FrancophonIA/ELRC3.0 huggingface dataset:
Danish: Søvnapnø og pludselig død er indberettet fra klinisk praksis efter initiering af behandlingen hos patienter med Prader-Willis syndrom med en eller flere af følgende risikofaktorer: svær fedme, tidligere øvre luftvejsobstruktion eller søvnapnø, og uidentificeret luftvejsinfektion.
Maltese: L-apnea waqt l-irqad u mwiet f'daqqa kienu rrapportati fil-prattika klinika wara l-bidu ta' terapija f'pazjenti bis-sindromu ta' Prader-Willi li kellhom wieħed jew aktar mill-fatturi ta' riskju li ġejjin: obeżità severa, storja ta' ostruzzjoni tal-passaġġ ta' fuq tan-nifs jew apnea waqt l-irqad, jew infezzjoni respiratorja mhux identifikata.
Danish: • udvalget behandlede anmeldelsen af den indbringelse, der var indledt at Danmark i henhold til artikel 13 i Kommissionens forordning (EF) nr. 1234/2008,
Maltese: Regolament tal-Kummissjoni (KE) Nru 1234/2008.
Danish: Videnskabelige konklusioner og begrundelse for afslaget fremlagt af EMA
Maltese: Konklużjonijiet xjentifiċi u r-raġunijiet għar-rifjut ippreżentati mill-EMA
Danish: Der blev i alt indberettet 128 tilfælde af bivirkninger hos 31 (75,6 %) af børn med PWS under eksponeringen for Norditropin (gennemsnitlig eksponeringsvarighed 4,1 år, område 0,3 til 9,5 år).
Maltese: 6%) tifel u tifla b'PWS matul lespożizzjoni bi Norditropin (espożizzjoni medja ta' 4.1 snin, medda ta' bejn 0.3 sa 9.5 snin).
Danish: De medlemsstater, der gjorde indsigelse, anså ikke data fra den undersøgelse, som Novo Nordisk havde indsendt sammen med ansøgningen til støtte for den foreslåede indikation, for at være tilstrækkelige (en åben, ikke kontrolleret, retrospektiv undersøgelse) eller af god kvalitet (stor spredning i den anvendte dosis, ufuldstændige højdemålinger).
Maltese: Id-dejta mill-istudju li ġiet sottomessa mal-applikazzjoni ta' Novo Nordisk biex tappoġġa lindikazzjoni proposta ma tqiesitx suffiċjenti (studju b'tikketta miftuħa, mhux ikkontrollat u retrospettiv) u ta' kwalità tajba (firxa wiesgħa ta' dożi użati, kejl tat-tul mhux komplut) mill-Istati Membri li oġġezzjonaw.
Danish: 153 43 Aghia Paraskevi, Athen
Maltese: 153 43 Aghia Paraskevi, Athens
Danish: D-55127 Mainz Tyskland
Maltese: D-55127 Mainz
Danish: Quinta da Fonte - Edifício D. José - Piso 1, 2780-730 Paço d' Arcos
Maltese: Quinta da Fonte - Edifício D. José - Piso 1, 2780730
Danish: Novo Nordisk, Coeur Défense - 100, avenue du Général de Gaulle - 92400 Courbevoie Frankrig
Maltese: Novo Nordisk, Coeur Défense - 100, avenue du Général de Gaulle92400 Courbevoie Franza
Danish: Storbritannien Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, West Sussex RH11
Maltese: Ir-Renju Unit Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, West Sussex RH11 9RT
Danish: Luxembourg Novo Nordisk Pharma Riverside Business Park B-1070 Bruxelles
Maltese: Novo Nordisk Pharma Riverside Business Park B-1070 Bruxelles Il-Belġju
Danish: Flemingweg 18, 2408 AV ALPHEN A/D RIJN
Maltese: Flemingweg 18, 2408 AV ALPHEN A/D RIJN L-Olanda soluzzjoni għallinjezzjoni (oplossing voor injectie )
Danish: Grækenland Novo Nordisk Hellas Ltd. A. Panagouli 80 & Aghias Triados 65.
Maltese: Panagouli 80 & Aghias Triados 65.
