FrancophonIA/ELRC3.0 huggingface dataset:
English: Although spontaneous reporting suggested that the safety signal concerning the overdose was not significant, other more complete data, particularly from forensic centres and national mortality statistics confirmed that the risk of accidental fatal overdose under normal conditions of use associated with dextropropoxyphene containing products is of major concern, mainly due to their narrow therapeutic index and high case fatality.
Danish: Selv om spontane rapporter antydede, at sikkerhedsrisikoen i forbindelse med overdosering ikke var signifikant, bekræftede andre mere udførlige data, især fra retsmedicinske centre og nationale dødsstatistikker, at risikoen for en utilsigtet dødelig overdosering under normale anvendelsesbetingelser, der kan sammenkædes med lægemidler indeholdende dextropropoxyfen, er et stort problem, hovedsageligt på grund af deres snævre terapeutiske indeks og høje dødsrate.
English: Therefore, the CHMP concluded by majority that the benefit-risk balance of dextropropoxyphene containing medicinal products is negative and that its Opinion of 25 June 2009 should not be revised for oral/rectal dextropropoxyphene containing medicinal products and recommended the withdrawal of the Marketing Authorisations to be effective within the next 15 months of the Commission Decision in order to allow switching patients to safer alternatives, considering the extensive clinical use of dextropropoxyphene containing medicinal products and the wide patient exposure in some Member States.
Danish: CHMP konkluderede derfor, at benefit/risk-forholdet for lægemidler indeholdende dextropropoxyfen er negativt, og at dets udtalelse af 25. juni 2009 ikke skulle revideres for orale/rektale lægemidler indeholdende dextropropoxyfen, og anbefalede en tilbagekaldelse af markedsføringstilladelserne, som skal gælde i en periode på 15 måneder fra Kommissionens beslutning for at gøre det muligt for patienter at skifte til sikrere alternativer, navnlig i betragtning af den udbredte kliniske anvendelse af lægemidler indeholdende dextropropoxyfen og den store patienteksponering i visse medlemsstater.
English: Having considered the detailed grounds for re-examination provided by the group of MAHs in writing and in an oral explanation, the CHMP considered that the design of the proposed clinical study to demonstrate the superior efficacy for combination of dextropropoxyphene and paracetamol versus paracetamol alone was flawed, and even a well-designed study would not change the benefit-risk balance of the dextropropoxyphene medicinal products in view of the narrow therapeutic index.
Danish: Efter en gennemgang af den detaljerede skriftlige begrundelse for revurdering og den mundtlige redegørelse fra gruppen af indehavere af markedsføringstilladelse fandt CHMP, at udformningen af den foreslåede kliniske undersøgelse til påvisning af, at kombinationen af dextropropoxyfen og paracetamol havde bedre virkning end paracetamol alene, var fejlbehæftet, og at selv en veldesignet undersøgelse ikke ville ændre benefit/risk-forholdet for lægemidler indeholdende dextropropoxyfen i lyset af det snævre terapeutiske indeks.
English: While some patients find these products helpful in managing pain, results from clinical trials do not provide evidence for the superior efficacy of dextropropoxyphene alone or in combination with paracetamol, when compared with normal therapeutic doses of simple analgesics.
Danish: Nogle patienter oplever, at disse lægemidler er effektive til smertebehandling, men resultater fra kliniske undersøgelser giver ikke dokumentation for højere effekt af dextropropoxyfen alene eller i kombination med paracetamol sammenlignet med normale terapeutiske doser af simple smertestillende lægemidler.
English: After reviewing all the available data, the CHMP considered that the different figures provided by the data sources (spontaneous reports, forensic and poison centres, national mortality statistics) showed overall a significant number of deaths in which dextropropoxyphene is present at toxic levels.
Danish: Efter at have gennemgået alle tilgængelige data vurderede CHMP, at de forskellige tal, der fremgår af datakilderne (spontane rapporter, retsmedicinske centre, giftinformationscentraler, nationale dødsstatistikker), generelt viste et betydeligt antal af dødsfald, hvor dextropropoxyfen fandtes på toksisk niveau.
English: Member State Marketing Authorisation Holder Product Name
Danish: Medlemsstat Indehaver af markedsføringstilladelse
English: The different figures provided by the available data sources (spontaneous reports, forensic and poison centres, national mortality statistics) showed overall a significant number of deaths in which dextropropoxyphene is present at toxic levels.
