FrancophonIA/ELRC3.0 huggingface dataset:
English: Taken together, the in vitro data suggest ambrisentan at clinically relevant concentrations (plasma Cmax up to 3.2 μM) would not be expected to have an effect on UGT1A1, UGT1A6, UGT1A9, UGT2B7 or cytochrome P450 enzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4 or transport via BSEP, BCRP, Pgp, MRP2, OATP1B1/3, or NTCP.
Danish: Samlet set antyder in vitro data, at ambrisentan ikke kan forventes at have en effekt på UGT1A1, UGT1A6, UGT1A9, UGT2B7 eller CYP-enzymerne 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4 eller transport via BSEP, BCRP, Pgp, MRP2, OATP1B1/3 eller NTCP ved klinisk relevante koncentrationer (plasma-Cmax op til 3,2 µM).
English: Immune system disorders Hypersensitivity reactions (e.g. angioedema, rash, pruritus)
Danish: Overfølsomhedsreaktioner (f.eks angioødem, udslæt, kløe)
English: Very common2
Danish: Meget almindelig2
English: The placebo-adjusted improvement in mean 6MWD at week 12 in patients in the 10 mg group in ARIES-1 was 51.4 m (95% CI: 26.6 to 76.2; p <0.001).
Danish: For 10 mg-gruppen i ARIES-1 var den placebojusterede forbedring i middel-6MWD efter 12 uger 51,4 m (95 % CI: 26,6 to 76,2; p < 0,001).
English: Other side effects include Very common side effects:
Danish: Meget almindelige bivirkninger:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg ambrisentan
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 10 mg ambrisentan
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 April 2008
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: The effect of 7-day dosing of sildenafil (20 mg three times daily) on the pharmacokinetics of a single dose of ambrisentan, and the effects of 7-day dosing of ambrisentan (10 mg once daily) on the pharmacokinetics of a single dose of sildenafil were investigated in 19 healthy volunteers.
Danish: Virkningen af 7 dages indgift af sildenafil (20 mg tre gange daglig) på farmakokinetikken af en enkelt dosis ambrisentan, og virkningen af 7 dages indgift af ambrisentan (10 mg en gang daglig) på farmakokinetikken ved en enkelt dosis sildenafil blev undersøgt hos 19 raske frivillige.
English: Ambrisentan was not shown to be an inhibitor of bile acid transport or to produce overt hepatotoxicity.
Danish: Det er ikke vist, at ambrisentan hæmmer galdesyretransporten eller er åbenlyst hepatotoksisk
English: If you take too many tablets you may be more likely to have side effects, such as headache, flushing, dizziness, nausea (feeling sick), or low blood pressure that could cause light-headedness: → Ask your doctor or pharmacist for advice if you take more tablets than prescribed.
Danish: Hvis du tager for mange Volibris-tabletter, er der større risiko for, at du får bivirkninger, såsom hovedpine, ansigtsrødme, svimmelhed, kvalme eller lavt blodtryk, som kan forårsage svimmelhed.
English: This is a very common side effect that may affect more than one in 10 people
Danish: Dette er en meget almindelig bivirkning, der kan forekomme hos flere end 1 ud af 10 patienter.
English: Volibris 10 mg film-coated tablet (tablet) is a deep pink, oval, convex tablet engraved with ‘GS' on one face and ‘KE3' on the other.
Danish: Volibris 10 mg filmovertrukket tablet (tablet) er en mørk pink, oval, konveks tablet, der er præget ”GS” på den ene side og ”KE3” på den anden.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg ambrisentan
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 5 mg ambrisentan
English: • if you are breast feeding.
Danish: • hvis du ammer.
English: In placebo controlled clinical trials of 12 weeks duration mean reduction in systolic and diastolic blood pressures from base line to end of treatment were 3mm Hg and 4.2 mm Hg respectively.
Danish: I placebokontrollerede kliniske studier af 12 ugers varighed var det gennemsnitlige systoliske og diastoliske blodtryksfald fra baseline til afslutning af behandlingen på hhv. 3 mm Hg og 4,2 mm Hg. Middelfaldene i det systoliske og diastoliske blodtryk blev opretholdt i op til 4 år under behandling med ambrisentan i det langvarige, ublindede ARIES-E-studie.
English: Deep-pink, oval, convex, film-coated tablet with “GS” debossed on one side and “KE3” on the other side.
