FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of flea infestation in dogs (Ctenocephalides felis and C. canis) for at least 5 weeks.
Danish: Behandling af loppeinfestation hos hund (Ctenocephalides felis og C.Canis) i mindst 5 uger.
English: Afoxolaner in the dog is metabolised to more hydrophilic compounds and then eliminated.
Danish: Hos hund metaboliseres afoxolaner til mere hydrofile forbindelser før det elimineres.
English: The product kills fleas before egg production and therefore prevents household contamination.
Danish: Præparatet dræber lopper før ægproduktion og forebygger derfor smittespredning til omgivelserne.
English: Macrogol 15 hydroxystearate Glycerol (E422) Medium-chain triglycerides
Danish: Macrogol 15 hydroxystearat Glycerol (E422)
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: To prevent children from getting access to the veterinary medicinal product, remove only one chewable tablet at a time from the blister.
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: For at forhindre at børn får adgang til veterinærlægemidlet, skal der kun tages én tablet ud af blisteret ad gangen.
English: Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Danish: Indehaver af markedsføringstilladelsen: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein TYSKLAND
English: EU/2/19/240/015 EU/2/19/240/016
Danish: EU/2/19/240/012 EU/2/19/240/013 EU/2/19/240/014 EU/2/19/240/015 EU/2/19/240/016
English: The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Danish: Præparatet kan indgå som led i behandlingen af loppebetinget allergisk dermatitis (FAD).
English: Treatment schedule:
Danish: Behandlingsinterval:
English: Each chewable tablet contains: Afoxolaner MERIAL
Danish: En tyggetablet indeholder: Afoxolaner MERIAL
English: One carton contains one blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet.
Danish: 1 æske indeholdende ét blister à 1, 3 eller 6 tyggetabletter eller 15 blistre à 1 tyggetablet.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals To prevent children from getting access to the veterinary medicinal product, remove only one chewable tablet at a time from the blister.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr For at forhindre at børn får adgang til veterinærlægemidlet, skal der kun tages én tablet ud af blisteret ad gangen.
English: The metabolites and parent compound are eliminated from the body via urinary and biliary excretion with the majority eliminated in the bile.
Danish: Metabolitter og modersubstans elimineres fra kroppen via urin og galde, heraf hovedparten via galden.
English: Pregnancy and lactation:
Danish: Drægtighed og diegivning:
English: Soy protein fines Braised beef flavouring Povidone (E1201) Macrogol 400
Danish: Povidon (E1201) Macrogol 400
English: Treatment of flea and tick infestations:
Danish: Behandling af loppe- og flåtinfestation:
English: Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis).
Danish: Behandling af skab (forårsaget af Sarcoptes scabiei var. canis)
English: Treatment of tick infestation in dogs (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus).
Danish: Behandling af flåtangreb hos hund (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus).
English: Dogs 2-4 kg Dogs >4-10 kg Dogs >10-25 kg Dogs >25-50 kg
Danish: Hund 2-4 kg Hund >4-10 kg Hund >10-25 kg Hund >25-50 kg
English: Treatment of demodicosis (caused by Demodex canis).
Danish: Behandling af demodecose (forårsaget af Demodex canis).
English: Treatment of demodicosis (caused by Demodex canis):
Danish: Behandling af demodecose (forårsaget af Demodex canis):
English: Mild gastrointestinal effects (vomiting, diarrhoea), pruritus, lethargy, anorexia, and neurological signs (convulsions, ataxia and muscle tremors) have been reported very rarely.
Danish: I meget sjældne tilfælde er der rapporteret om lette gastrointestinale forstyrrelser (opkastning, diarré), pruritus, letargi, anoreksi og neurologiske symptomer (kramper, ataksi og muskelrysten).
English: Afoxolaner MERIAL is active against adult fleas as well as several tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum, and Haemaphysalis longicornis.
Danish: Afoxolaner MERIAL virker over for voksne lopper samt over for flere flåtarter så som Dermacentor reticulatus og D. variabilis, Ixodes ricinus og I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum, og Haemaphysalis longicornis.