Danish: Novo Nordisk - Comércio de Produtos Farmacêuticos, Lda.
Maltese: Novo Nordisk - Comércio de Produtos
Danish: Rumænien Novo Nordisk A/S Novo Allé
Maltese: Il-Polonja Novo Nordisk A/S Novo Allé
Danish: Novo Nordisk Pharma GmbH Brucknerstr.
Maltese: Il-Ġermanja Novo Nordisk Pharma GmbH
Danish: Production and Trading Medicines Averof 19A, Athens, 10433 Grækenland
Maltese: Production and Trading Medicines Averof 19A, Athens, 10433 Greece
Danish: Medborgarplatsen 25 118 72 Stockholm Sverige
Maltese: Medborgarplatsen 25 118 72 Stockholm Sweden
Danish: AstraZeneca AB 151 85 Södertälje Sverige
Maltese: AstraZeneca AB 151 85 Södertälje Sweden
Danish: London W5 5TL, Storbritannien
Maltese: London W5 5TL, United Kingdom
Danish: Benefit/risk
Maltese: Relazzjoni benefiċċju/riskju
Danish: Alternova AB Vallgatan 11 170 67 Solna Sverige
Maltese: Alternova AB Vallgatan 11 170 67 Solna Sweden
Danish: 170 09 Solna Sverige
Maltese: 170 09 Solna Sweden
Danish: Specifar Abee 28th October Street No 1 Agia Barbara 12351 Grækenland
Maltese: Specifar Abee 28th October Street No 1 Agia Barbara 12351 Greece
Danish: D-53125 Bonn Tyskland
Maltese: D-53125 Bonn Germany
Danish: Av. Tomás Ribeiro, 43 - Bloco 2, 3º FEdifício Neopark
Maltese: Tomás Ribeiro, 43 - Bloco 2, 3º FEdifício Neopark
Danish: Via Mario Lalli, 8 - 56127 Pisa Italien
Maltese: Via Mario Lalli, 8 - 56127 Pisa Italy
Danish: D-01309 Dresden Tyskland
Maltese: D-01309 Dresden Germany
Danish: Viale Città d'Europa 681 - 00144 Roma Italien
Maltese: Viale Città d'Europa 681 - 00144
Danish: 6 Km Markopoulo-Koropi Avenue Markopoulo Mesogeion 19003 Grækenland
Maltese: Km Markopoulo-Koropi Avenue Markopoulo Mesogeion 19003 Greece
Danish: Laboratoire RPG 4 place Louis Armand 75012 Paris Frankrig
Maltese: Laboratoire RPG 4 place Louis Armand 75012 Paris France
Danish: House, 97/107 Uxbridge Road, Ealing
Maltese: C.P. House, 97/107 Uxbridge Road, Ealing
Danish: Via dei Castelli Romani 22 - 00040 Pomezia (RM) Italien
Maltese: Via dei Castelli Romani 22 - 00040 Pomezia (RM) Italy
Danish: Via Pavia 6, 20131 Milano Italien
Maltese: Via Pavia 6, 20131 Milano Italy
Danish: AC Helcor Hungary Kft 1131 Budapest, Madarász Viktor u.27 Ungarn
Maltese: AC Helcor Hungary Kft 1131 Budapest, Madarász Viktor u.27 Hungary
Danish: Ratiopharm Belgium S.A Rue St-Lambert 141 1200 Bruxelles Belgien
Maltese: Ratiopharm Belgium S.A Rue St-Lambert 141 1200 Bruxelles Belgium
Danish: D-61118 Bad Vilbel Tyskland
Maltese: D-61118 Bad Vilbel Germany
Danish: Docpharma N.V Ambachtenlaan 13H 3001 Heverlee Belgien
Maltese: Docpharma N.V Ambachtenlaan 13H 3001 Heverlee Belgium
Danish: Alacan S.A Capricornio, 5, 03006 Alicante, Spanien
Maltese: Alacan S.A Capricornio, 5, 03006 Alicante, Spain
Danish: Actavis Italy SpA V.Jose'Escrivia De Balaguer, 6 21047 Saronno (VA) Italien