Danish: Dyb pink, oval, konveks, filmovertrukket tablet, der er præget ”GS” på den ene side og ”KE3” på den anden side.
English: Check with your doctor or pharmacist if you're not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: 7 The incidence of nasal congestion was dose related during ambrisentan therapy.
Danish: 7 Hyppigheden af tilstoppet næse under behandling med ambrisentan var dosisafhængig.
English: The placebo-adjusted improvement in mean 6MWD at week 12 compared to baseline was 30.6 m (95% CI: 2.9 to 58.3; p=0.008) and 59.4 m (95% CI: 29.6 to 89.3; p<0.001) for the 5 mg group, in
Danish: For 5 mg-gruppen i ARIES-1 og -2 var den placebojusterede forbedring i middel-6MWD efter 12 uger henholdsvis 30,6 m (95 % CI: 2,9 til 58,3; p = 0,008) og 59,4 m (95 % CI: 29,6 til 89,3; p < 0,001) sammenlignet med baseline.
English: The effects of steady-state ambrisentan (10 mg once daily) on the pharmacokinetics and pharmacodynamics of a single dose of warfarin (25 mg), as measured by PT and INR, were investigated in 20 healthy volunteers.
Danish: Virkningen af steady state ambrisentan (10 mg en gang daglig) på farmakokinetikken og farmakodynamikken af en enkelt dosis warfarin (25 mg) (målt vha. PT og INR) blev undersøgt hos 20 raske frivillige.
English: In combination with tadalafil • sudden hearing loss.
Danish: I kombination med tadalafil • pludseligt høretab
English: Volibris 5 mg film-coated tablet (tablet) is a pale pink, square, convex tablet engraved with ‘GS' on one face and ‘K2C' on the other.
Danish: Volibris 5 mg filmovertrukket tablet (tablet) er en svag pink, firkantet, konveks tablet, der er præget ”GS” på den ene side og ”K2C” på den anden.
English: Marketing Authorisation Holder GlaxoSmithKline (Ireland) Limited 12 Riverwalk
Danish: Indehaver af markedsføringstilladelsen GlaxoSmithKline (Ireland) Limited 12 Riverwalk
English: adverse event frequency), compared to the incidence of anaemia when ambrisentan and tadalafil were given as monotherapy (7% and 11%, respectively).
Danish: Incidencen af anæmi var øget, når ambrisentan blev givet i kombination med tadalafil (bivirkningshyppighed 15 %) sammenlignet med incidencen af anæmi, når ambrisentan og tadalafil blev givet som monoterapi (henholdsvis 7 % og 11 %).
English: → Tell your doctor immediately.
Danish: Hvis du får nogen af disse symptomer: → Fortæl det straks til lægen.
English: Ambrisentan also undergoes oxidative metabolism mainly by CYP3A4 and to a lesser extent by CYP3A5 and CYP2C19 to form 4-hydroxymethyl ambrisentan (21%) which is further glucuronidated to 4-hydroxymethyl ambrisentan glucuronide (5%).
Danish: Ambrisentan gennemgår også oxidativ metabolisme hovedsagelig vha CYP3A4 og i mindre grad CYP3A5 og CYP2C19.
English: The effects of steady-state ambrisentan (10 mg once daily) on the pharmacokinetics of a single dose of tadalafil, and the effects of steady-state tadalafil (40 mg once daily) on the pharmacokinetics of a single dose of ambrisentan were studied in 23 healthy volunteers.
Danish: Virkningen af ambrisentan ved steady state (10 mg en gang daglig) på farmakokinetikken af en enkeltdosis tadalafil, og virkningen af tadalafil ved steady state (40 mg en gang daglig) på farmakokinetikken ved en enkeltdosis ambrisentan blev undersøgt hos 23 raske frivillige.
English: Monotherapy pooled
Danish: Monoterapi puljede
English: In ARIES-2, ambrisentan (combined dose group) significantly delayed the time to clinical worsening of PAH compared to placebo (p<0.001), the hazard ratio demonstrated an 80% reduction (95% CI: 47% to 92%).
Danish: ARIES-2 viste, at ambrisentan (kombineret dosis-gruppe) i signifikant grad udsatte tiden til klinisk forværring af PAH sammenlignet med placebo (p < 0,001).
