FrancophonIA/ELRC3.0 huggingface dataset:
English: As significant deficiencies were noted in the proprietary clinical studies conducted with Fiprex, these data were not considered reliable.
Danish: Da der blev fundet væsentlige mangler i de interne kliniske undersøgelser, der er udført med
English: Overall summary of the scientific evaluation of Fiprex CAT 52.5 mg spot-on solution for cats, Fiprex S 75 mg spot-on solution for dogs, Fiprex M 150 mg spot-on solution for dogs, Fiprex L 300 mg spot-on solution for dogs and Fiprex XL 412.5 mg spot-on solution for dogs (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Fiprex CAT, spot-on, opløsning, 52,5 mg, til katte, Fiprex S, spot-on, opløsning, 75 mg, til hunde, Fiprex M, spot-on, opløsning, 150 mg, til hunde, Fiprex L, spot-on, opløsning, 300 mg, til hunde og Fiprex XL, spot-on, opløsning, 412,5 mg, til hunde (se bilag I)
English: In accordance with the legal basis of the application, i.e. well established use, the MAH has cited published literature to support the efficacy of the product.
Danish: Til dokumentation af produktets virkning har indehaveren af markedsføringstilladelsen refereret til publiceret litteratur i overensstemmelse med ansøgningens retlige grundlag, dvs. almindelig anvendelse.
English: Therefore, the CVMP recommended the refusal of the granting of the marketing authorisation for Fiprex CAT 52.5 mg spot-on solution for cats, Fiprex S 75 mg spot-on solution for dogs, Fiprex M 150 mg spot-on solution for dogs, Fiprex L 300 mg spot-on solution for dogs, Fiprex XL 412.5 mg spot-on solution for dogs and the suspension of the existing marketing authorisations (see Annex I).
Danish: • CVMP fandt, at der ud fra ansøgningens dokumentation ikke kan fastlægges et positivt benefit/risk-forhold for produktet anbefalede CVMP afslag på ansøgning om markedsføringstilladelse for Fiprex CAT, spot-on, opløsning, 52,5 mg, til katte, Fiprex S spot-on, opløsning, 75 mg, til hunde, Fiprex M, spot-on, opløsning, 150 mg, til hunde, Fiprex L, spot-on, opløsning, 300 mg, til hunde og Fiprex XL, spot-on, opløsning, 412,5 mg, til hunde, og suspendering af de eksisterende markedsføringstilladelser (se bilag I).
English: Greece
Danish: Slovakiet
English: Based on the accepted well-established use substantiated by the MAH through public literature within their application, the Committee was able to conclude that the target animal safety was adequately supported.
Danish: Udvalget konkluderede, at sikkerheden hos de dyrearter, som lægemidlet er beregnet til, var tilstrækkelig godtgjort på grundlag af almindelig anvendelse, som indehaveren af markedsføringstilladelsen havde dokumenteret med litteraturdata.