Maltese: Actavis Italy SpA V.Jose'Escrivia De Balaguer, 6 21047 Saronno (VA) Italy
Danish: Old Post House, Hithrow Road, Webbger Bridge, Surrey KT 138TS Storbritannien
Maltese: Old Post House, Hithrow Road, Webbger Bridge, Surrey KT 138TS United Kingdom
Danish: Stada Arzneimittel Stadastrasse 2-18 DE-61118 Bad Vilbel Tyskland
Maltese: Stada Arzneimittel Stadastrasse 2-18 DE-61118 Bad Vilbel Germany
Danish: Vianex S.A Tatoiou Street Nea Erythrea 14671 Grækenland
Maltese: Vianex S.A Tatoiou Street Nea Erythrea 14671 Greece
Danish: 15 Bd Charles de Gaulle 92700 Colombes Frankrig
Maltese: Bd Charles de Gaulle 92700 Colombes France
Danish: 49, avenue Georges Pompidou 92300 Levallois-Perret Frankrig
Maltese: 49, avenue Georges Pompidou 92300 Levallois-Perret France
Danish: Socobom N.V Louizalaan 149 B24 1050 Brussel Belgien
Maltese: Socobom N.V Louizalaan 149 B24 1050 Brussel Belgium
Danish: Magyarország Kereskedelmi Kft 1036 Budapest,
Maltese: Kft 1036 Budapest,
Danish: Bialfar - Produtos Farmacêuticos, S.A., Av. da Siderurgia Nacional, P.O. Box 56 4745-457 S. Mamede do Coronado,
Maltese: Bialfar - Produtos Farmacêuticos, S.A., Av. da Siderurgia Nacional, P.O. Box 56 4745-457 S.
Danish: Almirall Prodesfarma S.A Ronda General Mitre, 151, 08022 Barcelona, Spanien
Maltese: Almirall Prodesfarma S.A Ronda General Mitre, 151, 08022 Barcelona, Spain
Danish: Merck Generics BV, Dieselweg 25, 3752 LB Bunschoten, Holland
Maltese: Merck Generics BV, Dieselweg 25, 3752 LB Bunschoten, The Netherlands
Danish: D-82041 Oberhaching Tyskland
Maltese: D-82041 Oberhaching Germany
Danish: Arrow Generiques 26 av Tony Garnier 69007 Lyon Frankrig
Maltese: Arrow Generiques 26 av Tony Garnier 69007 Lyon France
Danish: Pabianickie Zakłady Farmaceutyczne Polfa S.A., ul.Marszałka J. Piłsudskiego 5
Maltese: Pabianickie Zakłady Farmaceutyczne Polfa S.A., ul.Marszałka J.
Danish: 92517 Boulogne Billancourt Cedex Frankrig
Maltese: 92517 Boulogne Billancourt Cedex France
Danish: Via A. Fleming 2 - 37135 Verona Italien
Maltese: Fleming 2 - 37135 Verona Italy
Danish: Sandoz B.V., Veluwezoom 22, 1327 AH Almere, Holland
Maltese: Sandoz B.V., Veluwezoom 22, 1327 AH Almere, The Netherlands
Danish: Merck Sharp & Dohme BV, Waarderweg 39, NL-2031 BN Haarlem, Holland
Maltese: Merck Sharp & Dohme BV, Waarderweg 39, NL-2031 BN Haarlem, The Netherlands
Danish: Biosarto, S.A Foc, 68-82, 08038 Barcelona, Spanien
Maltese: Biosarto, S.A Foc, 68-82, 08038 Barcelona, Spain
Danish: D-40789 Monheim Tyskland
Maltese: D-40789 Monheim Germany
Danish: Ratiopharm Oy, Vitikka 1 F, P.O Box 67, 02630 Espoo, Finland
Maltese: Ratiopharm Oy, Vitikka 1 F, P.O Box 67, 02630
Danish: Ranbaxy (UK) Ltd., 20 Balderton Street, London W1K6TL Storbritannien
Maltese: Ranbaxy (UK) Ltd., 20 Balderton Street, London W1K6TL United Kingdom
