FrancophonIA/ELRC3.0 huggingface dataset:
English: Following a marketing authorisation application to the Federal Office of Consumer Protection and Food Safety of Germany, under Article 13(1) of Directive 2001/82/EC, i.e., a generic application, for the veterinary medicinal product Solupred 125 mg (applicant: CP-Pharma), it appeared that no productspecific residue data are available in support of the cattle meat and offal withdrawal periods of 6 days for the reference products Solu-Medrol 120 mg and Solu-Medrol 500 mg which are authorised in France for use in dogs, cats and cattle (marketing authorisation holder: Zoetis).
Danish: Efter en ansøgning om markedsføringstilladelse til forbundsagenturet for forbrugerbeskyttelse og fødevaresikkerhed i Tyskland, i henhold til artikel 13, stk. 1, i direktiv 2001/82/EF, dvs. en generisk ansøgning for veterinærlægemidlet, Solupred 125 mg (ansøger: CP-Pharma), viste det sig, at ingen data for produktspecifikke restkoncentrationer er tilgængelige til understøttelse af tilbageholdelsesperioden på 6 dage for kød og indmad fra kvæg for referenceprodukterne Solu-Medrol 120 mg og Solu-Medrol 500 mg, der er godkendt i Frankrig til anvendelse på hunde, katte og kvæg (indehaver af markedsføringstilladelse: Zoetis).
English: Germany1 CP-Pharma Handelsgesellschaft mbH Ostlandring 13
Danish: Handelsgesellschaft mbH Ostlandring 13
English: Methylprednisolone hydrogen succinate is an ester of the synthetic glucocorticoid methylprednisolone.
Danish: Methylprednisolonhydrogensuccinat er en ester af det syntetiske glukokortikoid methylprednisolon.
English: In the absence of residue depletion data it cannot be ensured that residue levels are below the MRLs in all edible tissues at 6 days post-treatment.
Danish: I mangel af restkoncentrationsdata kan det ikke garanteres, at restkoncentrationerne ligger under MRL-værdierne i alle spiselige væv 6 dage efter behandlingen.
English: Furthermore, the data from the MRL file on methylprednisolone support the assumption that the potential consumer exposure from injection site residue will be above the pharmacological ADI, indicating a serious risk for consumer safety.
Danish: Derudover understøtter data fra MRL-filen om methylprednisolon den antagelse, at den potentielle forbrugereksponering fra restkoncentrationer på injektionsstedet kan ligge over den farmakologiske ADI og dermed indikere en alvorlig risiko for forbrugersikkerheden.
English: The aim of the referral procedure was to consider all available residue depletion data and recommend withdrawal periods for meat and offal derived from treated cattle.
Danish: Formålet med proceduren for indbringelse af sager var at tage alle tilgængelige restkoncentrationsdata i betragtning og anbefale tilbageholdelsesperioder for kød og indmad, der stammer fra behandlet kvæg.
English: Using the data available in the CVMP EPMAR for methylprednisolone (EMEA/MRL/798/01-FINAL)2, Germany considered that residues of methylprednisolone at injection sites may lead to intake of amounts of methylprednisolone significantly above the Acceptable Daily Intake (ADI).
Danish: På baggrund af data fra CVMP's EPMAR for methylprednisolon (EMEA/MRL/798/01-FINAL)2 finder Tyskland, at koncentrationsrester af methylprednisolon på injektionsstedet kan føre til indtagelse af methylprednisolon i mængder, der ligger betydeligt over det acceptable daglige indtag (ADI).
English: 2 CVMP EPMAR for methylprednisolone (EMEA/MRL/798/01-FINAL)http://www.ema.europa.eu/docs/en_GB/document_library/Maximum_Residue_Limits__Report/2009/11/WC500015081.pdf alcohol) and two antibiotic substances (neomycin and benzylpenicillin).
Danish: 2 CVMP EPMAR for methylprednisolone (EMEA/MRL/798/01-FINAL)http://www.ema.europa.eu/docs/en_GB/document_library/Maximum_Residue_Limits__Report/2009/11/WC500015081.pdf er anvendt i restkoncentrationsundersøgelsen til fastsættelse af maksimalgrænseværdierne for restkoncentrationer (MRL'er) for methylprednisolon, er et kombinationsprodukt indeholdende methylprednisolon (som fri alkohol) og to antibiotiske stoffer (neomycin og benzylpenicillin).
