol (E421)</li><li>Polysorbate 80 (E433)</li></ul><p>What Pombiliti looks like and contents of the pack</p><p>Pombiliti is a white to slightly yellowish powder. After reconstitution, it appears as a clear to opalescent, colourless to slightly yellow solution, free of foreign particles, practically free of particles in the form of white to translucent particles. The reconstituted solution must be further diluted into an intravenous bag for infusion.</p><p>Pombiliti is a powder for concentrate for solution for infusion in a vial</p><p>Packs of 1 vial, 10 vials, or 25 vials</p><p>Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder</p><p>Amicus Therapeutics Europe Limited Block 1, Blanchardstown Corporate Park Ballycoolin Road Blanchardstown, Dublin D15 AKK1 Ireland Tel: +353 (0) 1 588 0Fax: +353 (0) 1 588 6e-mail: <a href=\"mailto:info@amicusrx.co.uk\">info@amicusrx.co.uk</a></p><p>Manufacturer Manufacturing Packaging Farmaca (MPF) B.V. Neptunus 12, Heerenveen, 8448CN, Netherlands</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien Amicus Therapeutics Europe Limited T l/Tel: (+32) 0800 89e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Lietuva Amicus Therapeutics Europe Limited<br/>Tel: (+370) 8800 33El. pa tas: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Amicus Therapeutics Europe Limited<br/>Te .: (+359) 00800 111 3 : <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Luxembourg/Luxemburg Amicus Therapeutics Europe Limited<br/>T l/Tel: (+352) 800 27e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a> esk republika Amicus Therapeutics Europe Limited<br/>Tel.: (+420) 800 142 e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Magyarorsz g Amicus Therapeutics Europe Limited<br/>Tel.: (+36) 06 800 21e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a> Danmark Amicus Therapeutics Europe Limited<br/>Tlf.: (+45) 80 253 e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Malta Amicus Therapeutics Europe Limited<br/>Tel: (+356) 800 62e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Deutschland Amicus Therapeutics GmbH Tel: (+49) 0800 000 2E-Mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Nederland Amicus Therapeutics BV Tel: (+31) 20 235 8510 / (+31) 0800 022 8e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a> Eesti Amicus Therapeutics Europe Limited<br/>Tel: (+372) 800 0111 e-post: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Norge Amicus Therapeutics Europe Limited<br/>Tlf: (+47) 800 13e-post: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Amicus Therapeutics Europe Limited<br/>: (+30) 00800 126 e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>sterreich Amicus Therapeutics Europe Limited<br/>Tel: (+43) 0800 909 E-Mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a> Espa a Amicus Therapeutics S.L.U. Tel: (+34) 900 941 e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Polska Amicus Therapeutics Europe Limited<br/>Tel.: (+48) 0080 012 15e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a> France Amicus Therapeutics SAS T l: (+33) 0 800 906 e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Portugal Amicus Therapeutics Europe Limited<br/>Tel: (+351) 800 812 e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a> Hrvatska Amicus Therapeutics Europe Limited<br/>Tel: (+358) 0800 222 e-po ta: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Ireland Rom nia Amicus Therapeutics Europe Limited<br/>Tel.: (+40) 0808 034 e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Slovenija Amicus Therapeutics Europe Limited<br/>Tel: (+353) 1800 936 e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Amicus Therapeutics Europe Limited<br/>Tel.: (+386) 0800 81e-po ta: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>sland Amicus Therapeutics Europe Limited<br/>S mi: (+354) 800 7Netfang: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a> Slovensk republika Amicus Therapeutics Europe Limited<br/>Tel: (+421) 0800 002 e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Italia Amicus Therapeutics S.r.l. Tel: (+39) 800 795 e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Suomi/Finland Amicus Therapeutics Europe Limited<br/>Puh/Tel: (+358) 0800 917 s hk posti/e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Amicus Therapeutics Europe Limited<br/>: (+357) 800 97e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Sverige Amicus Therapeutics Europe Limited<br/>Tfn: (+46) 020 795 e-post: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>Latvija Amicus Therapeutics Europe Limited<br/>Tel: (+371) 800 05e-pasts: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>United Kingdom (Northern Ireland) Amicus Therapeutics, UK Limited<br/>Tel: (+44) 08 0823 46e-mail: <a href=\"mailto:MedInfo@amicusrx.com\">MedInfo@amicusrx.com</a></p><p>This leaflet was last revised in</p><p>Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>" ] ] ) ] ) . # <MedicinalProductDefinition/mp639cce8c495cbcbb29789688f0c06663> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "mp639cce8c495cbcbb29789688f0c06663"] ; # 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_mp639cce8c495cbcbb29789688f0c06663\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mp639cce8c495cbcbb29789688f0c06663</b></p><a name=\"mp639cce8c495cbcbb29789688f0c06663\"> </a><a name=\"hcmp639cce8c495cbcbb29789688f0c06663\"> </a><a name=\"mp639cce8c495cbcbb29789688f0c06663-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/22/1714/001</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>: Pombiliti 105 mg powder for concentrate for solution for infusion</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}\">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}\">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}\">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 EU}\">EU</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 EU}\">EU</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 en}\">en</span></td></tr></table></blockquote></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU/1/22/1714/001" ] ] ) ; # 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 "Pombiliti 105 mg powder for concentrate for solution for infusion" ] ; 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
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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.