Danish: Quimifar, S.A Comadran, 37, 08210 Barbera del Valles, Spanien
Maltese: Quimifar, S.A Comadran, 37, 08210 Barbera del Valles, Spain
Danish: Sharp & Dohme, S.A Josefa Valcárcel, 38 28027 Madrid Spanien
Maltese: Sharp & Dohme, S.A Josefa Valcárcel, 38 28027 Madrid Spain
Danish: Juan XXIII, 15 - 19, 3ª planta, Esplugas de Llobregat, 08950 Spanien
Maltese: Juan XXIII, 15 - 19, 3ª planta, Esplugas de Llobregat, 08950 Spain
Danish: 1, cours du Triangle 92936 Paris la Défense Cedex Frankrig
Maltese: 1, cours du Triangle 92936 Paris la Défense Cedex France
Danish: Merck, Sharp et Dohme Chaussée de Waterloo 1135, 1180 Bruxelles Belgien
Maltese: Merck, Sharp et Dohme Chaussée de Waterloo 1135, 1180 Bruxelles Belgium
Danish: 92936 Paris la Défense cedex Frankrig
Maltese: 92936 Paris la Défense cedex France
Danish: 8501 Novo mesto Slovenien
Maltese: 8501 Novo mesto Slovenia
Danish: Ud fra følgende betragtninger:
Maltese: Sede legale:
Danish: Francia Farmaceutici Industria Farmaco Biologica Srl Via dei Pestagalli 7
Maltese: Industria Farmaco Biologica Srl Via dei Pestagalli 7
Danish: Laboratoire Qualimed 34, rue Saint-Romain 69008 Lyon Frankrig
Maltese: Laboratoire Qualimed 34, rue Saint-Romain 69008 Lyon France
Danish: S.C AC Helcor S.R.L Str. Victor Babes nr.50, Baia Mare, Jud Maramures, zip code; 430092
Maltese: Victor Babes nr.50, Baia Mare, Jud Maramures, zip code; 430092
Danish: Merck Generiques 34, rue Saint-Romain 69359 Lyon Cedex 08 Frankrig
Maltese: Merck Generiques 34, rue Saint-Romain 69359 Lyon Cedex 08 France
Danish: Ratiopharm Hungária Kft. 1145 Budapest Uzsoki u. 36/a Ungarn
Maltese: Ratiopharm Hungária Kft. 1145 Budapest Uzsoki u.
Danish: S.C Terapia S.A Str. Fabricii nr. 124, Zip code : 400640 Cluj Napoca, Rumænien
Maltese: Fabricii nr. 124, Zip code : 400640 Cluj Napoca, România
Danish: Cypern
Maltese: Cyprus
Danish: Sanofi Aventis France 1/13, Bd Romain Rolland 75014 Paris
Maltese: France 1/13, Bd Romain Rolland 75014
Danish: Francia Farmaceutici Industria Farmaco Biologica SrlVia dei Pestagalli 7
Maltese: Industria Farmaco Biologica SrlVia dei Pestagalli 7
Danish: Via G. Fabbroni, 6 - 00191 Roma Italien
Maltese: Fabbroni, 6 - 00191 Roma Italy
Danish: Pliva Pharma S.p.A via Tranquillo Cremona, 10 - 20092 Cinisello Balsamo (MI) Italien
Maltese: Pliva Pharma S.p.A via Tranquillo Cremona, 10 - 20092 Cinisello Balsamo (MI) Italy
Danish: Ratiopharm Nederland BV, Ronde Tocht 11, 1507 CC Zaandam, Holland
Maltese: Ratiopharm Nederland BV, Ronde Tocht 11, 1507 CC
Danish: Remedica Ltd, P.O Box 51706 Lemesos Cypern
Maltese: Remedica Ltd, P.O Box 51706 Lemesos Cyprus
Danish: Avgis & Gallinis 15, N. Kifissia Grækenland
Maltese: Avgis & Gallinis 15, N.
Danish: Ranbaxy (UK) Ltd. C.P.
Maltese: Ranbaxy (UK) Ltd.