English: • the CVMP considered that a withdrawal period for meat and offal derived from treated cattle cannot be set; the CVMP has recommended the refusal of the granting of the marketing authorisation for the target species cattle and the variation of the existing marketing authorisations in order to remove any reference to the target species cattle for veterinary medicinal products containing methylprednisolone hydrogen succinate as referred in Annex I.
Danish: • CMVP mener, at en tilbageholdelsesperiode for kød og indmad fra behandlet kvæg, ikke kan fastsættes anbefaler CVMP et afslag på ansøgningen om markedsføringstilladelse for målarten kvæg og ændring af de eksisterende markedsføringstilladelser, således at alle henvisninger til målarten kvæg for veterinærlægemidler indeholdende methylprednisolonhydrogensuccinat, som beskrevet i bilag I, fjernes.
English: As no residue depletion data are available for veterinary medicinal products containing methylprednisolone hydrogen succinate, the CVMP is not able to recommend withdrawal periods for meat and offal derived from treated cattle.
Danish: Eftersom ingen restkoncentrationsdata er tilgængelige for veterinærlægemidler indeholdende methylprednisolonhydrogensuccinat, er Udvalget for Lægemidler til Dyr (CVMP) ikke i stand til at anbefale tilbageholdelsesperioder for kød og indmad, der stammer fra behandlet kvæg.
English: No residue depletion data are available for veterinary medicinal products containing methylprednisolone hydrogen succinate.
Danish: Ingen restkoncentrationsdata er tilgængelige for veterinærlægemidler, der indeholder methylprednisolonhydrogensuccinat.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to review all available residue depletion data and recommend withdrawal periods for meat and offal derived from treated cattle.
Danish: Udvalget for Lægemidler til Dyr (CVMP) blev anmodet om at gennemgå alle foreliggende restkoncentrationsdata og anbefale tilbageholdelsestider for kød og indmad fra behandlet kvæg.
English: • the CVMP considered that in the absence of residue depletion data, it cannot be ensured that residue levels are below the MRLs in all edible tissues at 6 days post-treatment;
Danish: • Udvalget for Lægemidler til Dyr mente, at i mangel af restkoncentrationsdata kan det ikke garanteres, at restkoncentrationerne er under MRL-værdierne i alle spiselige væv 6 dage efter behandlingen
English: Therefore, the Committee considers that the benefit-risk balance for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection for use in target species cattle is not favourable in the absence of adequate residue depletion data to justify a withdrawal period of 6 days for cattle (meat and offal).
Danish: Derfor betragter udvalget benefit/risk-forholdet for veterinærlægemidler, der indeholder methylprednisolonhydrogensuccinat i form af injektionsvæske, opløsning, til anvendelse på målarten kvæg, som ikke-favorabel på grund af manglen på tilstrækkelige restkoncentrationsdata til at understøtte en tilbageholdelsesperiode på 6 dage for kvæg (kød og indmad).
English: Consequently, the Committee recommends the refusal of the granting of the marketing authorisation for the target species cattle and the variation of the existing marketing authorisations in order to remove any reference to the target species cattle for veterinary medicinal products containing methylprednisolone hydrogen succinate.
Danish: Derfor anbefaler udvalget et afslag på ansøgningen om udstedelse af markedsføringstilladelse for målarten kvæg og ændring af de eksisterende markedsføringstilladelser, således at alle henvisninger til målarten kvæg for veterinærlægemidler indeholdende methylprednisolonhydrogensuccinat fjernes.
English: Even if formulation differences and differences between the chemical forms of the active substances (methylprednisolone as free alcohol versus methylprednisolone hydrogen succinate) are taken into account, these data strongly indicate that a withdrawal period of 6 days for cattle (meat and offal) treated with methylprednisolone hydrogen succinate-containing products is insufficient to ensure consumer safety.
Danish: Selv hvis formuleringsforskelle og forskelle mellem de kemiske former på de aktive stoffer (methylprednisolon som fri alkohol mod methylprednisolonhydrogensuccinat) tages i betragtning, indikerer disse data tydeligt, at en tilbageholdelsesperiode på 6 dage for kvæg (kød og indmad) behandlet med produkter, der indeholder methylprednisolonhydrogensuccinat, ikke er tilstrækkelig til at garantere forbrugersikkerheden.