Danish: De forskellige tal, der fremgår af datakilderne (spontane rapporter, retsmedicinske centre, giftinformationscentraler, nationale dødsstatistikker), viste generelt et betydeligt antal dødsfald, hvor dextropropoxyfen fandtes på toksisk niveau.
English: - The Committee considered that dextropropoxyphene containing medicinal products showed only limited efficacy in the symptomatic treatment of pain;
Danish: - Udvalget vurderede, at lægemidler indeholdende dextropropoxyfen kun havde begrænset effekt ved symptomatisk behandling af smerter.
English: Available data showed only limited efficacy of the dextropropoxyphene medicinal products in the symptomatic treatment of pain.
Danish: De tilgængelige data viste kun en begrænset effekt af lægemidler indeholdende dextropropoxyfen til symptomatisk behandling af smerter.
English: Modified release capsule Oral use
Danish: Kapsel med modificeret udløsning
English: The CHMP also considered that data collected from national poison centres have limitations in this situation as dextropropoxyphene can cause death extremely rapidly (in under an hour); if a patient dies before reaching medical attention, the poisons centre is unlikely to be contacted.
Danish: CHMP mente desuden, at de data, der er indsamlet fra de nationale giftinformationscentraler, også har begrænsninger i denne situation, da dextropropoxyfen kan være dødbringende efter ekstremt kort tid (under en time).
English: Similarly, proposals to limit supplies for each prescription to at most 15 days, or one month, before review is needed by the prescriber, are unlikely to be of any significant benefit in risk minimisation: the patient will still have access to significant large quantity in excess of the lethal dose.
Danish: Forslag om at begrænse hver enkelt recept til højst 15 dage eller en måned, før den, der har udskrevet recepten, skal revidere den, vil sandsynligvis ikke få nogen betydning for risikominimeringen.
English: 117 Allée des Parcs 69800 Saint Priest France
Danish: Qualimed 117 Allée des Parcs 69800 Saint Priest France
English: However no consideration was given to the need for national mortality data, and in particular forensic pathology data, to ensure that any risk minimisation measures are working: it is not possible to use routinely-collected (spontaneous) data to assess the effectiveness of the risk minimisation measures, because of the significant under-reporting of even serious adverse events, including death.
Danish: Det er ikke muligt at anvende rutinemæssigt indsamlede (spontane) data til at vurdere effektiviteten af foranstaltninger til risikominimering på grund af den betydelige underrapportering af endog alvorlige bivirkninger, herunder dødsfald.
English: However, there is no clear evidence from clinical trials of superiority of efficacy of the combination of dextropropoxyphene and paracetamol compared with normal therapeutic doses of paracetamol alone, the trials which have suggested superiority to paracetamol alone have used sub-therapeutic doses of paracetamol.
Danish: Der foreligger dog ikke tilstrækkelig dokumentation fra kliniske forsøg for, at effekten af kombinationen af dextropropoxyfen og paracetamol skulle være højere end ved normale terapeutiske doser af paracetamol.
English: In acute pain, the fixed combination of dextropropoxyphene and paracetamol appeared to be an effective analgesic; this is to be expected, as paracetamol alone is an effective analgesic.
Danish: Til akutte smerter var den faste kombination af dextropropoxyfen og paracetamol tilsyneladende et effektivt smertestillende lægemiddel.
English: Rua Consiglieri Pedroso 123 Queluz de Baixo Apartado 1001 2731 901 Barcarena Portugal
Danish: 2731 901 Barcarena Portugal
English: Dextropropoxyphene Paracetamol almus
Danish: Dextropropoxyphene Paracetamol Theraplix
English: Eg Labo - Laboratoires EUROGENERICS "Le Quintet" - bâtiment A 92517 Boulogne Billancourt Cedex France
Danish: Eg Labo - Laboratoires EUROGENERICS "Le Quintet" - bâtiment A
English: Dextropropoxyphene Paracetamol Zydus
Danish: Dextropropoxyphene Paracetamol biogaran
English: Dextropropoxyphene Paracetamol biogaran 30 mg/400 mg
Danish: Dextropropoxyphene Paracetamol Zydus 30 mg/400 mg
English: Dextropropoxyphene Paracetamol qualimed 30 mg/400 mg
Danish: Dextropropoxyphene Paracetamol Teva 30 mg/400 mg
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, indgivelsesveje, ansøgere, indehavere af markedsføringstilladelser i medlemsstaterne
English: United Kingdom Manx Healthcare Limited Taylor Group House
Danish: Storbritannien Manx Healthcare Limited Taylor Group House
English: United Kingdom Wockhardt UK Limited Ash Road North
Danish: Storbritannien Wockhardt UK Limited Ash Road North
English: United Kingdom Bristol Laboratories Limited Unit 3, Canalside
Danish: Storbritannien Bristol Laboratories Limited Unit 3, Canalside
English: United Kingdom Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar,
Danish: Storbritannien Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar,
English: United Kingdom Athlone Pharmaceuticals Limited, Ballymurray, Roscommon, Co.