English: The Netherlands 1
Danish: Tjekkiet1
English: Fiprex L 300 mg spoton løsning for hunde
Danish: Fiprex L 300 mg spot on løsning for hunde
English: Fiprex M 150 mg spoton løsning for hunde
Danish: Fiprex M 150 mg spot on løsning for hunde
English: Pergolide containing medicinal products with Marketing Authorisation in the European Union
Danish: Lægemidler indeholdende pergolid med markedsføringstilladelse i EU
English: France société TEVA CLASSICS, Le pallatin 1, 1 cour du triangle, 92936 Paris la défence cedex, France
Danish: Frankrig société TEVA CLASSICS, Le pallatin 1, 1 cour du triangle, 92936 Paris la défence cedex, France
English: APOTHECON B.V. Nijverheidsweg 3 3771 ME Barneveld
Danish: Nijverheidsweg 3 3771 ME Barneveld
English: Cabergoline containing medicinal products with Marketing Authorisation in the European Union
Danish: Lægemidler indeholdende cabargolin med markedsføringstilladelse i EU
English: United Kingdom GENERICS (UK) Limited, Station Close, Potters Bar, Herts EN6 1TL, UK
Danish: GENERICS (UK) Limited, Station Close, Potters Bar, Herts EN6 1TL, UK
English: Radlická 3185/1C, Praha 5 Czech Republic
Danish: Radlická 3185/1C, Praha 5
English: EUROGENERICS N.V. Heizel Esplanade b22 1020 Brussels, Belgium
Danish: Heizel Esplanade b22 1020 Brussels, Belgium
English: PHARMACHEMIE B.V.; Swensweg 5; Haarlem/NL, Netherlands
Danish: ; Swensweg 5; Haarlem/NL, Netherlands
English: SANDOZ B.V.; Veluwezoon 22; 1327 AH ALMERE/NL, Netherlands
Danish: ; Veluwezoon 22; 1327 AH ALMERE/NL, Netherlands
English: United Kingdom SANDOZ Limited, Woolmer Way, Borden, Hampshire GU35 9QE, UK
Danish: SANDOZ Limited, Woolmer Way, Borden, Hampshire GU35 9QE, UK
English: AbZ-PHARMA Graf-Arco-Str. 3
Danish: Graf-Arco-Str. 3
English: 15th km National Highway Athens-Lamia, Kifissia 14564, P.O.
Danish: 15th km National Highway Athens-Lamia, Kifissia 14564, P.O. BOX 51288, Greece
English: MERCK GENERICS B.V.; Dieselweg 26; 3752 LB Bunschoten/NL, Netherlands
Danish: ; Dieselweg 26; 3752 LB Bunschoten/NL, Netherlands
English: TEVA Pharma Belgium N.V. , Laarstraat 16 B-2610 Wilrijk, Belgium
Danish: , Laarstraat 16 B-2610 Wilrijk, Belgium
English: Iceland
Danish: Islanda
English: United Kingdom NORTON HEALTHCARE Limited, Albert Basin, Royal Docks, London E16 2QJ, UK
Danish: NORTON HEALTHCARE Limited, Albert Basin, Royal Docks, London E16 2QJ, UK
English: IVAX Farma b.v. Tolnasingel 3 2411 PV Bodegraven, Netherlands
Danish: Tolnasingel 3 2411 PV Bodegraven, Netherlands
English: Box 1070 251 10 Helsingborg, Sweden
Danish: TEVA Sweden AB, Sundstorget 2, Helsingborg P.O. Box 1070 251 10 Helsingborg, Sweden
English: Box 43011 3540 AA Utrecht, The Netherlands
Danish: TEVA Pharma B.V., P.O. Box 43011 3540 AA Utrecht, The Netherlands
English: United Kingdom PHARMACIA Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK
Danish: PHARMACIA Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK
English: TEVA Pharma B.V., P.O.
Danish: APOTHECON B.V.
English: The CHMP noted:
Danish: CHMP bemærkede:
English: Notwithstanding this fact, the safety profile of the product is of concern.
Danish: På trods af dette giver produktets sikkerhedsprofil anledning til bekymring.
English: ABS is generally a non-severe infection associated with high spontaneous cure rates (90%).
Danish: ABS er generelt en ikke-alvorlig infektion, der forbindes med en høj grad af spontan helbredelse (90 %).
English: A substantial proportion of prescriptions for sinusitis in clinical practice may be empirical and without confirmation of bacterial origin.
Danish: En væsentlig andel af recepterne ved bihulebetændelse i klinisk praksis kan være empirisk og uden bekræftelse af bakteriel oprindelse.
English: A cumulative review up to 30 September 2007 of all hepatic reactions (serious and non-serious) and an overall assessment of the benefit/risk ratio of moxifloxacin treatment was performed.
Danish: Der blev udført en samlet evaluering frem til 30. september 2007 af alle hepatiske bivirkninger (alvorlige og ikke-alvorlige) og en samlet vurdering af benefit/risk-forholdet for moxifloxacin-behandling.
English: Moxifloxacin is a fluoroquinolone antibiotic with a broad spectrum of activity and bactericidal action.