Danish: Korinthou 12, N. Psychiko, 15451 Grækenland
Maltese: Psychiko, 15451 Greece
Danish: Nieuwe Donk 9, 4879 AC Etten-Leur, Holland
Maltese: Centrafarm Services B.V. Nieuwe Donk 9, 4879 AC Etten-Leur, The Netherlands
Danish: Eurogenerics Heizel Esplanade B22 1020 Brussel Belgien
Maltese: Eurogenerics Heizel Esplanade B22 1020
Danish: Merck Sharp - Dohme Chibret 3 avenue Hoche 75114 Paris Cedex 08
Maltese: Merck Sharp - Dohme Chibret 3 avenue Hoche 75114
Danish: Vilco S.A Pefkon Street 121 N. Irakleion 14122 Grækenland
Maltese: Vilco S.A Pefkon Street 121 N.
Danish: I-27010 Valle Salimbene (PV) Itaien
Maltese: Valle Salimbene (PV) Italy
Danish: Ozone Laboratories Ltd, 38 Princes Court, 88 Brompton Road, Knightsbridge, SW3 1ES London Storbritannien
Maltese: Ozone Laboratories Ltd, 38 Princes Court, 88 Brompton Road, Knightsbridge, SW3 1ES London United Kingdom
Danish: Ozone Laboratories Ltd, 38 Princes Court 88 Brompton Road, Knightsbridge, SW3 1ES London Storbritannien
Maltese: Ozone Laboratories Ltd, 38 Princes Court 88 Brompton Road, Knightsbridge, SW3 1ES London United Kingdom
Danish: D-83607 Holzkirchen Tyskland
Maltese: D-83607 Holzkirchen Germany
Danish: So. Se.
Maltese: Se.
Danish: Largo Umberto Boccioni, 1 21040 - Origgio (VA) Italien
Maltese: Largo Umberto Boccioni, 1 21040
Danish: Sede legale: ABC Farmaceutici S.p.A.
Maltese: ABC Farmaceutici S.p.A.
Danish: Medochemie Ltd, P.O Box 51409 Lemesos Cypern
Maltese: Medochemie Ltd, P.O Box 51409 Lemesos
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,
Maltese: • Il-Kumitat ikkunsidra r-referenza magħmula skont l-Artiklu 31 tad-Direttiva 2001/83/KE, kif emendata, għall-prodotti mediċinali li fihom norfloxacin;
Danish: S.C Labormed-Pharma S.A Splaiul Independentei nr. 319E, sector 6, Bucharest, zip code: 060044
Maltese: 319E, sector 6, Bucharest, zip code: 060044
Danish: Krka, d.d., Novo mesto Šmarješka cesta 6
Maltese: Ir-Repubblika Ċeka Krka, d.d., Novo mesto Šmarješka cesta 6
Danish: Gyrablock 400 mg 400 mg
Maltese: Gyrablock 400 mg
Danish: 100ml contains 5,4g of Norfloxacin pivaloil-oxymethyl-ester as 4,0g of Norfloxacin
Maltese: 100ml fih 5.4g ta' Norfloxacin pivaloil-oxymethyl-ester bħala 4.0g ta' Norfloxacin
Danish: K Paleologou & Perikleous 153 32 Halandri Athens
Maltese: Anfarm Hellas S.A. K Paleologou & Perikleous 153 32 Halandri Athens
Danish: Samlet set omfattede de indkomne svar vedlagte bibliografiske data og et forslag om opdatering af produktresuméets afsnit 5.1.
Maltese: Globalment, it-tweġibiet ipprovduti inkludew dejta bibljografika u proposta għall-aġġornament tas-sezzjoni 5.1 talSPC.
Danish: Norflox-1A Pharma 400 mg
Maltese: Norflox-1A Pharma
Danish: Ratiopharm GmbH Graf Arco Strasse 3 89079 Ulm Tyskland
Maltese: Ratiopharm GmbH Graf Arco Strasse 3 89079 Ulm Germany
Danish: Ruhrpharm AG Heidsieker Heide 114 D-33739 Bielefeld Germany
Maltese: Ruhrpharm AG Heidsieker Heide 114
Danish: Ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Tyskland
Maltese: Ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany
Danish: Henvisningsproceduren blev dernæst påbegyndt den 20. september 2007.
Maltese: Il-proċedura ta' referenza nbdiet fl-20 ta' Settembru 2007.
