natgillin/translations-raw huggingface dataset:
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Aubagio er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Aubagio’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Corbiltaer større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Corbilta’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Deltyba opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Deltyba’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Entyvio overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Entyvio’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Gazyvaro opvejer risiciene, og anbefalede, at det godkendes til anvendelse i Den Europæiske Union(EU).
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Gazyvaro’s benefits are greater than its risks and recommended that it be approved for use in the European Union (EU).
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Jardiance overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Jardiance’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Ketoconazole HRA overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Ketoconazole HRA’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Kyprolis er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Kyprolis’ benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Latuda overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Latuda’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Laventair overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Laventair’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Lojuxta er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Lojuxta’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Neuraceq opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Neuraceq’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Nexium Control er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Nexium Control’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Nuwiq overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Nuwiq’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Olysio overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Olysio’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Omidria er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Omidria are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Procysbi er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Procysbi’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Provenge er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Provenge’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Raxone er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Raxone are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Sirturo opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Sirturo’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Tafinlar opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Tafinlar’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Triumeq overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Triumeq’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Trulicity overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Trulicity’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Tybost er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Tybost’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Velphoro overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Velphoro’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Vimizim overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Vimizim’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Vitekta opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Vitekta’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Vizamyl overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Vizamyl’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Xigduo opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Xigduo’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) bemærkede, at Daklinza, anvendt i kombination med andre lægemidler, havde vist sig effektivt mod hepatitis C-virus, også hos patienter med virus af genotype 1, der var resistente mod tidligere behandling.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that Daklinza used in combination with other medicines was shown to be effective against hepatitis C virus, including in patients with genotype 1 resistant to previous treatment.
Agenturets udvalg for lægemidler til mennesker (CHMP) bemærkede, at Evarrest var påvist at være effektivt til at standse blødning ved operationer og kunne være et velegnet alternativ til andre produkter og teknikker.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that Evarrest was shown to be effective when used to stop bleeding in surgery and the product could be a suitable alternative to other products and techniques.
Agenturets udvalg for lægemidler til mennesker (CHMP) bemærkede, at hovedundersøgelsen havde vist, at MACI var overlegent over mikrofrakturoperation til behandling af bruskdefekter i knæet.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that the main study had shown that MACI was superior to microfracture surgery in treating patients with cartilage defects of the knee.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) bemærkede, at hovedundersøgelserne, hvoraf to stadig var i gang på vurderingstidspunktet, viste, at Zydelig virkede hos en stor andel af patienterne med kronisk lymfatisk leukæmi og follikulært lymfom.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that available data from the main studies, two of which were still ongoing at the time of the evaluation, showed high response rates with Zydelig in patients with chronic lymphocytic leukaemia and follicular lymphoma.
Agenturets udvalg for lægemidler til mennesker (CHMP) bemærkede, at Imlygic er et lægemiddel med en ny virkningsmekanisme, som kan være et værdifuldt supplement til eksisterende behandlinger for fremskredent inoperabelt melanom, som frembyder et uopfyldt medicinsk behov.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that Imlygic is a therapy with a novel mechanism of action which can be a valuable addition to existing therapies for advanced inoperable melanoma, an area of unmet medical need.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) bemærkede, at Imvanex er effektivt til at udløse produktion af antistoffer på et niveau, der forventes at yde beskyttelse mod kopper, selv om det nøjagtige niveau samt beskyttelsens varighed i forbindelse med et udbrud ikke er kendt.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that Imvanex is effective at triggering the production of antibodies to a level expected to provide protection against smallpox, although the exact level and duration of protection it would provide in an outbreak is not known.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) bemærkede, at stimulerende lægemidler er førstevalgsbehandling ved ADHD, og at disse lægemidler giver en større og mere ensartet bedring i symptomerne på ADHD som led i et omfattende behandlingsprogram.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that stimulant medicines are first line treatments for ADHD and that these medicines provide a larger and more consistent improvement in ADHD symptoms as part of a comprehensive treatment programme.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) bemærkede, at undersøgelserne havde vist, at Lonquex er effektivt til at reducere varigheden af svær neutropeni og antal tilfælde med febril neutropeni.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that the studies had shown that Lonquex is effective in reducing the duration of severe neutropenia and the number of febrile neutropenia cases.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) bemærkede, at Viekirax i kombination med andre lægemidler er effektivt til at eliminere hepatitis C-virus genotype 1a, 1b og 4, også hos patienter med skrumpelever.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that Viekirax in combination with other medicines is effective in clearing the hepatitis C virus genotypes 1a, 1b and 4, including in patients with liver scarring.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Abilify Maintena opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Abilify Maintena’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Cometriq opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Cometriq’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Erivedge opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Erivedge’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Imnovid opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Imnovid’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Incruse opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Incruse’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved NovoEight opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that NovoEight’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Odomzo opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Odomzo’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Relvar Ellipta opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Relvar Ellipta’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Somatropin Biopartners opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Somatropin Biopartners’ benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Stivarga opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Stivarga’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Tivicay opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Tivicay’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Ultibro Breezhaler opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Ultibro Breezhaler’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Ulunar Breezhaler opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Ulunar Breezhaler’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Xofigo opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Xofigo’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Xoterna Breezhaler opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Xoterna Breezhaler’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at Grastofil i overensstemmelse med EU-kravene er påvist at have en kvalitet, sikkerhed og virkning, der svarer til Neupogen.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Grastofil has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) er af den opfattelse, at fordelene ved Truberzi er beskedne, men at der er et udækket behov for at behandle irritabel tyktarm med diarré.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that the benefits of Truberzi are modest but there is an unmet need for treatments of irritable bowel syndrome with diarrhoea.
Agenturets udvalg for lægemidler til mennesker (CHMP) fandt, at anvendelsen af lutetium (177Lu) til radioaktiv mærkning af lægemidler var veletableret og veldokumenteret i den videnskabelige litteratur.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that the use of lutetium (177Lu) for radiolabelling medicines was well established and well documented in the scientific literature.
Agenturets udvalg for lægemidler til mennesker (CHMP) fandt, at de aktive indholdsstoffer er en velkendt kombination af lokalbedøvende midler, og at anvendelsen af en lokal spray giver mindst mulig optagelse af aktivt indholdsstof og dermed mindst mulig risiko for bivirkninger, der omfatter hele kroppen.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that the active ingredients are a well-known local anaesthetic combination, and the use of a local spray minimises the amount of active substance absorbed and hence the risk of side effects affecting the body as a whole.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) fremhævede, at Akynzeo var effektivt til at forhindre både de umiddelbare og forsinkede faser af kvalme og opkastning efter kemoterapi, og at lægemidlet har en gunstig sikkerhedsprofil.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that Akynzeo was effective at preventing both the immediate and delayed phases of nausea and vomiting following chemotherapy, and that the medicine has a favourable safety profile.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkludere, at fordelene ved Orbactiv opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Orbactiv’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkludere, at fordelene ved Xultophy opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Xultophy’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Alprolix opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore decided that Alprolix’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Cabometyx opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore decided that Cabometyx’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Elocta er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore concluded that its benefits are greater than its risks and recommended that it be approved in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Epclusa opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore decided that Epclusa’s benefits are greater than its risks and recommended that it be approved for use in the EU.