Danish: Moxifloxacin er et fluoroquinolont antibiotikum med bredspektret aktivitet og baktericid virkning.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ORAL FORMULATIONS OF MOXIFLOXACIN CONTAINING MEDICINAL PRODUCTS (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF ORALE FORMULERINGER AF MOXIFLOXACIN-HOLDIGE LÆGEMIDLER (se bilag I)
English: In 3 of these, moxifloxacin was used for treating less severe indications (sinusitis, pharyngitis and acute bronchitis).
Danish: I tre af disse tilfælde blev moxifloxacin benyttet til behandling af mindre alvorlige indikationer (bihulebetændelse, faryngitis og akut bronkitis).
English: Therefore, since the impact of the choice of an antibiotic therapy for AECB on the outcome of the patients remains unclear, the safety profile of the different antibiotherapy options must be considered.
Danish: Eftersom virkningen på patienterne af valget af en behandling med antibiotika mod AECB fortsat er uklar, skal sikkerhedsprofilen for de forskellige valgmuligheder for antibiotikabehandling tages i betragtning.
English: Clinical trial and published data indicate that moxifloxacin generally has benefits in the indication CAP.
Danish: De kliniske undersøgelser og publicerede data tyder på, at moxifloxacin generelt har fordele ved indikationen CAP.
English: Although moxifloxacin has shown to be effective, the available data is limited as studies have been mainly performed against comparators and the only placebo controlled study failed to demonstrate statistical superiority over placebo.
Danish: Selv om moxifloxacin har vist sig at have en effekt, er mængden af tilgængelige data begrænset, da der hovedsagligt er udført undersøgelser imod komparatorer, og det lykkedes ikke ved den eneste placebo-kontrollerede undersøgelse at påvise statistisk overlegenhed i forhold til placebo.
English: The benefit of antibiotic treatment of AECB was supported by several publications including a metaanalysis and by a recent systematic review from Cochrane Centre suggesting a mortality benefit with the use of antibiotics in this indication in comparison with placebo and a beneficial effect on lung function.
Danish: Fordelen ved antibiotisk behandling af AECB blev understøttet af adskillige publikationer, herunder en metaanalyse, og af en nylig systematisk gennemgang fra Cochrane Centre, som antyder nedsat dødelighed ved brug af antibiotika til denne indikation sammenlignet med placebo og en gavnlig virkning for lungefunktionen.
English: However, it was noted that until recently antibiotic comparative trials in AECB designed to show equivalence between medicinal products did not demonstrate clinical superiority of any class of antibiotics over another.
Danish: Det blev dog bemærket, at der ved sammenlignende undersøgelser af anvendt antibiotika foretaget af AECB, der er designet til at vise ækvivalensen mellem lægemidler, indtil for nylig ikke er påvist klinisk overlegenhed i nogen klasse af antibiotika i forhold til de øvrige.
English: The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing moxifloxacin in oral formulations.
Danish: Udvalget fulgte proceduren i artikel 107 i direktiv 2001/83/EF, med senere ændringer, for lægemidler, der indeholder moxifloxacin i orale formuleringer.
English: Considering the higher incidence of serious and even life-threatening risks in the treatment of an infection which has a high spontaneous resolution rate without antibiotics was considered of concern.
Danish: Den højere forekomst af alvorlige og sågar livstruende risici ved behandling af en infektion, som har en høj forekomst af spontan helbredelse uden antibiotika, blev anset for at give anledning til bekymring.
English: Of a total of 48 identified cases of possibly moxifloxacin-related liver disorders with a fatal outcome of any cause, 8 were suspected cases of moxifloxacin-induced fatal hepatotoxicity.
Danish: Ud af et samlet antal på 48 identificerede tilfælde af mulige moxifloxacin-relaterede leverlidelser med dødelig udgang uanset årsag, blev 8 tilfælde mistænkt for at være moxifloxacin-induceret fatal hepatotoksicitet.
English: These findings and additional available data (observational study and clinical trials) suggested that serious liver injuries occurred more frequently with moxifloxacin then with the comparators.