English: Afoxolaner is active against adult fleas as well as several tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum and Haemaphysalis longicornis.
Danish: Afoxolaner virker over for voksne lopper samt over for flere flåtarter så som Dermacentor reticulatus og D. variabilis, Ixodes ricinus og I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum, og Haemaphysalis longicornis.
English: Mottled red to reddish brown, circular shaped (tablets for dogs 2-4 kg), or rectangular shaped (tablets for dogs >4-10 kg, tablets for dogs >10-25 kg and tablets for dogs >25-50 kg).
Danish: Marmoreret rød til rødbrun, rund (tablet til hund 2-4 kg) eller rektangulær (tablet til hund >4-10 kg, tablet til hund >10-25 kg og tablet til hund >25-50 kg).
English: 31000 Toulouse
Danish: 4 Chemin du Calquet 31000 Toulouse
English: Maize starch
Danish: Majsstivelse
English: chewable tablets for dogs 2-4 kg chewable tablets for dogs >4-10 kg chewable tablets for dogs >10-25 kg chewable tablets for dogs >25-50 kg
Danish: Tyggetabletter til hund 2-4 kg Tyggetabletter til hund >4-10 kg Tyggetabletter til hund >10-25 kg Tyggetabletter til hund >25-50 kg Alle hjælpestoffer er anført under pkt.
English: • rare (more than 1 but less than 10 animals in 10,000 animals treated)
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelige (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr ud af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)>
English: Chewable tablets
Danish: Soyaprotein
English: Afoxolaner MERIAL 11 mg dogs 2-4 kg Afoxolaner MERIAL 28 mg dogs >4-10 kg Afoxolaner MERIAL 68 mg dogs >10-25 kg Afoxolaner MERIAL 136 mg dogs >25-50 kg afoxolaner
Danish: Afoxolaner MERIAL 11 mg hund 2-4 kg Afoxolaner MERIAL 28 mg hund >4-10 kg Afoxolaner MERIAL 68 mg hund >10-25 kg Afoxolaner MERIAL 136 mg hund >25-50 kg afoxolaner.
English: Chewable tablets.
Danish: Tyggetablet.
English: PACKAGE LEAFLET: Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs >4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs >10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs >25-50 kg
Danish: INDLÆGSSEDDEL: Afoxolaner MERIAL 11 mg tyggetabletter til hund 2-4 kg Afoxolaner MERIAL 28 mg tyggetabletter til hund >4-10 kg Afoxolaner MERIAL 68 mg tyggetabletter til hund >10-25 kg Afoxolaner MERIAL 136 mg tyggetabletter til hund >25-50 kg
English: Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs >4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs >10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs >25-50 kg afoxolaner
Danish: Afoxolaner MERIAL 11 mg tyggetabletter til hund 2-4 kg Afoxolaner MERIAL 28 mg tyggetabletter til hund >4-10 kg Afoxolaner MERIAL 68 mg tyggetabletter til hund >10-25 kg Afoxolaner MERIAL 136 mg tyggetabletter til hund >25-50 kg afoxolaner
English: Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs >4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs >10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs >25-50 kg
Danish: Afoxolaner MERIAL 11 mg tyggetabletter til hund 2-4 kg Afoxolaner MERIAL 28 mg tyggetabletter til hund >4-10 kg Afoxolaner MERIAL 68 mg tyggetabletter til hund >10-25 kg Afoxolaner MERIAL 136 mg tyggetabletter til hund >25-50 kg
English: EMEA/H/C/product number
Danish: EMA/H/C/produkt nr.
English: The company that applied for authorisation is Celgene Europe Ltd.
Danish: Den virksomhed, der har indgivet ansøgningen, er Celgene Europe Ltd.
English: What is Istodax?
Danish: Hvad er Istodax?
English: Therefore it was not possible to conclude that the benefits of the medicine outweigh the risks and the CHMP confirmed its initial negative opinion.
Danish: Det kunne derfor ikke konkluderes, at lægemidlets fordele overstiger risiciene, og CHMP bekræftede sin indledende negative udtalelse.