Danish: Storbritannien Athlone Pharmaceuticals Limited, Ballymurray, Roscommon, Co.
English: JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA
Danish: Grækenland JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA
English: Belgium Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Danish: Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium
English: United Kingdom Focus Pharmaceuticals Limited Unit 5, Faraday Court
Danish: Storbritannien Focus Pharmaceuticals Limited Unit 5, Faraday Court
English: mg/100 ml syrup
Danish: mg/100 ml sirup
English: United Kingdom Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire
Danish: Storbritannien Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire
English: United Kingdom McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
Danish: Storbritannien McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
English: PIERRE FABRE MEDICINES SA Messogeion 350, Agia Paraskevi
Danish: Grækenland PIERRE FABRE MEDICINES SA Messogeion 350, Agia Paraskevi
English: 5 mg oral suspension oral use
Danish: 5 mg oral suspension Oral anvendelse
English: United Kingdom Medreich plc, Warwick House, Plane Tree Crescent, Feltham TW13 7HF United Kingdom domperidone maleate
Danish: Storbritannien Medreich plc, Warwick House, Plane Tree Crescent, Feltham TW13 7HF United Kingdom domperidone maleate
English: UAB „Johnson & Johnson“ Geležinio Vilko g. 18A LT-08104 Vilnius Lithuania domperidone Motilium 10 mg filmcoated tablets
Danish: UAB „Johnson & Johnson“ Geležinio Vilko g. 18A LT-08104 Vilnius Lithuania domperidone Motilium 10 mg filmovertrukket tablets
English: United Kingdom Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stokeon-Trent, Staffordshire ST3 7UN United Kingdom domperidone maleate
Danish: Storbritannien Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stokeon-Trent, Staffordshire ST3 7UN United Kingdom domperidone maleate
English: United Kingdom Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD, United Kingdom domperidone maleate
Danish: Storbritannien Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD, United Kingdom domperidone maleate
English: Str. Fabricii nr. 124, Cluj Napoca, Romania
Danish: Rumænien S.C. TERAPIA S.A. Str. Fabricii nr. 124, Cluj Napoca, Romania
English: Belgium Apotex NV Av Etienne Demunter 5/8 1090 Brussels
Danish: Av Etienne Demunter 5/8 1090 Brussels Belgium
English: 1 mg/ml oral suspension oral use
Danish: 1 mg/ml oral suspension Oral anvendelse
English: Belgium domperidone Motilium pediatrie 1 mg/ml oral suspension oral use
Danish: Belgium domperidone Motilium pediatrie 1 mg/ml oral suspension Oral anvendelse
English: Epidarvou 4 & Aigialeias Maroussi 15125
Danish: Maroussi 15125
English: Domperidone Motilium Tropfen 10 mg oral drops, suspension
Danish: Domperidone Motilium Tropfen 10 mg oral drabber, suspension
English: United Kingdom Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom domperidone Domperidone 1mg/ml Oral
Danish: Storbritannien Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom domperidone Domperidone 1mg/ml Oral
English: United Kingdom Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom domperidone maleate
Danish: Storbritannien Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom domperidone maleate
English: Johnson & Johnson Consumer B.V. Rooseveltweg 15
Danish: Johnson & Johnson Consumer B.V.
English: Ranbaxy Pharmacie Génériques 11-15 Quai Dion Bouton 92800 Puteaux domperidone DOMPERIDONE RPG 10 mg, comprimé pelliculé
Danish: Ranbaxy Pharmacie Génériques 11-15 Quai Dion Bouton 92800 Puteaux
English: 10 mg dispersible tablet
Danish: 10 mg opløselig tablet
English: 10 mg orodispersible tablet oral use
Danish: 10 mg oroopløselig tablet Oral anvendelse
English: Portugal domperidone Domperidona Mylan 10 mg film-coated tablet
Danish: Portugal domperidone Domperidona Mylan 10 mg filmovertrukket tablet
English: 20 mg effervescent granules
Danish: 20 mg brusegranulat
English: 5 mg effervescent granules
Danish: 5 mg brusegranulat
English: Motilium 10mg Filmcoated Tablets
Danish: Motilium 10mg Filmovertrukket Tablets
English: Luxembourg Johnson & Johnson Consumer N.V. Antwerpseweg 15-17
Danish: Luxembourg Johnson & Johnson Consumer N.V.
