natgillin/translations-raw huggingface dataset:
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Episalvan 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 Episalvan’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 Idelvion 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 Idelvion’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 Kisplyx 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 Kisplyx’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 Lartruvo 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 Lartruvo’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 Oncaspar opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore concluded that the benefits of Oncaspar are greater than the risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Praxbind 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 Praxbind’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 Respreeza opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
Therefore, the Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Respreeza’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 Spectrila opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore concluded that the benefits of Spectrila are greater than the risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Wakix 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 Wakix’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 Zepatier 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 Zepatier’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, at anvendelsen af lutetium (177Lu) til radioaktiv mærkning af lægemidler var 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 documented in the scientific literature.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at Aripiprazole Accord i overensstemmelse med EU's krav er af sammenlignelig kvalitet og er bioækvivalent med Abilify.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Accord has been shown to have comparable quality and to be bioequivalent to Abilify.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at behandling med Holoclar var effektivt til at gendanne en sund hornhindeoverflade hos patienter med moderat til svær mangel på limbale stamceller efter forbrændinger, og at det gav bedring i deres symptomer og syn.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Holoclar treatment was effective in restoring healthy corneal surfaces in patients with moderate or severe limbal stem-cell deficiency caused by burns as well as in improving their symptoms and vision.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at Bemfola i henhold til EU- kravene til biosimilære lægemidler er påvist at være af en kvalitet, sikkerhed og virkningsprofil, der svarer til GONAL-f.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Bemfola has been shown to have a comparable quality, safety and effectiveness to GONAL-f.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at Cinacalcet Mylan i overensstemmelse med EU's krav er af sammenlignelig kvalitet og er bioækvivalent med Mimpara.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Cinacalcet Mylan has been shown to have comparable quality and to be bioequivalent to Mimpara.
Agenturets Udvalg for Lægemidler til mennesker (CHMP) konkluderede, at der ikke er nogen klinisk betydningsfuld forskel mellem Inhixa og Clexane, hvad angår virkning og sikkerhed, og at fordelene opvejer de identificerede risici som for Clexane.
Therefore, the Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that there are no clinically meaningful differences between Inhixa and Clexane in terms of effectiveness and safety and took the view that, as for Clexane, the benefit outweighs the identified risk.
Agenturets Udvalg for Lægemidler til mennesker (CHMP) konkluderede, at der ikke er nogen klinisk betydningsfuld forskel mellem Thorinane og Clexane, hvad angår virkning og sikkerhed, og at fordelene opvejer de identificerede risici som for Clexane.
Therefore, the Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that there are no clinically meaningful differences between Thorinane and Clexane in terms of effectiveness and safety and took the view that, as for Clexane, the benefit outweighs the identified risk.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det er påvist, at Flixabi og Remicades kvalitet, sikkerhed og virkning svarer til hinanden.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Flixabi has been shown to have a comparable quality, safety and effectiveness to Remicade.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Aripiprazole Sandoz er af sammenlignelig kvalitet og er bioækvivalent med Abilify.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Sandoz has been shown to have comparable quality and to be bioequivalent to Abilify.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Rasagilin Mylan er af sammenlignelig kvalitet og er bioækvivalent med Azilect.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Rasagiline Mylan has been shown to have comparable quality and to be bioequivalent to Azilect.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU’s krav er blevet påvist, at Marixino er af sammenlignelig kvalitet og er bioækvivalent med Ebixa.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Marixino has been shown to have comparable quality and to be bioequivalent to Ebixa.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU’s krav er blevet påvist, at Memantine LEK er af sammenlignelig kvalitet og er bioækvivalent med Axura.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine LEK has been shown to have comparable quality and to be bioequivalent to Axura.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU’s krav er blevet påvist, at Memantine Mylan er af sammenlignelig kvalitet og er bioækvivalent med Ebixa.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine Mylan has been shown to have comparable quality and to be bioequivalent to Ebixa.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU’s krav er blevet påvist, at Memantine ratiopharm er af sammenlignelig kvalitet og er bioækvivalent med Ebixa.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine ratiopharm has been shown to have comparable quality and to be bioequivalent to Ebixa.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU’s krav er blevet påvist, at Nemdatine er af sammenlignelig kvalitet og er bioækvivalent med Ebixa.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Nemdatine has been shown to have comparable quality and to be bioequivalent to Ebixa.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU’s krav er blevet påvist, at Voriconazole Accord er af sammenlignelig kvalitet og er bioækvivalent med Vfend.