FrancophonIA/ELRC3.0 huggingface dataset:
English: However, caution should be exercised when prescribing to elderly patients at doses higher than 10 mg vortioxetine once daily (see section 4.4).
Danish: 4.2), og der skal udvises forsigtighed ved ordination af doser over 10 mg vortioxetin en gang dagligt til ældre patienter (se pkt.
English: For information on undesirable effects, see section 4.8.
Danish: Vedrørende bivirkninger, se pkt.
English: Brintellix 10 mg film-coated tablets EU/1/13/891/008-017
Danish: Brintellix 10 mg filmovertrukne tabletter EU/1/13/891/008-017
English: Multipack containing 490 (5 x (98x1)) film-coated tablets.
Danish: Flerstykspakning med 490 (5 x (98x1)) filmovertrukne tabletter.
English: Fits are a potential risk with medicines used to treat depression.
Danish: Lægemidler mod depression er forbundet med en risiko for at få kramper.
English: Brintellix 15 mg film-coated tablets Blister: Transparent; PVC/PVdC/aluminium blister.
Danish: Brintellix 5 mg filmovertrukne tabletter Blister: Transparent PVC/PVdC/Al-blister Pakninger a 14, 28 og 98 filmovertrukne tabletter.
English: Brintellix 20 mg film-coated tablets
Danish: Brintellix 20 mg filmovertrukne tabletter
English: Treatment should be discontinued in any patient who develops fits or where there is an increase in the frequency of fits.
Danish: Behandlingen bør afbrydes hos patienter, der oplever kramper eller får kramper hyppigere end normalt.
English: Depending on individual patient response, a dose adjustment of vortioxetine may be considered if a broad cytochrome P450 inducer (e.g., rifampicin, carbamazepine, phenytoin) is added to vortioxetine treatment (see section 4.5).
Danish: Afhængigt af den enkelte patients respons kan det overvejes at justere dosis af vortioxetin, hvis en bred CYP-induktor (f.eks. rifampicin, carbamazepin, phenytoin) føjes til behandling med vortioxetin (se pkt.
English: No effect on the pharmacokinetics of vortioxetine or ethanol and no significant impairment, relative to placebo, in cognitive function were observed when vortioxetine in a single dose of 20 mg or 40 mg was co-administered with a single dose of ethanol (0.6 g/kg) in healthy subjects.
Danish: Efter co-administration af en enkeltdosis af vortioxetin på 20 mg eller 40 mg og en enkeltdosis ethanol (0,6 g/kg) til raske forsøgspersoner observeredes ingen påvirkning af hverken vortioxetins eller ethanols farmakokinetik eller signifikant nedsættelse af kognitiv funktion sammenholdt med placebo.
English: Multipack: 490 (5 packs of 98 x 1) film-coated tablets.
Danish: Flerstykspakning: 490 (5 pakninger a 98 x 1) filmovertrukne tabletter.
English: However, the 20 mg dose of vortioxetine was associated with an increase in sexual dysfunction (TESD)(see section 5.1) .
Danish: Ved doser på 5-15 mg sås ingen afvigelser fra placebo, hvorimod en dosis på 20 mg vortioxetin var forbundet med en højere frekvens af seksuel dysfunktion (TESD) (se pkt.
English: Brintellix 20 mg film-coated tablets Blister: Transparent; PVC/PVdC/aluminium blister.
Danish: Brintellix 20 mg filmovertrukne tabletter Blister: Transparent PVC/PVdC/Al-blister Pakninger a 14, 28, 56 og 98 filmovertrukne tabletter.
English: Brintellix 10 mg film-coated tablets
Danish: Brintellix 10 mg filmovertrukne tabletter
English: Brintellix 15 mg film-coated tablets
Danish: Brintellix 15 mg filmovertrukne tabletter
English: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 20 mg vortioxetine.
Danish: En filmovertrukket tablet indeholder vortioxetinhydrobromid svarende til 20 mg vortioxetin (vortioxetine).