Danish: via Tranquillo Cremona, 10 - 20092 Cinisello Balsamo (MI) Italien
Maltese: Pliva Pharma S.p.A. via Tranquillo Cremona, 10 - 20092 Cinisello Balsamo (MI) Italy
Danish: Smarješka cesta 6, Sl-8501 Novo mesto Slovenien
Maltese: Smarješka cesta 6, Sl-8501 Novo mesto Slovenia
Danish: via Felice Casati, 16 - 20124 Milano Italien
Maltese: Tad Pharma Italia S.r.l. via Felice Casati, 16 - 20124
Danish: CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin Tyskland
Maltese: 42 a D-13407 Berlin Germany
Danish: Merck, Sharp & Dohme GmbH Donau - City - Straße 6 A-1220 Wien
Maltese: Merck, Sharp & Dohme GmbH Donau - City - Straße 6
Danish: Krka d.d Novo Mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenien
Maltese: Krka d.d Novo Mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia
Danish: 540mg of Norfloxacin pivaloil-oxymethyl-ester as 400mg of Norfloxacin
Maltese: 540mg ta' Norfloxacin pivaloil-oxymethyl-ester bħala 400mg ta' Norfloxacin
Danish: Eurogenerics Esplanade Heysel, B.22 B-1020 Bruxelles Belgien
Maltese: Il-Lussemburgu Eurogenerics Esplanade Heysel, B.22
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.
Maltese: Madankollu s-CHMP laqa' l-idea li jiġu aġġornati l-breakpoints tal-MIC fis-sezzjoni 5.1 tal-SPC biex jinkludu l-breakpoints tal-MIC kif definiti mill-Kumitat Ewropew għall-Ittestjar tas-Suxxettibilità Antimikrobika (EUCAST) fis-sezzjoni 5.1 tal-SPC għax dawn il-breakpoints mhumiex relatati biss mal-patoġeni preżenti fil-pjelonefrite kumplikata, iżda wkoll ma' patoġeni komuni tal-apparat urinarju preżenti f'indikazzjonijiet urinarji oħra.
Danish: BEGRUNDELSER FOR FJERNELSE AF DEN TERAPEUTISKE INDIKATION "AKUT OG KRONISK KOMPLICERET PYELONEFRITIS"
Maltese: GĦAT-TNEĦĦIJA TAL-INDIKAZZJONI TERAPEWTIKA "PJELONEFRITE AKUTA U KRONIKA KUMPLIKATA"
Danish: Floxolone 400mg 400 mg
Maltese: Floxolone 400mg
Danish: Šmarješka cesta 6 8501 Novo mesto Slovenien
Maltese: Šmarješka cesta 6 8501 Novo mesto Slovenia
Danish: Sandoz GmbH Biochemiestrasse 10 AT-6250 Kundl Østrig
Maltese: Sandoz GmbH Biochemiestrasse 10 AT-6250 Kundl Austria
Danish: TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, Cuxhaven, D-27472
Maltese: TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, Cuxhaven, D-27472 Germany
Danish: Medochemie Ltd, Limassol Constantinoupoleos St. 1-10, P.O.Box 51409, CY-3505 Limassol Cypern
Maltese: St. 1-10, P.O.Box 51409, CY-3505 Limassol Cyprus
Danish: Aliud Pharma GmbH & Co.KG Gottlieb-Daimler-Str. 19
Maltese: Aliud Pharma GmbH & Co.KG Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Danish: Overtrukket tablet
Maltese: Uroctal Comprimidos
Danish: Sandoz Farmaceutica, S.A Avenida de Osa Mayor 4.
Maltese: Sandoz Farmaceutica, S.A Avenida de Osa Mayor 4. 28023 Aravaca Madrid
Danish: Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenien
Maltese: Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Danish: • CHMP konkluderede følgelig, at benefit/risk-forholdet for perorale lægemidler, der indeholder norfloxacin, er negativt ved ovennævnte indikation.
Maltese: • Il-Kumitat, għaldaqstant, ikkonkluda li r-relazzjoni bejn il-benefiċċju u r-riskju ta' prodotti mediċinali orali li fihom norfloxacin huwa negattiv fl-indikazzjoni msemmija hawn fuq.