Danish: Disse fund og yderligere tilgængelige data (observationelle undersøgelser og kliniske undersøgelser) tydede på, at alvorlige leverskader forekom hyppigere med moxifloxacin end med komparatorerne.
English: Moxifloxacin has shown efficacy in all of the approved indications.
Danish: Det har vist sig, at moxifloxacin har en effekt til alle de godkendte indikationer.
English: The CHMP, as a consequence recommended amendments to the relevant sections of the summary of product characteristics and package leaflet for the medicinal products containing moxifloxacin (see Annex III).
Danish: CHMP anbefalede derfor, at der blev foretaget ændringer i de relevante afsnit af produktresuméerne og indlægssedlerne for de lægemidler, der indeholder moxifloxacin (se bilag III).
English: Additionally, most of the phase III studies designed for non-inferiority for moxifloxacin did not use the recommended agent of choice.
Danish: Ydermere benyttede de fleste af de fase III-undersøgelser, som var designet til at påvise, at moxifloxacin ikke vare ringere, ikke det anbefalede foretrukne stof.
English: Furthermore, when taking into account other antiobiotherapy available and resistance, some times advantages over other therapies are observed in the treatment of CAP of mild to moderate severity.
Danish: Hvis andre antibiotiske behandlinger og resistens tages i betragtning, er der i nogle tilfælde desuden observeret fordele i forhold til andre behandlinger i behandlingen af CAP-tilfælde af lav til moderat sværhed.
English: In line with the safety profile, and considering that AECB can be a less severe infection, with high spontaneous resolution rate for which bacteria can be found in only 50% of all exacerbations, the benefit risk can only be considered favourable if moxifloxacin is not used as the first line treatment option.
Danish: I overensstemmelse med sikkerhedsprofilen og i betragtning af, at AECB kan være en mindre alvorlig infektion med en høj grad af spontan helbredelse, og for hvilken der kun i 50 % af tilfældene kan findes bakterier, kan benefit/risk-forholdet kun være positivt, hvis moxifloxacin ikke er den behandlingsmulighed, der vælges først.
English: However, the benefit risk of moxifloxacin may be favourable if other antibiotherapy has failed or cannot be used.
Danish: Benefit/risk-forholdet for moxifloxacin kan dog være positivt, hvis anden antibiotikabehandling ikke har vist resultat eller ikke kan anvendes.
English: The CHMP reviewed all of the information made available by marketing authorisation holders (MAH) on the balance of benefits and risks of oral moxifloxacin in the above indications.
Danish: CHMP gennemgik alle de oplysninger, som indehaverne af markedsføringstilladelserne havde indsendt om benefit/risk-forholdet for oral moxifloxacin til de ovenstående indikationer.
English: Severe hepatotoxicity, cardiac toxicity including QTc interval prolongation, severe skin reactions, Clostridium difficile associated colitis, tendon and muscular toxicity (including rhabdomyolysis) are important identified risks of the treatment with moxifloxacin which are already described in the product information (PI) and under close monitoring.
Danish: Alvorlig hepatoksicitet, kardiotoksicitet, herunder forlænget QTc-interval, alvorlige hudreaktioner, Clostridium difficile-associeret kolitis, sene- og muskeltoksicitet (herunder rhabdomyolyse) er vigtige identificerede risici ved behandling med moxifloxacin, som allerede er beskrevet i produktoplysningerne, og som overvåges nøje.
English: In view of the safety available data the Committee concluded that cases of fatal hepatotoxicity, risk factors for QTc interval prolongation should be reflected in the product information, and that the warnings on Clostridium difficille-associated colitis and bullous skin reactions should be strengthen.
Danish: På baggrund af de tilgængelige sikkerhedsdata konkluderede udvalget, at tilfælde af fatal hepatotoksicitet, risikofaktorer for forlænget QTc-interval skal afspejles i produktoplysningerne, og at advarslerne om Clostridium difficille-associeret kolitis og bulløse hudreaktioner skal styrkes.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉERNE OG INDLÆGSSEDLERNE
English: In view of the available data the Committee concluded that the benefit risk balance of moxifloxacin containing medicinal products in oral formulations in the approved indications under review is favourable as second line indications.
