FrancophonIA/ELRC3.0 huggingface dataset:
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Fluenz Tetra den 4. december 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Fluenz Tetra valida fl-Unjoni Ewropea kollha fl-4 ta' Diċembru 2013.
Danish: Fluenz Tetra leveres som næsespray.
Maltese: Fluenz Tetra jiġi bħala sprej nażali.
Danish: Hvorfor er Fluenz Tetra blevet godkendt?
Maltese: Għal xiex ġie approvat Fluenz Tetra?
Danish: Fluenz Tetra indeholder begge influenza B-virus og giver derfor bredere beskyttelse mod influenza B.
Maltese: L-inkużjoni taż-żewġ virusis talinfluwenza B fi Fluenz Tetra tista' tipprovdi protezzjoni akbar kontra l-influwenza B.
Danish: Den må heller ikke anvendes til børn med svækket immunforsvar som følge af sygdomme såsom blodsygdomme, symptomgivende hivinfektion, kræft eller visse medicinske behandlinger, eller til børn, som behandles med salicylater (smertestillende midler såsom acetylsalicylsyre).
Maltese: Lanqas m'għandu jingħata lil tfal b'sistema immunitarja mdgħajfa minħabba kondizzjonijiet bħal disturbi fid-demm, infezzjoni HIV sintomatika, kanċer jew ċerti kuri mediċi, u lanqas lit-tfal li qegħdin jirċievu kura b'saliċilati (analġesiċi bħall-aspirina).
Danish: Sikkerhedsprofilen af Fluenz Tetra svarer til Fluenz og blev anset for acceptabel.
Maltese: Il-profil ta' sigurtà ta' Fluenz Tetra huwa simili għal Fluenz u kien ikkunsidrat aċċettabbli.
Danish: Fluenz Tetra influenzavaccine (levende svækket, nasal)
Maltese: Fluenz Tetra vaċċin kontra l-influwenza (ħaj attenwat, nażali)
Danish: de Europa 20 B 28108 Alcobendas SPAIN
Maltese: Avda. de Europa 20 B 28108 Alcobendas SPAIN
Danish: Medlemsstat /EØS
Maltese: Stat Membru/EEA
Danish: Rumænien Dar al Dawa Veterinary & Agricultural Industrial Co.
Maltese: Ir-Rumanija Dar al Dawa Veterinary & Agricultural Industrial Co.
Danish: Grækenland Agroseed-Candilidis Parapleuros Attikis Road Exodos 1,Thesi Xiro Pigadi 19600 Mandra Attikis GREECE
Maltese: Il-Greċja Agroseed-Candilidis Parapleuros Attikis Road Exodos 1,Thesi Xiro Pigadi 19600 Mandra Attikis GREECE
Danish: Ceva Saúde AnimalProdutos Farmacêuticos e Imunológicos, Lda.
Maltese: Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda.
Danish: Rumænien CEVASA Cervantes 1543/45
Maltese: Ir-Rumanija CEVASA Cervantes 1543/45
Danish: Vetrepharm A/S Øgelundvej 7
Maltese: Id-Danimarka Vetrepharm A/S Øgelundvej 7
Danish: Gruppe 4.
Maltese: Grupp 1.
Danish: Gruppe
Maltese: Grupp
Danish: 20-616 Lublin POLAND
Maltese: 20-616 Lublin
Danish: Dunavet-B Zrt.
Maltese: L-Ungerija Dunavet-B Zrt.
Danish: Rumænien Golashpharma Ltd. 33, Pobeda Str.
Maltese: Ir-Rumanija Golashpharma Ltd. 33, Pobeda Str.
Danish: 4400 Nyíregyháza HUNGARY
Maltese: 4400 Nyíregyháza
Danish: 2600-135 Vila Franca de Xira (Vialonga) PORTUGAL
Maltese: 2600-135 Vila Franca de Xira (Vialonga)
Danish: 05-651 Drwalew POLAND
Maltese: 05-651 Drwalew
Danish: Grækenland New Vet Hellas AE Fleming 15
Maltese: Il-Greċja New Vet Hellas AE Fleming 15
Danish: Rumænien Ceva Santé Animale Romania SRL
Maltese: Ir-Rumanija Ceva Santé Animale Romania SRL
Danish: 4002 Stavanger NORWAY
Maltese: 4002 Stavanger
Danish: Grækenland Tetoros Bros ABE 10 Km National road Athens-Lamia
Maltese: Il-Greċja Tetoros Bros ABE 10 Km National road AthensLamia
Danish: Przedsiębiorstwo Wielobranżowe "Vet Agro" Sp. zo.o.
Maltese: Il-Polonja Przedsiębiorstwo Wielobranżowe "Vet Agro" Sp. zo.o.
Danish: 08520 Les Franqueses del Valles
Maltese: 08520 Les Franqueses del Valles SPAIN
Danish: Rumænien Pharmateka BT Szíjgyártó str. 10
Maltese: Ir-Rumanija Pharmateka BT Szíjgyártó str. 10
Danish: 20 59439 Holzwickede GERMANY
Maltese: 59439 Holzwickede
Danish: 2821 Gyermely HUNGARY
Maltese: 2821 Gyermely
Danish: Grækenland VETHELLAS 31 Augoustou 51
Maltese: Il-Greċja VETHELLAS 31 Augoustou 51
Danish: 00330 Helsinki FINLAND
Maltese: 00330 Helsinki
Danish: 41221 Larissa
Maltese: 41221 Larissa GREECE
Danish: 88212 Ravensburg GERMANY
Maltese: 88212 Ravensburg
Danish: 10 rue Clement Ader ZA le Patis 78120 Rambouillet FRANCE
Maltese: 10 rue Clement Ader ZA le Patis 78120
Danish: Av. Baix Llobregat, 3-5 08970 Sant Joan Despi (Barcelona) SPAIN
Maltese: Baix Llobregat, 3-5 08970 Sant Joan Despi (Barcelona)
Danish: 53022 Laval Cedex 9 FRANCE
Maltese: 53022 Laval Cedex 9
Danish: Albrecht GmbH Hauptstr.