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Voriconazole Accord has been shown to have comparable quality and to be bioequivalent to Vfend.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU’s krav er påvist, at Zoledronsyre Accord er af sammenlignelig kvalitet og kan sammenlignes med Zometa.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zoledronic Acid Accord has been shown to have comparable quality and to be comparable to Zometa.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU’s krav til biosimilære lægemidler er påvist, at Abasaglars og Lantus’ kvalitet, sikkerhed og virkning svarer til hinanden.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Abasaglar has been shown to have a comparable quality, safety and effectiveness to Lantus.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU’s krav til biosimilære lægemidler er påvist, at Accofils og Neupogens kvalitet, sikkerhed og virkning svarer til hinanden.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Accofil has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU’s krav til biosimilære lægemidler er påvist, at Benepali og Enbrels kvalitet, sikkerhed og virkning svarer til hinanden.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Benepali has been shown to have a comparable quality, safety and effectiveness to Enbrel.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Blincyto opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Blincyto’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, at fordelene ved Bosulif er større end risiciene hos en gruppe patienter med et uopfyldt behandlingsbehov, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Bosulif’s benefits are greater than its risks in a sub-group of patients with an unmet medical need and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Brimica Genuair opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Brimica Genuair’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, at fordelene ved Briviact opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Briviact’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, at fordelene ved Cerdelga opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Cerdelga’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, at fordelene ved Cinqaero opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Cinqaero’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, at fordelene ved Clopidogrel/Acetylsalicylsyre Teva opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Clopidogrel/Acetylsalicylic acid Teva’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, at fordelene ved Coagadex opvejer 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 Coagadex are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Cosentyx overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Cosentyx’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, at fordelene ved Cotellic opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Cotellic’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, at fordelene ved Cresemba opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Cresemba’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, at fordelene ved Cyramza opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Cyramza’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, at fordelene ved Defitelio er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Defitelio’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, at fordelene ved Descovy opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Descovy’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, at fordelene ved Duaklir Genuair opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Duaklir Genuair’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, at fordelene ved Duavive opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Duavive’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, at fordelene ved Duloxetin Lilly opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Duloxetine Lilly’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, at fordelene ved Dutrebis opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Dutrebis’ 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, at fordelene ved Ebymect opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Ebymect’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, at fordelene ved Ecalta opvejer risiciene ved behandling af invasiv candidiasis hos voksne patienter.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Ecalta’s benefits are greater than its risks for the treatment of invasive candidiasis in adult patients.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Edistride opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Edistride’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, at fordelene ved Empliciti opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Empliciti’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, at fordelene ved Entresto opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Entresto’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, at fordelene ved Enzepi opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Enzepi’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, at fordelene ved Eperzan er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Eperzan’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, at fordelene ved Evotaz opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Evotaz’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, at fordelene ved Feraccru opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Feraccru’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, at fordelene ved Fexeric opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Fexeric’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, at fordelene ved Fluenz Tetra opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Fluenz Tetra’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, at fordelene ved Galafold opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Galafold’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, at fordelene ved Gardasil 9 opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Gardasil 9’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, at fordelene ved Genvoya opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Genvoya’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, at fordelene ved Giotrif opvejer 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 Giotrif outweigh its risks and recommended that it be granted marketing authorisation in the EU.