Danish: Tad Pharma GmbH, Heinz-Lohmann-Strasse 5 27472 Cuxhaven Tyskland
Maltese: Tad Pharma GmbH, Heinz-Lohmann-Strasse 5 27472 Cuxhaven Germany
Danish: Tad Pharma GmbH Heinz-Lohmann Strasse 5, DE-27472, Cuxhaven Tyskland
Maltese: Tad Pharma GmbH Heinz-Lohmann Strasse 5, DE-27472, Cuxhaven Germany
Danish: anbefaler CHMP fjernelse af den terapeutiske indikation "akut og kronisk kompliceret pyelonefritis" for lægemidler, der indeholder norfloxacin, og som tages oralt (se listen over lægemidler i
Maltese: Is-CHMP irrakkomanda t-tneħħija tal-indikazzjoni terapewtika "pjelonefrite akuta jew kronika kumplikata" għall-prodotti mediċinali li fihom norfloxacin meħudin oralment (b'referenza għallprodotti mediċinali elenkati fl-Anness I).
Danish: Indehaverne af markedsføringstilladelse fremlagde ingen relevante oplysninger, der kunne give en sammenligning af vævskoncentrationerne efter peroral behandling med norfloxacin, ciprofloxacin, ofloxacin og levofloxacin.
Maltese: Il-MAHs ma pprovdew l-ebda tagħrif rilevanti li juri l-paragun tal-konċentrazzjonijiet fit-tessuti wara t-trattament orali b'norfloxacin, ciprofloxacin, ofloxacin u levofloxacin.
Danish: Procter & Gamble Pharmaceuticals France 163-165 Quai Aulagnier 92600 Asnières-sur-Seine Frankrig
Maltese: Procter & Gamble Pharmaceuticals France 163-165 Quai Aulagnier 92600 Asnières-sur-Seine Franza
Danish: 64331 Weiterstadt Tyskland
Maltese: 64331 Weiterstadt Il-Ġermanja
Danish: Viale Luigi Bodio, 37/b 20158 Milano Italien
Maltese: Viale Luigi Bodio, 37/b 20158 Milano L-Italja
Danish: Sverige sanofi-aventis S.p.A.
Maltese: L-Isvezja sanofi-aventis S.p.A.
Danish: Ansøgeren fremsendte en ansøgning om gensidig anerkendelse af den markedsføringstilladelse, som Sverige udstedte i 2006 for Norsed Combi D, som er et kombinationslægemiddel, der består af risedronatnatrium 35 mg filmovertrukne tabletter sammen med 1000 mg calciumcarbonat og 880 IE colecalciferol brusegranulat.
Maltese: L-Applikant issottometta applikazzjoni għal rikonoxximent reċiproku talawtorizzazzjoni għat-tqegħid fis-suq mogħtija mill-Isvezja fl-2006 għal Norsed Combi D, prodott ta' kombinazzjoni magħmul minn pilloli ta' 35 mg risedronate sodium miksijin b'rita flimkien ma' 1000 mg karbonat tal-kalċju u 880 IU granuli effervexxenti ta' colecalciferol.
Danish: viale Luigi Bodio, 37/B 20158 Milan Italien
Maltese: L-Italja sanofi-aventis S.p.A. viale Luigi Bodio, 37/B 20158 Milan L-Italja
Danish: Medlemsstat Indehaver af markedsføringstil ladelse
Maltese: Stat Membru Id-Detentur ta' lAwtorizzazzjoni għat-tqegħid fis-Suq
Danish: Brev(PE/alu/PET)
Maltese: Qartas (PE/alu/PET)
Danish: 100 mg Pulver til oral suspension
Maltese: 100 mg Trab għal suspensjoni orali
Danish: 30 breve + 2 sprøjter + 1blandekop
Maltese: 30 qratas + 2 siringi + 1 tazza tat-taħlit
Danish: Oral use
Maltese: Użu orali
Danish: Administration Emballage Indhold (Koncentration)
Maltese: Kontenut (konċentrazzjoni)
Danish: ~3 til 5
Maltese: ~3 to 5
Danish: Hypromellose Titandioxid (E171) Macrogoler
Maltese: Hypromellose Titanium dioxide (E171) Macrogols
Danish: Cl/F (l/t)
Maltese: Cl/F (L/h)
Danish: Delavirdin1 ↔ ↔
Maltese: Delavirdine1 ↔ ↔
Danish: Didanosin ↓ 13 % ↔
Maltese: Didanosine ↓ 13% ↔
Danish: Ciclosporin, tacrolimus, everolimus
Maltese: Cyclosporine, tacrolimus, everolimus
Danish: Amlodipin, diltiazem, nifedipin
Maltese: Amlodipine, diltiazem, nifedipine
Danish: Erythromycin, itraconazol
Maltese: Erythromycin, itraconazole
Danish: Rifabutin1 25-O-desacetyl-rifabutin metabolit
Maltese: Rifabutin1 Metabolat 25-O-desacetyl rifabutin
Danish: ATC kode: J05A E03.