English: Even if formulation differences and differences between the chemical forms of the active substances (methylprednisolone as free alcohol versus methylprednisolone hydrogen succinate) are taken into account, Germany considered that these data strongly indicate that a withdrawal period of 6 days for cattle (meat and offal) treated with methylprednisolone hydrogen succinate containing products might not be sufficient to ensure consumer safety.
Danish: Selv hvis formuleringsforskelle og forskelle mellem de kemiske former på de aktive stoffer (methylprednisolon som fri alkohol mod methylprednisolonhydrogensuccinat) tages i betragtning, finder Tyskland, at disse data tydeligt indikerer, at en tilbageholdelsesperiode på 6 dage for kvæg (kød og indmad) behandlet med produkter, der indeholder methylprednisolonhydrogensuccinat, kan være utilstrækkelig til at garantere forbrugersikkerheden.
English: This conclusion applies to the administration of the products via the intramuscular route or the intravenous route.
Danish: Denne konklusion gælder for intramuskulær og intravenøs administration af produkterne.
English: • the CVMP considered that the data from the MRL file for methylprednisolone support the assumption that the potential consumer exposure from injection site residue will be above the pharmacological
Danish: • CVMP mener at data fra MRL-filen om methylprednisolon understøtter den antagelse, at den potentielle forbrugereksponering fra restkoncentrationer på injektionsstedet kan ligge over den farmakologiske ADI og dermed indikere en alvorlig risiko for forbrugersikkerheden
English: Scientific conclusions and grounds for refusal of the granting of the marketing authorisation for the target species cattle and for the variation of the existing marketing authorisations in order to remove any reference to the target species cattle
Danish: Videnskabelige konklusioner og årsager til afslag på ansøgning om markedsføringstilladelse for målarten kvæg og ændring af de eksisterende markedsføringstilladelser, således at alle henvisninger til målarten kvæg fjernes
English: No product specific residue depletion data or any other information concerning residues of veterinary medicinal products containing methylprednisolone hydrogen succinate are available.
Danish: Restkoncentrationsdata for kød og indmad fra kvæg Ingen produktspecifikke restkoncentrationsdata eller andre oplysninger om restkoncentrationer i veterinærlægemidler indeholdende methylprednisolonhydrogensuccinat er tilgængelige.
English: Grounds for refusal of the granting of the marketing authorisation for the target species cattle and for the variation of the existing marketing authorisations in order to remove any reference to the target species cattle
Danish: Årsager til afslag på ansøgning om markedsføringstilladelse for målarten kvæg og ændring af de eksisterende markedsføringstilladelser, således at alle henvisninger til målarten kvæg fjernes
English: Animal species
Danish: Veterinærlægemidlet, der
English: SOLU-MEDROL 500 MG Methylprednisolone hydrogen succinate
Danish: SOLU-MEDROL 500 MG
English: SOLU-MEDROL 120 MG Methylprednisolone hydrogen succinate
Danish: SOLU-MEDROL 120 MG
English: Methylprednisolone hydrogen succinate
Danish: Methylprednisolonhydrogensuccinat Pulver og opløsningsmiddel mg per bottle
English: Route of administration
Danish: Lægemiddelform Styrke Dyrearter Administrationsvej
English: Powder and solvent
Danish: CP-Pharma
English: Lyophilisate and diluent for solution for injection
Danish: Methylprednisolonhydrogensuccinat Lyofilisat og fortyndingsmiddel til injektionsvæske, opløsning mg per bottle
English: This could indeed be done through a type II variation at national level.
Danish: Dette kunne gøres gennem en type II-ændring på nationalt niveau.
English: The referral procedure was then started on 20 September 2007.
Danish: Henvisningsproceduren blev dernæst påbegyndt den 20. september 2007.
English: It is currently authorised in the EU under the different names referred in Annex I.
Danish: Det er på nuværende tidspunkt godkendt i EU under de forskellige navne, der er anført i bilag I.
English: Therefore the CHMP remained of the opinion that this indication should be withdrawn.