English: 10 mg effervescent granules
Danish: 10 mg brusegranulat
English: Belgium domperidone Motilium-60 supp 60 mg suppository rectal use
Danish: Belgium domperidone Motilium-60 supp 60 mg stikpille
English: Belgium domperidone Motilium-30 supp 30 mg suppository rectal use
Danish: Belgium domperidone Motilium-30 supp 30 mg stikpille
English: Domperidone mylan 10 mg film-coated tablet
Danish: Domperidone mylan 10 mg filmovertrukket tablet
English: DOMPERIDONE MOTILIUM 10 mg 10 mg film-coated tablet
Danish: DOMPERIDONE MOTILIUM 10 mg 10 mg filmovertrukket tablet
English: Belgium domperidone Motilium Instant-10 10 mg orodispersible tablet oral use
Danish: Belgium domperidone Motilium Instant-10 10 mg smeltetablet
English: 75116 Paris domperidone DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable
Danish: France domperidone DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable
English: 30 mg suppository rectal use
Danish: 30 mg suppositorie
English: 92787 Issy-les-Moulineaux Cedex domperidone MOTILIUM 10 mg, granulés effervescents en sachet-dose
Danish: France domperidone MOTILIUM 10 mg, granulés effervescents en sachet-dose
English: 75116 Paris domperidone DOMPERIDONE SGPHARM 20 mg, comprimé pelliculé sécable.
Danish: France domperidone DOMPERIDONE SGPHARM 20 mg, comprimé pelliculé sécable.
English: Belgium domperidone Domperidone EG-10 10 mg orodispersible tablet oral use
Danish: Belgium domperidone Domperidone EG-10 10 mg smeltetablet
English: 75116 Paris domperidone DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.
Danish: France domperidone DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.
English: Belgium Pierre Fabre Médicament 45 place Abel Gance
Danish: Rumænien Pierre Fabre Médicament 45 place Abel Gance
English: B-2340, Beerse Belgium domperidone MOTILIUM SUPPOSITORY 30MG
Danish: B-2340, Beerse Belgium domperidone MOTILIUM STIKPILLE 30MG
English: Belgium Eurogenerics N.V. Heizel Esplanade b22
Danish: Heizel Esplanade b22 1020 Brussels Belgium
English: Domperidone Motilium Rx 10 mg Film-coated Tablets.
Danish: Domperidone Motilium Rx 10 mg Filmovertrukket
English: Belgium Kela Pharma nv Industriepark 68
Danish: Kela Pharma nv Industriepark 68 9100 Sint-Niklaas Belgium
English: Domperidon teva 10 mg film-coated tablet
Danish: Domperidon teva 10 mg filmovertrukket tablet
English: Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris domperidone DOMPERIDONE ZENTIVA 10 mg, comprimé orodispersible
Danish: Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone OROPERIDYS ORODISPERSIBLE TABLETS 10MG
Danish: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone OROPERIDYS OROOPLØSELIG TABLETS 10MG
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone Oroperidys 10 mg 10 mg orodispersible tablet oral use
Danish: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone Oroperidys 10 mg 10 mg oroopløselig tablet Oral anvendelse
English: Healthypharm B.V. Nieuwe Donk 3
Danish: Healthypharm B.V.