English: Brintellix 5 mg film-coated tablets
Danish: Brintellix 5 mg filmovertrukne tabletter
English: Brintellix 10 mg film-coated tablets vortioxetine
Danish: Brintellix 10 mg filmovertrukne tabletter vortioxetine
English: Package leaflet: Information for the patient Brintellix 20 mg film-coated tablets vortioxetine
Danish: Indlægsseddel: Information til patienten Brintellix 20 mg filmovertrukne tabletter
English: Brintellix 20 mg film-coated tablets vortioxetine
Danish: Brintellix 20 mg filmovertrukne tabletter vortioxetine
English: ECT (electroconvulsive therapy)
Danish: Vortioxetin (vortioxetine)
English: Each film-coated tablet contains 20 mg vortioxetine (as hydrobromide).
Danish: En filmovertrukket tablet indeholder 20 mg vortioxetine (som hydrobromid).
English: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 10 mg vortioxetine.
Danish: En filmovertrukket tablet indeholder vortioxetinhydrobromid svarende til 10 mg vortioxetin (vortioxetine).
English: Doses of 5 to 15 mg showed no difference to placebo.
Danish: 15 mg/dag administrationen adskilte sig ikke fra placebo i metaanalysen, men gennemsnitsforskellen fra placebo var -2,6 point.
English: Brintellix 15 mg film-coated tablets vortioxetine
Danish: Brintellix 15 mg filmovertrukne tabletter vortioxetine
English: Package leaflet: Information for the patient Brintellix 10 mg film-coated tablets vortioxetine
Danish: Indlægsseddel: Information til patienten Brintellix 10 mg filmovertrukne tabletter
English: Depending on individual patient response, a lower dose of vortioxetine may be considered if strong CYP2D6 inhibitor (e.g., bupropion, quinidine, fluoxetine, paroxetine) is added to vortioxetine treatment (see section 4.2).
Danish: Afhængigt af den enkelte patients respons kan det overvejes at give en lavere dosis vortioxetin ved tilføjelse af potente CYP2D6-hæmmere (f.eks. bupropion, quinidin, fluoxetin, paroxetin) til behandling med vortioxetin (se pkt.
English: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 15 mg vortioxetine.
Danish: En filmovertrukket tablet indeholder vortioxetinhydrobromid svarende til 15 mg vortioxetin (vortioxetine).
English: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 5 mg vortioxetine.
Danish: En filmovertrukket tablet indeholder vortioxetinhydrobromid svarende til 5 mg vortioxetin (vortioxetine).
English: Package leaflet: Information for the patient Brintellix 15 mg film-coated tablets vortioxetine
Danish: Indlægsseddel: Information til patienten Brintellix 15 mg filmovertrukne tabletter
English: Brintellix film-coated tablets 20 mg are available in blister packs of 14, 28, 56, 56x1, 98, 98x1, 126 (9x14), 490 (5x(98x1)) tablets and in tablet containers of 100, 200 tablets.
Danish: Brintellix filmovertrukne tabletter 20 mg fås i blisterpakninger med 14, 28, 56, 56x1, 98, 98x1, 126 (9x14), 490 (5x(98x1)) tabletter samt i beholdere med 100, 200 tabletter.
English: Package leaflet: Information for the patient Brintellix 5 mg film-coated tablets vortioxetine
Danish: Indlægsseddel: Information til patienten Brintellix 5 mg filmovertrukne tabletter
English: Orange, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “15” on the other side.
Danish: Orange, mandelformet (5 x 8,4 mm) filmovertrukket tablet præget med “TL” på den ene side og “15” på den anden side.
English: Red, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “20” on the other side.
Danish: Rød, mandelformet (5 x 8,4 mm) filmovertrukket tablet præget med “TL” på den ene side og “20” på den anden side.
English: Brintellix film-coated tablets 10 mg are available in blister packs of 7, 14, 28, 56, 56 x 1, 98, 98 x 1, 126 (9x14), 490 (5 x (98x1)) tablets and in tablet containers of 100 and 200 tablets.
Danish: Brintellix filmovertrukne tabletter 10 mg fås i blisterpakninger med 7, 14, 28, 56, 56 x 1, 98, 98 x 1 eller 126 (9x14), 490 (5 x (98x1)) tabletter samt i beholdere med 100 eller 200 tabletter.