English: Volibris 10 mg film-coated tablets
Danish: Volibris 10 mg filmovertrukne tabletter
English: Separate one tablet: tear along the cutting lines to separate one “pocket” from the strip.
Danish: Udtag en tablet: Riv én blister af langs skæringslinjen.
English: → If it is possible you could become pregnant, use a reliable form of birth control (contraception) while you're taking Volibris.
Danish: → Du skal bruge en sikker præventionsform, hvis der er mulighed for, at du kan blive gravid, mens du er i behandling med Volibris.
English: Pale-pink, square, convex, film-coated tablet with “GS” debossed on one side and “K2C” on the other side.
Danish: Svag pink, firkantet, konveks, filmovertrukket tablet, der er præget ”GS” på den ene side og ”K2C” på den anden side.
English: Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.4 and 5.2).
Danish: Patienter, som er i ambrisentanbehandling skal nøje overvåges, når behandling med rifampicin påbegyndes (se pkt.
English: Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.4 and 4.5).
Danish: Patienter, som er i ambrisentanbehandling, skal nøje overvåges, når behandling med rifampicin påbegyndes (se pkt.
English: GlaxoSmithKline (Cyprus) Ltd Τηλ: + 357 22 39 70 00 gskcyprus@gsk.com
Danish: GlaxoSmithKline (Cyprus) Ltd Τηλ: + 357 22 39 70 00
English: Volibris 5 mg film-coated tablets
Danish: Volibris 5 mg filmovertrukne tabletter
English: → If you become pregnant or think that you may be pregnant while you're taking Volibris, see your doctor immediately.
Danish: → Du skal omgående kontakte lægen, hvis du bliver gravid eller har mistanke om, at du er gravid, mens du er i behandling med Volibris.
English: Ambrisentan does not inhibit or induce phase I or II drug metabolising enzymes at clinically relevant concentrations in in vitro and in vivo non-clinical studies, suggesting a low potential for ambrisentan to alter the profile of medicinal products metabolised by these pathways.
Danish: In vitro- og in vivo- non-kliniske undersøgelser har vist at ambrisentan hverken hæmmer eller fremmer fase I- eller II-lægemiddelmetaboliserende enzymer ved klinisk relevante koncentrationer.
English: → Contact your doctor before taking Volibris.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Volibris, hvis du har:
English: A.
Danish: IR
English: If you have been told by your doctor that you have an intolerance to some sugars:
Danish: Hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter: → Kontakt lægen, inden du tager Volibris.
English: The effects of acute and repeat dosing of rifampicin (600 mg once daily) on the steady-state pharmacokinetics of ambrisentan (10 mg once daily) were studied in healthy volunteers.
Danish: Virkningen på steady state-farmakokinetikken af ambrisentan (10 mg en gang daglig) efter akut og gentagne doser rifampicin (600 mg en gang daglig) er undersøgt hos raske frivillige personer.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/451/003 10 film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/451/003
English: Ambrisentan
Danish: Amning
English: Eye disorders Blurred vision, visual impairment Not known4
Danish: Øjne Sløret syn, nedsat syn
English: Volibris 5 mg film-coated tablets Volibris 10 mg film-coated tablets
Danish: Volibris 5 mg filmovertrukne tabletter Volibris 10 mg filmovertrukne tabletter ambrisentan
English: Peel back the outer layer: starting at the coloured corner, lift and peel over the pocket.
Danish: Fjern det yderste lag: Begynd ved det farvede hjørne.
English: The Cmax and AUC(0-τ) of ambrisentan increased (48% and 121%, respectively) in the presence of multiple doses of cyclosporine A. Based on these changes, the dose of ambrisentan should be limited to 5 mg once daily when co-administered with cyclosporine A (see section 4.2).
Danish: Cmax og AUC(0-t) for ambrisentan blev forøget (henholdsvis 48 % og 121 %) ved samtidig administration af flere doser ciclosporin.
English: If you take more Volibris than you should
Danish: Hvis du har taget for meget Volibris
English: NAME OF THE MEDICINAL PRODUCT Volibris 10 mg tablets ambrisentan
Danish: LÆGEMIDLETS NAVN Volibris 10 mg tabletter ambrisentan
English: GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com
Danish: GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00
English: NAME OF THE MEDICINAL PRODUCT Volibris 5 mg tablets ambrisentan
Danish: LÆGEMIDLETS NAVN Volibris 5 mg tabletter ambrisentan
English: However, there was no clinically relevant effect on ambrisentan exposure by day 8, following administration of multiple doses of rifampicin.