Danish: CHMP var derfor fortsat af den overbevisning, at denne indikation skulle trækkes tilbage.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF NORFLOXACIN CONTAINING MEDICINAL PRODUCTS (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LÆGEMIDLER, DER INDEHOLDER NORFLOXACIN (se bilag I)
English: Overall, the responses provided included bibliographical data and a proposal to update the section 5.1 of the SPC.
Danish: Samlet set omfattede de indkomne svar vedlagte bibliografiske data og et forslag om opdatering af produktresuméets afsnit 5.1.
English: Medborgarplatsen 25 118 72 Stockholm Sweden
Danish: Medborgarplatsen 25 118 72 Stockholm Sverige
English: Production and Trading Medicines Averof 19A, Athens, 10433 Greece
Danish: Production and Trading Medicines Averof 19A, Athens, 10433 Grækenland
English: • The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing norfloxacin;
Danish: • CHMP behandlede den indbringelse, der havde fundet sted i henhold til artikel 31 i direktiv 2001/83/EF, som ændret, for lægemidler, som indeholder norfloxacin,
English: Only 3 MAHs answered to this List of outstanding issues adopted in May 2008.
Danish: Kun 3 indehavere af markedsføringstilladelse svarede på denne liste over uafklarede spørgsmål, der blev vedtaget i maj 2008.
English: AstraZeneca AB 151 85 Södertälje Sweden
Danish: AstraZeneca AB 151 85 Södertälje Sverige
English: Most of the Marketing Authorisation Holders (MAHs) involved in the referral did not provide any answer to the list of questions adopted by the CHMP in September 2007, when the procedure was initiated.
Danish: De fleste af de indehavere af markedsføringstilladelse, som proceduren angår, fremlagde ingen svar på den liste over spørgsmål, som CHMP vedtog i september 2007, da proceduren blev indledt.
English: London W5 5TL, United Kingdom
Danish: London W5 5TL, Storbritannien
English: Alternova AB Vallgatan 11 170 67 Solna Sweden
Danish: Alternova AB Vallgatan 11 170 67 Solna Sverige
English: D-53125 Bonn Germany
Danish: D-53125 Bonn Tyskland
English: I-27010 Valle Salimbene (PV) Italy
Danish: I-27010 Valle Salimbene (PV) Itaien
English: Korinthou 12, N. Psychiko, 15451 Greece
Danish: Korinthou 12, N. Psychiko, 15451 Grækenland
English: 6 Km Markopoulo-Koropi Avenue Markopoulo Mesogeion 19003 Greece
Danish: 6 Km Markopoulo-Koropi Avenue Markopoulo Mesogeion 19003 Grækenland
English: Specifar Abee 28th October Street No 1 Agia Barbara 12351 Greece
Danish: Specifar Abee 28th October Street No 1 Agia Barbara 12351 Grækenland
English: Avgis & Gallinis 15, N. Kifissia Greece
Danish: Avgis & Gallinis 15, N. Kifissia Grækenland
English: D-01309 Dresden Germany
Danish: D-01309 Dresden Tyskland
English: 15 Bd Charles de Gaulle 92700 Colombes France
Danish: 15 Bd Charles de Gaulle 92700 Colombes Frankrig
English: Vilco S.A Pefkon Street 121 N. Irakleion 14122 Greece
Danish: Vilco S.A Pefkon Street 121 N. Irakleion 14122 Grækenland
English: Laboratoire RPG 4 place Louis Armand 75012 Paris France
Danish: Laboratoire RPG 4 place Louis Armand 75012 Paris Frankrig
English: Via Mario Lalli, 8 - 56127 Pisa Italy
Danish: Via Mario Lalli, 8 - 56127 Pisa Italien
English: However the CHMP welcomed the idea to update the MIC breakpoints in section 5.1 of the SPC to include the clinical MIC breakpoints as defined by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) in section 5.1 of the SPC as these breakpoints are not only related to the pathogens found in complicated pyelonephritis, but to common urinary pathogens found in other urinary indications.
Danish: CHMP var dog imødekommende over for idéen om at opdatere de MIC breakpoints, der er angivet i produktresuméets afsnit 5.1, således at dette afsnit også inkluderer de kliniske MIC breakpoints, der er fastlagt af European Committee on Antimicrobial Susceptibility Testing (EUCAST), da disse breakpoints ikke kun vedrører de patogener, der optræder ved kompliceret pyelonefritis, men også almindelige urinpatogener, som findes i forbindelse med andre indikationer relateret til urinvejene.