English: Brintellix 5 mg film-coated tablets Vortioxetine
Danish: Brintellix 5 mg filmovertrukne tabletter vortioxetine
English: Red, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “20” on the other side.
Danish: Rød, mandelformet 5 x 8,4 mm filmovertrukket tablet (tablet) præget med “TL” på den ene side og “20” på den anden side.
English: Orange, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “15” on the other side.
Danish: Orange, mandelformet 5 x 8,4 mm filmovertrukket tablet (tablet) præget med “TL” på den ene side og “15” på den anden side.
English: EU/1/13/891/018 14 film-coated tablets EU/1/13/891/019 28 film-coated tablets EU/1/13/891/020 56 film-coated tablets EU/1/13/891/021 98 film-coated tablets EU/1/13/891/022 56x1 film-coated tablets EU/1/13/891/023 98x1 film-coated tablets EU/1/13/891/025 100 film-coated tablets EU/1/13/891/026 200 film-coated tablets
Danish: EU/1/13/891/01814 filmovertrukne tabletter EU/1/13/891/019 28 filmovertrukne tabletter EU/1/13/891/020 56 filmovertrukne tabletter EU/1/13/891/021 98 filmovertrukne tabletter EU/1/13/891/022 56 x 1 filmovertrukne tabletter EU/1/13/891/023 98 x 1 filmovertrukne tabletter EU/1/13/891/025 100 filmovertrukne tabletter EU/1/13/891/026 200 filmovertrukne tabletter
English: Each film-coated tablet contains 10 mg vortioxetine (as hydrobromide).
Danish: En filmovertrukket tablet indeholder 10 mg vortioxetine (som hydrobromid).
English: EU/1/13/891/001 14 film-coated tablets EU/1/13/891/002 28 film-coated tablets EU/1/13/891/003 56 x 1 film-coated tablets EU/1/13/891/004 98 x 1 film-coated tablets EU/1/13/891/006 100 film-coated tablets EU/1/13/891/007 200 film-coated tablets EU/1/13/891/037 98 film-coated tablets
Danish: EU/1/13/891/001 14 filmovertrukne tabletter EU/1/13/891/002 28 filmovertrukne tabletter EU/1/13/891/003 56 x 1 filmovertrukne tabletter EU/1/13/891/004 98 x 1 filmovertrukne tabletter EU/1/13/891/006 100 filmovertrukne tabletter EU/1/13/891/007 200 filmovertrukne tabletter EU/1/13/891/037 98 filmovertrukne tabletter
English: Brintellix film-coated tablets 15 mg are available in blister packs of 14, 28, 56, 56 x 1, 98, 98 x 1, 490 (5 x (98x1)) tablets and in tablet containers of 100 and 200 tablets.
Danish: Brintellix filmovertrukne tabletter 15 mg fås i blisterpakninger med 14, 28, 56, 56 x 1, 98, 98 x 1 eller 490 (5 x (98x1)) tabletter samt i beholdere med 100 eller 200 tabletter.
English: Yellow, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “10” on the other side.
Danish: Gul, mandelformet 5 x 8,4 mm filmovertrukket tablet (tablet) præget med “TL” på den ene side og “10” på den anden side.
English: AUTHORISATION
Danish: Indgivelsesmåde
English: Patients should be monitored for the emergence of signs and symptoms of SS or NMS (see sections 4.3 and 4.5).
Danish: Patienterne bør kontrolleres for symptomer på serotonergt syndrom og malignt neuroleptikasyndrom (se pkt.
English: Brintellix film-coated tablets 5 mg are available in blister packs of 14, 28, 98, 56x1, 98x1, 126 (9x14) 490 (5x(98x1)) tablets and in tablet containers of 100 and 200 tablets.
Danish: Brintellix filmovertrukne tabletter 5 mg fås i blisterpakninger med 14, 28, 98, 56x1, 98x1, 126 (9x14), 490 (5x (98x1)) tabletter samt i beholdere med 100 eller 200 tabletter.