English: EMA/725439/2012
Danish: Den 15. november 2012 EMA/725439/2012
English: In particular, the Committee could not conclude on the clinical benefit of the medicine.
Danish: Navnlig kunne udvalget ikke drage konklusioner om lægemidlets kliniske fordel.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse eller i et program for anvendelse med særlig udleveringstilladelse og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
English: The effects of Istodax were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Istodax blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Istodax is a medicine that contains the active substance romidepsin.
Danish: Istodax er et lægemiddel, der indeholder det aktive stof romidepsin.
English: The main measure of effectiveness was based on the proportion of patients who had a complete response to treatment.
Danish: Behandlingens virkning blev hovedsagelig målt på den andel af patienterne, der udviste fuldstændig respons på behandlingen.
English: In the study, Istodax was not compared with any other treatment.
Danish: I undersøgelsen blev Istodax ikke sammenlignet med nogen anden behandling.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Istodax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Istodax findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Refusal of the marketing authorisation for Istodax (romidepsin) EMA/725439/2012
Danish: Afslag på ansøgningen om markedsføringstilladelse for Istodax (romidepsin) EMA/725439/2012
English: As it was not compared with any other treatment, it was not possible to establish whether the observed effects were due to the medicine or due to the disease characteristics of patients in the main study.
Danish: Da lægemidlet ikke var sammenlignet med nogen anden behandling, kunne det ikke fastslås, om de iagttagne virkninger skyldtes lægemidlet eller sygdommens egenskaber hos patienterne i hovedundersøgelsen.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 15 November 2012.
Danish: Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en fornyet overvejelse af den første udtalelse og fastholdt den 15. november 2012 afslaget på ansøgningen om markedsføringstilladelse.
English: What was Istodax expected to be used for?
Danish: Hvad forventedes Istodax anvendt til?
English: The CHMP also noted that, due to an oversight, the company failed to provide an adequate certificate of Good Manufacturing Practice for the site where the medicine is manufactured, which is legally required.
Danish: CHMP konstaterede desuden, at virksomheden ved en fejl havde undladt at fremlægge et tilfredsstillende certifikat for god fremstillingspraksis for fremstillingsstedet for lægemidlet, hvilket kræves ifølge loven.
English: However, the fact that Istodax was not compared with any other treatment did not allow the Committee to conclude on the clinical benefit of the medicine in terms of overall survival (how long the patients lived) or progression-free survival (how long the patients lived without their disease getting worse).
Danish: Da Istodax ikke blev sammenlignet med nogen anden behandling, kunne udvalget imidlertid ikke drage konklusioner om lægemidlets kliniske fordel i form af samlet overlevelse (hvor længe patienterne levede) eller progressionsfri overlevelse (hvor længe patienterne levede uden forværring af sygdommen).
English: Refusal of the marketing authorisation for Istodax (romidepsin)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Istodax (romidepsin)
English: Peripheral T-cell lymphoma is a cancer of a type of white blood cells called T-cells, which are part of the immune system.
Danish: Perifert T-cellelymfom er kræft, der udgår fra hvide blodlegemer af typen T-celler, som er en del af immunsystemet.
English: In November 2012, following the re-examination, the CHMP removed its concern over the certificate of Good Manufacturing Practice, but retained its other concerns.
Danish: Efter den fornyede overvejelse i november 2012 bortfaldt CHMP's betænkeligheder vedrørende certifikatet for god fremstillingspraksis, men de øvrige betænkeligheder bestod.
English: On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Istodax, intended for the treatment of peripheral T-cell lymphoma.
Danish: Den 19. juli 2012 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Istodax, som er bestemt til behandling af perifert T-cellelymfom.
English: The company presented the results from one main study with Istodax involving 131 patients with peripheral T-cell lymphoma who had received previous treatment.
Danish: Virksomheden fremlagde resultaterne af én hovedundersøgelse med Istodax, hvori der deltog 131 patienter med perifert T-cellelymfom, som tidligere var blevet behandlet.