English: Via A. Fleming 2 - 37135 Verona Italy
Danish: Via A. Fleming 2 - 37135 Verona Italien
English: However the CHMP requested a more detailed review of all relevant data specifically on resistance to common urinary pathogens and the possible consequences on the section 5.1 of the SPC before the final conclusion could be made, which lead to the adoption of a List of Outstanding Issues.
Danish: CHMP anmodede dog om en mere detaljeret gennemgang af alle relevante data, især de data, der vedrører resistens mod almindelige urinpatogener og de mulige følger heraf i produktresuméets afsnit 5.1, før der kunne træffes en endelig beslutning.
English: Ratiopharm Hungária Kft. 1145 Budapest Uzsoki u. 36/a Hungary
Danish: Ratiopharm Hungária Kft. 1145 Budapest Uzsoki u. 36/a Ungarn
English: Via dei Castelli Romani 22 - 00040 Pomezia (RM) Italy
Danish: Via dei Castelli Romani 22 - 00040 Pomezia (RM) Italien
English: Largo Umberto Boccioni, 1 21040 - Origgio (VA) Italy
Danish: Largo Umberto Boccioni, 1 21040 - Origgio (VA) Italien
English: Alacan S.A Capricornio, 5, 03006 Alicante, Spain
Danish: Alacan S.A Capricornio, 5, 03006 Alicante, Spanien
English: Docpharma N.V Ambachtenlaan 13H 3001 Heverlee Belgium
Danish: Docpharma N.V Ambachtenlaan 13H 3001 Heverlee Belgien
English: Ratiopharm Belgium S.A Rue St-Lambert 141 1200 Bruxelles Belgium
Danish: Ratiopharm Belgium S.A Rue St-Lambert 141 1200 Bruxelles Belgien
English: AC Helcor Hungary Kft 1131 Budapest, Madarász Viktor u.27 Hungary
Danish: AC Helcor Hungary Kft 1131 Budapest, Madarász Viktor u.27 Ungarn
English: Old Post House, Hithrow Road, Webbger Bridge, Surrey KT 138TS United Kingdom
Danish: Old Post House, Hithrow Road, Webbger Bridge, Surrey KT 138TS Storbritannien
English: Ratiopharm Nederland BV, Ronde Tocht 11, 1507 CC Zaandam, The Netherlands
Danish: Ratiopharm Nederland BV, Ronde Tocht 11, 1507 CC Zaandam, Holland
English: Stada Arzneimittel Stadastrasse 2-18 DE-61118 Bad Vilbel Germany
Danish: Stada Arzneimittel Stadastrasse 2-18 DE-61118 Bad Vilbel Tyskland
English: Actavis Italy SpA V.Jose'Escrivia De Balaguer, 6 21047 Saronno (VA) Italy
Danish: Actavis Italy SpA V.Jose'Escrivia De Balaguer, 6 21047 Saronno (VA) Italien
English: Belgium triggered a referral procedure on 14 September 2007 and requested the CHMP to give its opinion on whether the marketing authorisations for oral formulations of products containing norfloxacin in the treatment of acute or chronic complicated or uncomplicated pyelonephritis should be maintained, varied, suspended or withdrawn across the European Union following the reassessment of norfloxacin benefit/risk balance.
Danish: Belgien indledte en henvisningsprocedure den 14. september 2007 og anmodede CHMP om at give en udtalelse om, hvorvidt markedsføringstilladelserne for perorale formuleringer af lægemidler, der indeholder norfloxacin, til behandling af akut eller kronisk kompliceret eller ukompliceret pyelonefritis skulle opretholdes, ændres, suspenderes eller trækkes tilbage i hele Den Europæiske Union efter revurderingen af benefit/risk-forholdet for norfloxacin.
English: 49, avenue Georges Pompidou 92300 Levallois-Perret France
Danish: 49, avenue Georges Pompidou 92300 Levallois-Perret Frankrig
English: 7 - 20144 Milano Italy
Danish: 7 - 20144 Milano Italien
English: Vianex S.A Tatoiou Street Nea Erythrea 14671 Greece
Danish: Vianex S.A Tatoiou Street Nea Erythrea 14671 Grækenland
English: As a response to CHMP, most of the MAHs proposed to withdraw the indication in question, while some MAHs chose to submit bibliographic data, because no unpublished data from clinical trials were available to them.