Danish: Efter administration af adskillige doser rifampicin var der dog ingen klinisk relvant virkning på ambrisentan-eksponeringen på dag 8.
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Magnesium stearate
Danish: Mikrokrystallinsk cellulose
English: Ambrisentan has not been studied in a sufficient number of patients to establish the benefit/risk balance in WHO functional class I PAH.
Danish: Risk/benefit-profilen for ambrisentan kan ikke fastslås hos patienter med PAH WHO-funktionsklasse I, da ambrisentan ikke er undersøgt hos et tilstrækkeligt antal af disse patienter.
English: Teratogenicity is a suspected class effect of ERAs.
Danish: Der er mistanke om, at alle ERA er teratogene.
English: Across the 12 week placebo controlled Phase 3 clinical studies, mean haemoglobin concentrations decreased for patients in the ambrisentan groups and were detected as early as week 4 (decrease by 0.83 g/dL); mean changes from baseline appeared to stabilise over the subsequent 8 weeks.
Danish: Igennem de 12 ugers placebokontrollerede fase 3-studier faldt middelhæmoglobinkoncentrationerne for patienterne i ambrisentan-grupperne.
English: That women of reproductive potential must use effective contraception; The need for monthly pregnancy tests;
Danish: at Volibris er teratogent hos dyr at gravide kvinder ikke må tage Volibris at fertile kvinder skal anvende effektiv prævention behovet for månedlige graviditetstests behovet for regelmæssig overvågning af leverfunktionen, da Volibris kan forårsage leverskade.
English: Lecithin (soya) (E322) Allura red AC Aluminium Lake (E129)
Danish: Allura Red AC (E129)
English: 9 Rash includes rash erythematous, rash generalised, rash papular and rash pruritic
Danish: 9 Udslæt inkluderer erytematøst udslæt, generaliseret udslæt, papuløst udslæt og kløende udslæt.
English: What Volibris is and what it is used for What you need to know before you take Volibris How to take Volibris
Danish: Det skal du vide, før du begynder at tage Volibris Sådan skal du tage Volibris Bivirkninger
English: NAME OF THE MEDICINAL PRODUCT Volibris 5 mg film-coated tablets ambrisentan
Danish: LÆGEMIDLETS NAVN Volibris 5 mg filmovertrukne tabletter ambrisentan
English: If a patient is hypersensitive to soya, ambrisentan must not be used (see section 4.3).
Danish: Volibris-tabletter indeholder sojalecithin og må ikke anvendes til patienter med overfølsomhed over for soja (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Volibris 10 mg film-coated tablets ambrisentan
Danish: LÆGEMIDLETS NAVN Volibris 10 mg filmovertrukne tabletter ambrisentan
English: Volibris 5 mg film-coated tablets Each tablet contains 5 mg of ambrisentan.
Danish: Hver tablet indeholder 5 mg ambrisentan.
English: ARIES 1 and 2 respectively.
Danish: 4.4 og 5.2).
English: Cyclosporine A
Danish: Ciclosporin
English: Volibris 10 mg film-coated tablets Each tablet contains 10 mg of ambrisentan.
Danish: Hver tablet indeholder 10 mg ambrisentan.
English: Package leaflet: Information for the user Volibris 5 mg film-coated tablets Volibris 10 mg film-coated tablets ambrisentan
Danish: LÆGEMIDLETS NAVN Volibris 5 mg filmovertrukne tabletter Volibris 10 mg filmovertrukne tabletter
English: Combination with tadalafil
Danish: Kombination med tadalafil (AMBITION)
English: How to store Volibris
Danish: Brug af anden medicin sammen med Volibris
English: 4 Data derived from routine pharmacovigilance surveillance 5 Most of the reported cases of cardiac failure were associated with fluid retention.
Danish: 5 De fleste tilfælde af hjerteinsufficiens var forbundet med væskeretention.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/451/001 10 film-coated tablets EU/1/08/451/002 30 film-coated tablets 13.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/451/001
English: What Volibris looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Vial (glass) 2 ml (150 mg/ml) 2 (2 X 1) vials + 2 (2 X 1) syringes + 4 (2
Danish: 2 ml (150 mg/ml) 1 hætteglas + 1 sprøjte + 2 kanyler
English: EU (MA) Number (Invented) name Strength Pharmaceutical Form
Danish: MF (EU)-nummer
English: It is available as tablets (5mg).