English: Gastrointestinal disorders
Danish: CYP-induktorer
English: EU/1/13/891/027 14 film-coated tablets EU/1/13/891/028 28 film-coated tablets EU/1/13/891/029 56 film-coated tablets EU/1/13/891/030 98 film-coated tablets EU/1/13/891/031 56x1 film-coated tablets EU/1/13/891/032 98x1 film-coated tablets EU/1/13/891/034 100 film-coated tablets EU/1/13/891/035 200 film-coated tablets
Danish: EU/1/13/891/02714 filmovertrukne tabletter EU/1/13/891/028 28 filmovertrukne tabletter EU/1/13/891/029 56 filmovertrukne tabletter EU/1/13/891/030 98 filmovertrukne tabletter EU/1/13/891/031 56 x 1 filmovertrukne tabletter EU/1/13/891/032 98 x 1 filmovertrukne tabletter EU/1/13/891/034 100 filmovertrukne tabletter EU/1/13/891/035 200 filmovertrukne tabletter
English: EU/1/13/891/038 126 film-coated tablets (9 packs of 14) EU/1/13/891/005 490 film-coated tablets (5 packs of 98x1)
Danish: EU/1/13/891/038 126 filmovertrukne tabletter (9 pakninger a 14) EU/1/13/891/005 490 filmovertrukne tabletter (5 pakninger a 98 x 1)
English: Multipack: 490 (5 packs of 98x1) film-coated tablets.
Danish: Flerstykspakning: 490 (5 pakninger a 98 x1) filmovertrukne tabletter.
English: Pink, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “5” on the other side.
Danish: Lyserød, mandelformet (5 x 8,4 mm) filmovertrukket tablet præget med “TL” på den ene side og “5” på den anden side.
English: Brintellix 10 mg film-coated tablets Blister: Transparent; PVC/PVdC/aluminium blister.
Danish: Brintellix 10 mg filmovertrukne tabletter Blister: Transparent PVC/PVdC/Al-blister Pakninger a 7, 14, 28, 56 og 98 filmovertrukne tabletter.
English: Brintellix is not to be used during breast-feeding.
Danish: Du må ikke tage Brintellix, hvis du ammer.
English: EU/1/13/891/008 7 film-coated tablets EU/1/13/891/009 14 film-coated EU/1/13/891/010 28 film-coated tablets EU/1/13/891/011 56 film-coated tablets EU/1/13/891/012 98 film-coated tablets EU/1/13/891/013 56x1 film-coated tablets EU/1/13/891/014 98x1 film-coated tablets EU/1/13/891/016 100 film-coated tablets EU/1/13/891/017 200 film-coated tablets
Danish: EU/1/13/891/0087 filmovertrukne tabletter EU/1/13/891/009 14 filmovertrukne tabletter EU/1/13/891/010 28 filmovertrukne tabletter EU/1/13/891/011 56 filmovertrukne tabletter EU/1/13/891/012 98 filmovertrukne tabletter EU/1/13/891/013 56 x 1 filmovertrukne tabletter EU/1/13/891/014 98 x 1 filmovertrukne tabletter EU/1/13/891/016 100 filmovertrukne tabletter EU/1/13/891/017 200 filmovertrukne tabletter
English: Pink, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “5” on the other side.
Danish: Lyserød, mandelformet 5 x 8,4 mm filmovertrukket tablet (tablet) præget med “TL” på den ene side og “5” på den anden side.
English: Yellow, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “10” on the other side.
Danish: Gul, mandelformet (5 x 8,4 mm) filmovertrukket tablet præget med “TL” på den ene side og “10” på den anden side.
English: Each film-coated tablet contains 5 mg vortioxetine (as hydrobromide).
Danish: En filmovertrukket tablet indeholder 5 mg vortioxetine (som hydrobromid).
English: Each film-coated tablet contains 15 mg vortioxetine (as hydrobromide).
Danish: En filmovertrukket tablet indeholder 15 mg vortioxetine (som hydrobromid).