Danish: Som svar til CHMP foreslog de fleste indehavere af markedsføringstilladelse at trække den pågældende indikation tilbage, men nogle indehavere af markedsføringstilladelse indsendte dog bibliografiske data, idet de ikke var i besiddelse af ikke-publicerede data fra kliniske undersøgelser.
English: Socobom N.V Louizalaan 149 B24 1050 Brussel Belgium
Danish: Socobom N.V Louizalaan 149 B24 1050 Brussel Belgien
English: Via Pavia 6, 20131 Milano Italy
Danish: Via Pavia 6, 20131 Milano Italien
English: Further to the discussion held in May 2008, the CHMP agreed that the second generation of fluoroquinolones result in higher serum concentrations than norfloxacin.
Danish: I forlængelse af drøftelsen i maj 2008 vedtog CHMP, at andengenerations-fluoroquinolonerne giver højere serumkoncentrationer end norfloxacin.
English: Almirall Prodesfarma S.A Ronda General Mitre, 151, 08022 Barcelona, Spain
Danish: Almirall Prodesfarma S.A Ronda General Mitre, 151, 08022 Barcelona, Spanien
English: D-82041 Oberhaching Germany
Danish: D-82041 Oberhaching Tyskland
English: Merck Generics BV, Dieselweg 25, 3752 LB Bunschoten, The Netherlands
Danish: Merck Generics BV, Dieselweg 25, 3752 LB Bunschoten, Holland
English: Arrow Generiques 26 av Tony Garnier 69007 Lyon France
Danish: Arrow Generiques 26 av Tony Garnier 69007 Lyon Frankrig
English: via Felice Casati, 16 - 20124 Milano Italy
Danish: via Felice Casati, 16 - 20124 Milano Italien
English: 92517 Boulogne Billancourt Cedex France
Danish: 92517 Boulogne Billancourt Cedex Frankrig
English: • The Committee, as a consequence, concluded that the benefit/risk balance of oral norfloxacin containing medicinal products is negative in the above indication.
Danish: • CHMP konkluderede følgelig, at benefit/risk-forholdet for perorale lægemidler, der indeholder norfloxacin, er negativt ved ovennævnte indikation.
English: D-40789 Monheim Germany
Danish: D-40789 Monheim Tyskland
English: Sandoz B.V., Veluwezoom 22, 1327 AH Almere, The Netherlands
Danish: Sandoz B.V., Veluwezoom 22, 1327 AH Almere, Holland
English: Merck Sharp & Dohme BV, Waarderweg 39, NL-2031 BN Haarlem, The Netherlands
Danish: Merck Sharp & Dohme BV, Waarderweg 39, NL-2031 BN Haarlem, Holland
English: Biosarto, S.A Foc, 68-82, 08038 Barcelona, Spain
Danish: Biosarto, S.A Foc, 68-82, 08038 Barcelona, Spanien
English: S.C Terapia S.A Str. Fabricii nr. 124, Zip code : 400640 Cluj Napoca, România
Danish: S.C Terapia S.A Str. Fabricii nr. 124, Zip code : 400640 Cluj Napoca, Rumænien
English: The CHMP therefore concluded on 24 July 2008 that for oral norfloxacin containing medicinal products the benefit does not outweigh the risk in complicated pyelonephritis.
Danish: CHMP konkluderede derfor den 24. juli 2008, at fordelene ved perorale lægemidler, der indeholder norfloxacin, ikke opvejer risikoen i forbindelse med kompliceret pyelonefritis.
English: Sharp & Dohme, S.A Josefa Valcárcel, 38 28027 Madrid Spain
Danish: Sharp & Dohme, S.A Josefa Valcárcel, 38 28027 Madrid Spanien
English: Quimifar, S.A Comadran, 37, 08210 Barbera del Valles, Spain
Danish: Quimifar, S.A Comadran, 37, 08210 Barbera del Valles, Spanien
English: Ranbaxy (UK) Ltd., 20 Balderton Street, London W1K6TL United Kingdom
Danish: Ranbaxy (UK) Ltd., 20 Balderton Street, London W1K6TL Storbritannien