Danish: Det leveres som tabletter (5 mg).
English: The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day.
Danish: Den anbefalede dosis til voksne og unge (12 år og derover) er 5 mg en gang dagligt.
English: The full EPAR for Desloratadine ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Desloratadine ratiopharm findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Desloratadine ratiopharm on 13 January 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Desloratadine ratiopharm den 13. januar 2012.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Desloratadine ratiopharm.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Desloratadine ratiopharm.
English: This is a summary of the European public assessment report (EPAR) for Desloratadine ratiopharm.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Desloratadine ratiopharm.
English: For more information about treatment with Desloratadine ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Desloratadine ratiopharm, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Desloratadine ratiopharm is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Danish: Desloratadine ratiopharm anvendes til lindring af symptomer på allergisk rhinitis (betændelse i næsepassagerne, som forårsages af allergi, f.eks. høfeber eller allergi over for støvmider) eller urticaria (en hudlidelse forårsaget af allergi med symptomer som bl.a. kløe og nældefeber).
English: The CHMP concluded that, in accordance with EU requirements, Desloratadine ratiopharm has been shown to have comparable quality and to be bioequivalent to Aerius.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Desloratadine ratiopharm er af sammenlignelig kvalitet og er bioækvivalent med Aerius.
English: This means that Desloratadine ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aerius.
Danish: Det betyder, at Desloratadine ratiopharm er identisk med et referencelægemiddel, der allerede er godkendt i Den Europæiske Union, kaldet Aerius.
English: Therefore, the CHMP's view was that, as for Aerius, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Aerius.
English: EPAR summary for the public desloratadine
Danish: EPAR - sammendrag for offentligheden desloratadin
English: When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Danish: Når receptorerne blokeres, mister histaminet sin virkning, og allergisymptomerne mindskes.
English: The Committee recommended that Desloratadine ratiopharm be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Desloratadine ratiopharm.
English: The active substance in Desloratadine ratiopharm, desloratadine, is an antihistamine.
Danish: Det aktive stof i Desloratadine ratiopharm, desloratadin, er et antihistamin.
English: It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms,
Danish: Det virker ved at blokere de receptorer, som histamin (et stof i kroppen, der fremkalder allergiske symptomer) normalt binder sig til.
English: Because Desloratadine ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Desloratadine ratiopharm er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Desloratadine ratiopharm is a medicine containing the active substance desloratadine.
Danish: Desloratadine ratiopharm er et lægemiddel, der indeholder det aktive stof desloratadin.
English: Desloratadine ratiopharm is a ‘generic medicine'.
Danish: Desloratadine ratiopharm er et ‘generisk lægemiddel'.
English: Because Desloratadine ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aerius.
Danish: Da Desloratadine ratiopharm er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Aerius.
English: What are the benefits and risks of Desloratadine ratiopharm?
Danish: Hvilken fordel og risiko er der forbundet med Desloratadine ratiopharm?
English: Other information about Desloratadine ratiopharm
Danish: Andre oplysninger om Desloratadine ratiopharm:
English: Why has Desloratadine ratiopharm been approved?
Danish: Hvorfor blev Desloratadine ratiopharm godkendt?
English: What is Desloratadine ratiopharm?
Danish: Hvad er Desloratadine ratiopharm?
English: How has Desloratadine ratiopharm been studied?
Danish: Hvordan blev Desloratadine ratiopharm undersøgt?
English: What is Desloratadine ratiopharm used for?
Danish: Hvad anvendes Desloratadine ratiopharm til?
English: How is Desloratadine ratiopharm used?
Danish: Hvordan anvendes Desloratadine ratiopharm?
English: How does Desloratadine ratiopharm work?
Danish: Hvordan virker Desloratadine ratiopharm?
English: (Invented) name Strength Pharmaceutical form
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Pakningsstørrelse
English: This summary was last updated in 12-2017.
Danish: Dette sammendrag blev sidst ajourført i 12-2017.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cubicin on 19 January 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cubicin den 19. januar 2006.
English: The full EPAR for Cubicin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Cubicin findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Cubicin.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cubicin.