English: EU/1/13/891/040 126 film-coated tablets (9 packs of 14) EU/1/13/891/033 490 film-coated tablets (5 packs of 98x1)
Danish: EU/1/13/891/040126 filmovertrukne tabletter (9 pakninger a 14) EU/1/13/891/033 490 filmovertrukne tabletter (5 pakninger a 98 x 1)
English: EU/1/13/891/039 126 film-coated tablets (9 packs of 14) EU/1/13/891/015 490 film-coated tablets (5 packs of 98x1)
Danish: EU/1/13/891/039126 filmovertrukne tabletter (9 pakninger a 14) EU/1/13/891/015 490 filmovertrukne tabletter (5 pakninger a 98 x 1)
English: If you take more Brintellix than you should
Danish: Hvis du har taget for meget Brintellix
English: Depending on individual patient response, a lower dose of vortioxetine may be considered if a strong CYP2D6 inhibitor (e.g., bupropion, quinidine, fluoxetine, paroxetine) is added to vortioxetine treatment (see section 4.2).
Danish: Afhængigt af den enkelte patients respons kan det overvejes at give en lavere dosis vortioxetin ved samtidig behandling med potente CYP2D6-hæmmere (f.eks. bupropion, quinidin, fluoxetin, paroxetin) (se pkt.
English: It was to be available as tablets (100 mg and 400 mg).
Danish: Det var hensigten, at det skulle leveres som tabletter (100 mg og 400 mg).
English: What is Ruvise?
Danish: Hvad er Ruvise?
English: The applicant presented data from one main study involving 202 patients with PAH.
Danish: Ansøgeren fremlagde data fra én hovedundersøgelse, hvori der deltog 202 patienter med PAH.
English: The Committee was concerned that a beneficial effect of imatinib in PAH had not been sufficiently demonstrated.
Danish: Udvalget var betænkeligt ved, at den gavnlige virkning af imatinib ved PAH ikke var tilstrækkeligt bevist.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med Ruvise og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
English: It was expected to be used in patients who still have symptoms despite being treated with at least two medicines specific for PAH.
Danish: Det forventedes anvendt hos patienter, der fortsat har symptomer, selv om de er i behandling med mindst to særlige lægemidler mod PAH.
English: The Committee also noted the higher unexplained risk of subdural haemorrhage (a type of bleeding in the brain).
Danish: Udvalget bemærkede desuden den uforklarede højere risiko for subdural blødning (en form for blødning i hjernen).
English: Treatment with Ruvise was only to be started in patients who do not show a rapid progression of their disease.
Danish: Behandlingen med Ruvise skulle kun iværksættes hos patienter, hos hvem sygdommen ikke skrider hurtigt frem.
English: Medicines containing imatinib are currently approved in the European Union (EU) for the treatment of different types of cancers.
Danish: Lægemidler indeholdende imatinib er på nuværende tidspunkt godkendt i EU til behandling af forskellige kræfttyper.
English: Withdrawal of the marketing authorisation application for Ruvise (imatinib)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Ruvise (imatinib)
English: On 17 January 2013 Novartis Europharm Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ruvise, for the treatment of pulmonary arterial hypertension.
Danish: Den 17. januar 2013 meddelte Novartis Europharm Ltd officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Ruvise til behandling af pulmonal arteriel hypertension.
English: Ruvise is a medicine that contains the active substance imatinib.
Danish: Ruvise er et lægemiddel, der indeholder det aktive stof imatinib.
English: What was Ruvise expected to be used for?
Danish: Hvad forventedes Ruvise anvendt til?
English: Withdrawal of the marketing authorisation application for Ruvise (imatinib) EMA/38204/2013
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Ruvise (imatinib) EMA/38204/2013
English: Data showed only a limited and variable improvement in the distance that patients could walk during the walk test.
Danish: Dataene viste kun en begrænset og varierende forbedring i den afstand, patienterne kunne gå i gangtesten.
English: Furthermore, imatinib-treated PAH patients had a higher risk of serious side effects, often leading to hospitalisation during early treatment, and long-term follow-up showed no significant improvement in terms of survival or delaying the worsening of symptoms.
Danish: Desuden havde de patienter, der blev behandlet med imatinib, større risiko for alvorlige bivirkninger, der ofte medførte indlæggelse i begyndelsen af behandlingen, og langtidsopfølgningen viste ingen væsentlig bedring i overlevelse eller i forsinkelse af forværringen af symptomerne.
English: How is Ruvise expected to work?
Danish: Hvordan forventes Ruvise at virke?
English: This means that it blocks some specific enzymes known as tyrosine kinases, which are involved in stimulating cells to divide.