Danish: På basis af de tilgængelige oplysninger konkluderede udvalget, at det foreliggende benefit/riskforhold for moxifloxacin-holdige lægemidler i orale formuleringer til de pågældende godkendte indikationer er tilfredsstillende som andetvalgsindikationer.
English: Based on the above, on 2 June 2008, the UK issued a Rapid Alert informing Members States, the European Medicines Agency (EMEA) and the European Commission (EC) in accordance with Article 107 of Directive 2001/83/EC, as amended of its intention to vary the marketing authorisation of all oral formulations of moxifloxacin containing medicinal products to remove the indications in ABS and AECB and to restrict the indication in CAP.
Danish: På baggrund af ovenstående udsendte Det Forenede Kongerige en varslingsmeddelelse, som i henhold til artikel 107 i direktiv 2001/83/EF, med senere ændringer, informerede medlemsstaterne, Det Europæiske Lægemiddelagentur (EMEA) og Kommissionen om dets beslutning om at ændre markedsføringstilladelserne for alle orale formuleringer af moxifloxacin-holdige lægemidler for at fjerne indikationen til behandling af ABS og AECB og begrænse indikationen til behandling af CAP.
English: In the European Union (EU), Moxifloxacin film coated tablet are indicated for the treatment of acute bacterial sinusitis (ABS), acute exacerbation of chronic bronchitis (AECB) and community acquired pneumonia (CAP) except severe cases, at the dose of 400 mg daily for 7 days for ABS, 5-10 days for AECB and for 10 days for CAP.
Danish: I Den Europæiske Union (EU) er filmovertrukne moxifloxacin-tabletter indiceret til behandling af akut bakteriel bihulebetændelse (ABS), akut forværret kronisk bronkitis (AECB) og lungebetændelse erhvervet uden for hospital (CAP) - med undtagelse af svære tilfælde - med en dosis på 400 mg dagligt i 7 dage mod ABS, 5-10 dage mod AECB og 10 dage mod CAP. I EU er moxifloxacin godkendt i alle medlemsstater via proceduren for gensidig anerkendelse eller nationale procedurer.
English: In ABS and AECB, moxifloxacin should only be used when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed to resolve the infection.
Danish: Ved ABS og AECB bør moxifloxacin kun benyttes, hvis det vurderes uhensigtsmæssigt at benytte antibakterielle stoffer, der almindeligvis anbefales til indledende behandling af disse infektioner, eller hvis disse ikke har afhjulpet infektionen.
English: In CAP, it is to be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection.
Danish: Ved CAP bør det kun benyttes, hvis det vurderes uhensigtsmæssigt at benytte antibakterielle stoffer, der almindeligvis anbefales til indledende behandling af denne infektion.
English: However, considering the safety profile with observed increased incidence of risks, moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection.
Danish: Hvis man tager sikkerhedsprofilen for den observerede øgede risikoforekomst i betragtning, bør moxifloxacin dog kun benyttes, hvis det vurderes uhensigtsmæssigt at benytte de antibakterielle stoffer, der almindeligvis anbefales til indledende behandling af denne infektion.
English: In October 2007, the assessment of the 15th and 16th PSUR for moxifloxacin identified major safety concerns including life threatening hepatotoxicity cases.
Danish: PSUR for moxifloxacin identificeret store sikkerhedsproblemer, herunder livstruende tilfælde af hepatotoksicitet.
English: ANNEX II THE SCIENTIFIC CONCLUSIONS AND THE GROUNDS FOR AMENDMENTS OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET OG INDLÆGSSEDLEN FREMLAGT AF EMEA
English: nd line treatment in the indications for moxifloxacin containing medicinal products (oral formulation) and further amendments to the PI, to include fatal hepatotoxicity cases, risk factors for QTc interval prolongation, and strengthen the warnings on Clostridium difficille-associated colitis and bullous skin reactions.