English: ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon domperidone DOMPERIDONE ARROW 10 mg, comprimé pelliculé
Danish: ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon
English: Domperidone Motilium 10mg FilmCoated Tablets
Danish: Domperidone Motilium 10mg Filmovertrukk et Tablets
English: Box: 51409
Danish: 1-10 Constantinoupoleos St. P.O. Box: 51409
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone Oroperidys 10 mg orodispersible tablets
Danish: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France domperidone Oroperidys 10 mg smeltetablets
English: Motilium Instants 10 mg orodispersible tablet oral use
Danish: Motilium Instants 10 mg smeltetablet
English: Dubrova 308 52220 Labin Croatia
Danish: Dubrova 308 52220 Labin Kroatien
English: Dental use Perineural use Submucosal use Infiltration
Danish: Dental anvendelse Perineural anvendelse Submukosal anvendelse Infiltration
English: Perineural use Infiltration
Danish: Perineural anvendelse Infiltration
English: Infiltration Perineural use
Danish: Infiltration Perineural anvendelse
English: 3% without vasoconstrictor
Danish: 3% uden vasokonstrikt or
English: Laboratoires Septodont 58, rue du Pont de Créteil 94107 Saint-Maur-des-Fossés Cedex
Danish: Laboratoires Septodont 58, rue du Pont de Créteil 94107 Saint-Maur-desFossés Cedex France
English: Spécialités Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-des-Fossés France
Danish: Spécialités Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-desFossés
English: Laboratoires Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-des-Fossés France
Danish: Laboratoires Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-desFossés
English: Perineural use Submucosal use
Danish: Perineural anvendelse Submukosal anvendelse
English: SCANDONEST 30 MG/ML, SOLUTION INJECTABLE À USAGE DENTAIRE
Danish: MG/ML, SOLUTION INJECTABLE À USAGE DENTAIRE
English: EMA/430531/2016 Rev 1 EMEA/H/C/003846
Danish: EMA/430531/2016 EMEA/H/C/003846
English: What is Kyndrisa?
Danish: Hvad er Kyndrisa?
English: Withdrawal of the marketing authorisation application for Kyndrisa (drisapersen)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Kyndrisa (drisapersen)
English: Kyndrisa is a medicine that contains the active substance drisapersen.
Danish: Kyndrisa er et lægemiddel, der indeholder det aktive stof drisapersen.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med Kyndrisa og har behov for mere information om din behandling, kan du kontakte den læge, der giver dig behandlingen.
English: The company stated that it intended to stop the development of the medicine, but that it plans to work with doctors, patients and local regulatory authorities to allow currently treated patients to access the remaining supply of Kyndrisa.
Danish: Virksomheden har oplyst, at den vil stoppe udviklingen af dette lægemiddel, men at den planlægger at samarbejde med læger, patienter og lokale lægemiddelmyndigheder om at give de aktuelt behandlede patienter mulighed for at få adgang til de resterende forsyninger af Kyndrisa.
English: The Committee considered that data from the clinical studies did not sufficiently demonstrate a beneficial effect of Kyndrisa: the main study did not show any benefit in patients with the condition, while two other studies failed to consistently show a beneficial effect.
Danish: Udvalget vurderede, at data fra de kliniske undersøgelser ikke i tilstrækkelig grad havde påvist en gavnlig virkning ved Kyndrisa: Hovedundersøgelsen påviste ingen virkning hos patienter med lidelsen, mens to andre undersøgelser ikke på konsekvent vis påviste en gavnlig virkning.
English: This medicine works by ‘exon 51 skipping
Danish: Lægemidlet virker i kraft af "exon 51 skipping"-teknologien.
English: What was Kyndrisa expected to be used for?
Danish: Hvad forventedes Kyndrisa anvendt til?
English: How is Kyndrisa expected to work?
Danish: Hvordan forventes Kyndrisa at virke?
English: Kyndrisa was investigated in three studies in a total of 290 patients with Duchenne muscular dystrophy.
Danish: Kyndrisa blev undersøgt i tre undersøgelser med i alt 290 patienter med Duchennes muskeldystrofi.
English: Further, the safety profile of the medicine was not considered satisfactory, particularly because of the risk of persisting reactions at the injection site (such as swelling, inflammation and ulceration) which could have a negative impact on quality of life, and the risk of thrombocytopenia (low blood platelet counts) which could put patients at risk of serious bleeding complications.
Danish: Desuden var lægemidlets sikkerhedsprofil ikke tilfredsstillende, især på grund af risikoen for vedvarende reaktioner på injektionsstedet (f.eks. hævelse, betændelse og sårdannelse), der kunne have en negativ indvirkning på livskvaliteten, og risikoen for trombocytopeni (for lavt antal blodplader), der kunne give patienterne en betydelig risiko for alvorlige blødningskomplikationer.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Kyndrisa did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Kyndrisa ikke opvejede risiciene.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some important unresolved issues.
Danish: Efter at CHMP havde vurderet virksomhedens besvarelse af den sidste række spørgsmål, var der fortsat visse vigtige uafklarede punkter.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it would not be able to address the CHMP concerns regarding the results of the clinical studies within the expected timeframe.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den ikke ville være i stand til at besvare CHMP's betænkeligheder vedrørende resultaterne af de kliniske undersøgelser inden for den forventede tidsramme.