English: How is Istodax expected to work?
Danish: Hvordan forventes Istodax at virke?
English: In July 2012, the CHMP noted that the main study showed that Istodax had anti-tumour activity in terms of patients' response to treatment.
Danish: I juli 2012 konstaterede CHMP, at hovedundersøgelsen viste, at Istodax havde virkning på sygdommen, målt som patienternes respons på behandlingen.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Istodax.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der aktuelt deltager i kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Istodax.
English: Istodax was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 October 2005 for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated).
Danish: Den 28. oktober 2005 blev Istodax udpeget som “lægemiddel til sjældne sygdomme” til behandling af perifert T-cellelymfom (nodalt, andet ekstranodalt og leukæmisk/dissemineret).
English: Istodax was expected to be used for the treatment of adults with peripheral T-cell lymphoma that no longer responds to or has come back after at least two previous therapies.
Danish: Istodax forventedes anvendt til behandling af voksne med perifert T-cellelymfom ved manglende behandlingsvirkning eller tilbagefald af sygdommen efter mindst to forudgående behandlinger.
English: The exact way that romidepsin works in peripheral T-cell lymphoma is not known, but its effects on genes that regulate cell proliferation and cell death are expected to lead to a reduction in the rate of growth and division of the cancer cells.
Danish: Det vides ikke nøjagtigt, hvordan romidepsin virker ved perifert T-cellelymfom, men romidepsin forventes at bremse kræftcellernes vækst og deling ved sin indvirkning på de gener, der regulerer cellernes formering og død.
English: The active substance in Istodax, romidepsin, is expected to work by blocking the activity of proteins called histone deacetylases, which are involved in turning genes ‘on' and ‘off' within cells.
Danish: Det aktive stof i Istodax, romidepsin, virker ved at blokere enzymer af typen histonedeacetylaser, som slår generne “fra” eller “til” i cellerne.
English: It was to be available as a powder and solvent to be made into a solution for infusion (drip into a vein).
Danish: Det leveres som et pulver, der efter opløsning i den medfølgende væske indgives ved infusion (med drop i en vene).
English: In both studies there were no cases of resistance to treatment after 48 weeks.
Danish: I begge studier var der ingen tilfælde af resistens over for behandling efter 48 uger.
English: As for all medicines, data on the use of Dovato are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Dovato løbende overvåget.
English: Other information about Dovato
Danish: Andre oplysninger om Dovato
English: Both active substances have already been authorised in the European Union as separate tablets: dolutegravir in 2014 and lamivudine in 1996.
Danish: Begge aktive stoffer er allerede godkendt i Den Europæiske Union som separate tabletter:dolutegravir i 2014 og lamivudin i 1996.
English: The patient should take one tablet once a day.
Danish: Den anbefalede dosis er én tablet én gang dagligt.
English: Dovato is a medicine for treating infection with human immunodeficiency virus type 1 (HIV-1) in adults and adolescents over 12 years old who weigh at least 40 kg.
Danish: Dovato er et lægemiddel til behandling af infektion med humant immundefektvirus type 1 (hiv-1) hos voksne og unge over 12 år, der vejer mindst 40 kg.
English: What measures are being taken to ensure the safe and effective use of Dovato?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Dovato?
English: For more information about using Dovato, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Dovato, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Dovato (dolutegravir / lamivudine)
Danish: Dovato (dolutegravir / lamivudin)
English: An overview of Dovato and why it is authorised in the EU
Danish: En oversigt over Dovato, og hvorfor det er godkendt i EU
English: Side effects reported with Dovato are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Dovato vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Dovato is available as tablets containing 50 mg of dolutegravir and 300 mg of lamivudine.
Danish: Dovato fås som tabletter, der indeholder 50 mg dolutegravir og 300 mg lamivudin.
English: Triple combination therapy is used for HIV treatment to reduce the chance of the virus becoming resistant to treatment.
Danish: Tredobbelt kombinationsbehandling anvendes til hiv-behandling for at mindske risikoen for, at virussen bliver resistent over for behandling.