Danish: Det vil sige, at stoffet blokerer nogle særlige enzymer, der kaldes tyrosinkinaser, som medvirker ved stimulering af cellernes deling.
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Ruvise?
English: EMA/38204/2013
Danish: Den 21. februar 2013 EMA/38204/2013
English: In the study, patients were given either imatinib or placebo (a dummy treatment), added to two or more PAH medicines, for 24 weeks.
Danish: I undersøgelsen fik patienterne i en periode af 24 uger enten imatinib eller placebo (virkningsløs behandling) som tillægsbehandling til to eller flere lægemidler mod PAH.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated two rounds of questions.
Danish: Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, virksomheden havde indsendt, og stillet spørgsmål i to runder.
English: Imatinib is a tyrosine-kinase inhibitor.
Danish: Imatinib er en tyrosinkinasehæmmer.
English: In view of the serious side effects observed in some PAH patients, the CHMP considered that more data were needed to identify which patients were at particular risk.
Danish: På baggrund af de alvorlige bivirkninger, der var iagttaget hos nogle PAH-patienter, fandt CHMP, at det var nødvendigt med flere data for at udpege de patienter, der var særligt udsat.
English: This withdrawal has no impact on the use of other imatinib containing medicines in cancer.
Danish: Denne tilbagetrækning har ingen konsekvenser for kræftbehandling med andre lægemidler, der indeholder imatinib.
English: The company informed the CHMP that on-going PAH extension studies are continuing.
Danish: Virksomheden har til CHMP oplyst, at den fortsætter de igangværende forlængede undersøgelser vedrørende PAH.
English: The main measure of effectiveness was the distance that patients could walk during a six-minute walk test.
Danish: Virkningen blev hovedsagelig bedømt på, hvor langt patienterne kunne gå i en seks minutters gangtest.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ruvise could not be approved for the treatment of PAH.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's spørgsmål havde CHMP på tidspunktet for tilbagetrækningen af ansøgningen visse betænkeligheder og var af den foreløbige opfattelse, at Ruvise ikke kunne godkendes til behandling af PAH.
English: Ruvise was expected to be used as an add-on treatment in adults with pulmonary arterial hypertension (PAH, high blood pressure in the arteries of the lungs) to improve exercise capacity (the ability to carry out physical activity).
Danish: Ruvise forventedes anvendt som tillægsbehandling hos voksne med pulmonal arteriel hypertension (PAH, for højt blodtryk i lungearterierne) til at forbedre den fysiske kapacitet.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Ruvise did not outweigh its risks in the PAH population.
Danish: På tidspunktet for tilbagetrækningen var CHMP derfor af den opfattelse, at fordelene ved Ruvise ikke var større end risiciene for patienter med PAH.
English: By blocking this action, Ruvise is expected to make it easier for the blood to flow through the arteries of the lungs, thereby lowering the high blood pressure in the lungs.
Danish: Ruvise blokerer denne virkning og forventes derfor at lette blodets gennemstrømning i arterierne i lungerne, så det høje blodtryk i lungerne sænkes.
English: In the blood vessel cells in the lungs, this action of the tyrosine kinases contributes to the narrowing of blood vessels leading to high blood pressure.
Danish: I cellerne i lungernes blodkar er denne virkning af tyrosinkinaserne med til at forsnævre blodkarrene, hvilket medfører forhøjet blodtryk.
English: In its official letter, the company stated that its decision to withdraw the application was based on the fact that the additional data required to address CHMP's questions could not be made available within the regulatory timeframe.
Danish: fordi de supplerende data, der er nødvendige til besvarelse af CHMP's spørgsmål, ikke kunne fremskaffes inden for den forskriftsmæssige frist.
English: Strength Pharmaceutical Form Route of Administration Immediate Packaging
Danish: Styrke Lægemiddelform Administration Emballage Pakningsstørrelse
English: MA (EU) Number Name
Danish: MF (EU)-nummer
English: Pack size
Danish: Navn
English: In the EU, Zydelig is authorised for the treatment of:
Danish: I EU er Zydelig godkendt til behandling af:
English: It is only used in combination with rituximab.
Danish: Det bruges kun i kombination med rituximab.