Maltese: J05A E03
Danish: Clozapin, pimozid
Maltese: Clozapine, pimozide
Danish: maraviroc, raltegravir, zidovudin);
Maltese: maraviroc, raltegravir, zidovudine);
Danish: Theophyllin1
Maltese: Theophylline1
Danish: Dosis af Norvir (mg)
Maltese: Doża ta' NORVIR (mg)
Danish: Clarithromycin 14-OH-clarithromycin metabolit
Maltese: Metabolat 14-OH clarithromycin
Danish: Methadon1
Maltese: Methadone1
Danish: Kliniske farmakodynamiske data
Maltese: Informazzjoni klinika farmakodinamika
Danish: Stevens-Johnsons syndrom, toksisk epidermal nekrolyse (TEN)
Maltese: Sindromu Stevens Johnson, Nekroliżi tossika tal-epidermide (TEN)
Danish: Sulfamethoxazol+Trimethoprim2
Maltese: Sulfamethoxazole/Trimethoprim2
Danish: Hydroxypropylcellulose Talcum
Maltese: Hydroxypropyl cellulose Talc
Danish: Kolloid silica, vandfri Polysorbat 80
Maltese: Silica, colloidal anyhdrous Polysorbate 80
Danish: Beta2-agonister (langtidsvirkende)
Maltese: β2-agonist (iħalli effett fit-tul)
Danish: Haloperidol, risperidon, thioridazin
Maltese: Haloperidol, risperidone, thioridazine
Danish: Zuiderzeelaan 53, 8017 JV Zwolle, Holland
Maltese: AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, The Netherlands
Danish: Bupropion metaboliseres hovedsagelig af CYP2B6.
Maltese: Bupropion huwa primarjament metabolizzat b' CYP2B6.
Danish: Pethidin, piroxicam, propoxyphen
Maltese: Pethidine, piroxicam, propoxyphne
Danish: AUC og Cmax af 2-hydroxymetabolitten blev nedsat med henholdsvis 15 og 67 %.
Maltese: L-AUC u Cmax tal-metabolat 2-hydroxy ġew imnaqqsa b' 15 u 67%,
Danish: Riv brevet op (se figur 3).
Maltese: Qatta u iftaħ l-qartas (ara Figura 3).
Danish: Norvir 100 mg tabletter
Maltese: Norvir 100 mg pillola
Danish: • resultater af laboratorietest:
Maltese: • riżultati tat-testijiet tal-laboratorju:
Danish: Pankreatit
Maltese: Pankreatite
Danish: ↑ 152 % ND
Maltese: Nelfinavir ↑ 152%
Danish: PDE5-hæmmer
Maltese: Impedituri PDE5
Danish: Amitriptylin, fluoxetin, imipramin, nortriptylin, paroxetin, sertralin
Maltese: Amitriptyline, fluoxetine, imipramine, nortriptyline, paroxetine, sertraline
Danish: Dasatinib, nilotinib, vincristin, vinblastin
Maltese: Dasatinib, nilotinib, vincristine, vinblastine
Danish: Astemizol, terfenadin Forhøjede plasmakoncentrationer af astemizol og terfanadin.
Maltese: Astemizole, terfenadine Żieda fil-konċentrazzjoni fil-plażma ta' astemizole u terfenadine.