English: Why is Dovato authorised in the EU?
Danish: Hvorfor er Dovato godkendt i EU?
English: The most common serious side effects (which may affect up to 1 in 100 people) are allergic reactions, including rash and severe liver problems.
Danish: De hyppigste alvorlige bivirkninger (som kan forekomme hos op til 1 ud af 100 personer) er allergiske reaktioner, herunder udslæt og alvorlige leverproblemer.
English: Dovato does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Dovato helbreder ikke hivinfektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: In these studies, 91% of patients with HIV-1 who took the Dovato combination no longer had detectable levels of HIV (below 50 copies per ml) after 48 week compared with 93% of those who were taking the triple combination.
Danish: I disse studier var der hos 91 % af de patienter med hiv-1, som fik Dovato-kombinationen, ikke længere målelige koncentrationer af hiv (under 50 kopier pr. ml) efter 48 uge sammenlignet med 93 % af dem, der tog den tredobbelte kombination.
English: What is Dovato and what is it used for?
Danish: Hvad er Dovato, og hvad anvendes det til?
English: Dovato (dolutegravir / lamivudine) EMA/276259/2019
Danish: Dovato (dolutegravir / lamivudin) EMA/276259/2019
English: What are the risks associated with Dovato?
Danish: Hvilke risici er der forbundet med Dovato?
English: The most common side effects with Dovato (which may affect up to 1 in 10 people) are headache, diarrhoea, nausea and difficulty sleeping.
Danish: De hyppigste bivirkninger ved Dovato (som kan forekomme hos op til 1 ud af 10 personer) er hovedpine, diarré, kvalme og søvnbesvær.
English: Dovato can only be obtained with a prescription and should be prescribed by a doctor who is experienced in managing HIV infection.
Danish: Dovato fås kun på recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hivinfektion.
English: The two active substances in Dovato, dolutegravir and lamivudine, block the activity of enzymes that the virus uses to make new copies of itself.
Danish: De to aktive stoffer i Dovato, dolutegravir og lamivudin, blokerer de enzymer, som virussen bruger til at fremstille nye eksemplarer af sig selv.
English: In two main studies, the Dovato combination was just as effective as a triple combination in patients with HIV-1, with no cases of resistance developing in these patients.
Danish: I to hovedstudier var Dovato-kombinationen lige så effektiv som en tredobbelt kombination hos patienter med hiv-1, og der var ingen tegn på udvikling af resistens hos disse patienter.
English: Dolutegravir stops the activity of an enzyme called integrase (and is known as an integrase inhibitor), while lamivudine stops the activity of reverse transcriptase (and is known as a nucleoside reverse transcriptase inhibitor or NRTI).
Danish: Dolutegravir blokerer et enzym kaldet integrase (og kaldes en integrasehæmmer), mens lamivudin forhindrer revers transkriptase (og kaldes en nukleotid revers transkriptase-hæmmer eller NRTI).
English: This medicine contains the active substances dolutegravir and lamivudine and is used to treat infections that are not resistant to medicines of the same class as dolutegravir or to lamivudine.
Danish: Dette lægemiddel indeholder de aktive stoffer dolutegravir og lamivudin og anvendes til behandling af infektioner, der ikke er resistente over for lægemidler i samme klasse som dolutegravir eller lamivudin.
English: Two main studies, involving 1,441 patients, have shown that the combination of the two active substances in Dovato is as effective at lowering the amount of HIV in the blood as a triple combination therapy (dolutegravir plus tenofovir plus emtricitabine).
Danish: To hovedstudier, hvori der indgik 1.433 patienter, har vist, at kombinationen af de to aktive stoffer i Dovato er lige så effektiv til at reducere mængden af hiv i blodet som en tredobbelt kombinationsbehandling (dolutegravir, tenofovir og emtricitabin).
English: Dovato received a marketing authorisation valid throughout the EU on 1 July 2019 Further information on Dovato can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dovato This overview was last updated in 08-2019.
Danish: Yderligere information om Dovato findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/dovato