Danish: På baggrund af ovenstående oplysninger anbefalede CHMP begrænsning af andetvalgsbehandling ved indikationer for moxifloxacin-holdige lægemidler (oral formulering) og yderligere ændringer i produktoplysningerne, sådan at den også omfatter tilfælde af hepatotoksicitet, risikofaktorer for forlænget QTc-interval, og styrkelse af advarslerne mod Clostridium difficille-associeret kolitis og bulløse hudreaktioner.
English: • parental and family leave.
Danish: • forældre- og familieorlov.
English: • Letter from the president of the European Parliament.
Danish: • Brev fra formanden for Europa-Parlamentet.
English: The date of the visit is to be confirmed.
Danish: Datoen for besøget skal bekræftes.
English: Olympics 2012
Danish: Olympiaden 2012
English: Best practices among the audited agencies will be identified.
Danish: Bedste praksis blandt de reviderede agenturer vil blive identificeret.
English: • Revised draft Agenda version 4.0.
Danish: • Revideret udkast til dagsorden version 4.0.
English: It was suggested to have a closer look at minor species in future.
Danish: Det blev foreslået, at man fremover skulle se nærmere på mindre arter.
English: Such members, however, will have to make a considered choice in light of the current policy.
Danish: Sådanne medlemmer vil imidlertid skulle foretage et velovervejet valg i lyset af den nuværende politik.
English: The current practice has been to adopt decisions by consensus.
Danish: Den nuværende praksis har været at vedtage beslutninger med konsensus.
English: The policy for experts was implemented on 29 September 2011, with declarations of experts published on 30 September.
Danish: Politikken for eksperter blev gennemført den 29. september 2011, med erklæringer fra eksperter offentliggjort den 30. september.
English: The scheme will continue in 2012.
Danish: Ordningen vil fortsætte i 2012.
English: Implementation of the EMA road map to 2015
Danish: Gennemførelse af EMA's køreplan frem til 2015
English: The revenue is in line with the forecast, while expenditure is lower than planned.
Danish: Indtægterne følger prognosen, mens udgifterne ligger under det planlagte niveau.
English: • The Innovation Partnership on Active and Healthy Ageing (first areas of work have been identified).
Danish: • Innovationspartnerskabet om aktiv og sund aldring (det første arbejdsområde er blevet identificeret).
English: The policy does not cover staff and experts working in national competent authorities.
Danish: Politikken dækker ikke personale og eksperter, der arbejder i nationale kompetente myndigheder.
English: The rules were sent to the European Commission for approval and the dialogue is ongoing.
Danish: Reglerne blev sendt til Europa-Kommissionen til godkendelse, og der pågår en dialog.
English: More video-conferencing will be held during the Olympic period.
Danish: Der vil blive afholdt flere videokonferencer under Olympiaden.
English: • The revised proposal on information to patients is expected to be adopted on 11 October 2011.
Danish: • Det reviderede forslag om information til patienter forventes at blive vedtaget den 11. oktober
English: The need for a bridging budget for EMA is being discussed).
Danish: Behovet for et overgangsbudget for EMA diskuteres p.t.).
English: The meetings which cannot be cancelled or postponed during the peak Olympic period in the months of July and August 2012 will be hosted at other locations.
Danish: De møder, der ikke kan aflyses eller udsættes i de mest travle perioder under Olympiaden i juli og august 2012, vil blive afholdt andre steder.
English: The above case and the overall transparency policy had an impact on the number of requests for access to documents, which totalled 800,000 pages in the first half of the year.
Danish: Ovennævnte sag og den generelle gennemsigtighedspolitik havde en virkning på antallet af anmodninger om aktindsigt i dokumenter, der udgjorde i alt 800 000 sider i årets første halvdel.
English: Visit by the delegation of the European Parliament Committee on Environment, Public Health and Food Safety
Danish: Besøg af delegationen fra Europa-Parlamentets Udvalg om Miljø, Folkesundhed og Fødevaresikkerhed