Maltese: Il-Ġermanja Albrecht GmbH Hauptstr.
Danish: Medicineret foder
Maltese: Medicated feed
Danish: 08228 Tarrasa SPAIN
Maltese: 08228 Tarrasa
Danish: Rumænien Orion Corporation Orionintie 1A
Maltese: Ir-Rumanija Orion Corporation Orionintie 1A
Danish: T. Skretting A/S P.O. Box 319
Maltese: In-Norveġja T. Skretting A/S P.O. Box 319
Danish: Oral pasta
Maltese: Oral paste
Danish: 28031 Madrid SPAIN
Maltese: 28031 Madrid
Danish: Grækenland Pfizer Hellas SA Mesogeion Av 243
Maltese: Pfizer Hellas SA Mesogeion Av 243
Danish: 7323 Brande DENMARK
Maltese: 7323 Brande
Danish: VIRBAC ESPAÑA, S.A. Angel Guimera, 179-181 08950 Esplugues de Llobregat
Maltese: VIRBAC ESPAÑA, S.A. Angel Guimera, 179-181 08950 Esplugues de Llobregat SPAIN
Danish: Rumænien DELOS IMPEX' 96 SRL Str. Horia
Maltese: Ir-Rumanija DELOS IMPEX' 96 SRL Str.
Danish: Przedsiębiorstwo Farmaceutyczne Okoniewscy "VETOSFARMA" Sp. z o.o.
Maltese: Il-Polonja Przedsiębiorstwo Farmaceutyczne Okoniewscy "VETOS-FARMA" Sp. z o.o. ul.
Danish: Industrial Veterinaria S.A. Esmeralda, 19 - 4º 08950 Esplugues de Llobregat
Maltese: Industrial Veterinaria S.A. Esmeralda, 19 - 4º 08950 Esplugues de Llobregat SPAIN
Danish: Ceva Animal Health Ltd 90 The Broadway Chesham
Maltese: L-Irlanda Ceva Animal Health Ltd 90 The Broadway
Danish: Scan Vet Poland Sp. z o.o.
Maltese: Il-Polonja Scan Vet Poland Sp. z o.o. ul.
Danish: Animal Health Division Bayer House Strawberry Hill Newbury
Maltese: L-Irlanda Bayer plc Animal Health Division Bayer House Strawberry Hill Newbury
Danish: Norge
Maltese: NORWAY
Danish: 200, avenue de Mayenne B.P. 2227
Maltese: Zone Industrielle des Touches 200, avenue de Mayenne B.P. 2227
Danish: Bulgarien
Maltese: BULGARIA
Danish: Virbac S.A. via dei Gracchi, 30 20146 Milano (MI) ITALY
Maltese: Virbac S.A. via dei Gracchi, 30 20146
Danish: Pfizer Trading Polska Sp. z o.o.
Maltese: Il-Polonja Pfizer Trading Polska Sp. z o.o.
Danish: 228,4 mg/ml (svarende til 180 mg/ml Danofloxacin)
Maltese: 228.4 mg/ml (ekwivalenti għal 180 mg/ml Danofloxacin)
Danish: Colistinsulfat 12 g
Maltese: Colistine sulphate 12 g
Danish: Rumænien Pasteur - Filiala Filipesti Srl Str. Principala nr. 944
Maltese: Ir-Rumanija Pasteur - Filiala Filipesti Srl Str.
Danish: Difloxacinhydrochlorid
Maltese: Difloxacin hydrochloride
Danish: Vétoquinol S. A. Magny Vernois B.P. 189
Maltese: Magny Vernois B.P. 189
Danish: Vetoquinol UK Ltd Great Slade, Buckingham Industrial Estate Buckingham
Maltese: L-Irlanda Vetoquinol UK Ltd Great Slade, Buckingham Industrial Estate
Danish: Rzymowskiego 34 02-697 Warszawa POLAND
Maltese: 02-697 Warszawa
Danish: Andreotti Farmaceutical Srl Via Eridania Ovest 65 45030 Guarda Veneta (RO) ITALY
Maltese: Andreotti Farmaceutical Srl Via Eridania Ovest 65 45030
Danish: Flumeq 50-S 500 mg/g Powder for use in drinking water /milk for cattle and chicken
Maltese: Flumeq 50-S 500 mg/g Trab for use in drinking water /milk for cattle and chicken
Danish: VMD Állatgyógyászati Kft. Közraktár u. 22/b.
Maltese: Közraktár u. 22/b.
Danish: 1130 Brussels BELGIUM
Maltese: 1130 Brussels
Danish: Pfizer Oy, Animal Health Tietokuja 4
Maltese: Il-Finlandja Pfizer Oy, Animal Health Tietokuja 4
Danish: Oral suspension
Maltese: Sospensjoni orali
Danish: Koncentrat til oral opløsning
Maltese: Concentrate for Soluzzjoni orali
Danish: Praça Dr. Francisco Sá Carneiro, n.º 7-5º esquerdo 1000-159 Lisboa PORTUGAL
Maltese: IBERIL - Soc. Comercial de Produtos Agro-Pecuários, Lda Praça Dr. Francisco Sá Carneiro, n.º 7-5º esquerdo 1000-159 Lisboa PORTUGAL
Danish: Rumænien CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
Maltese: Ir-Rumanija CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
Danish: Hoge Mauw 900 2370 Arendonk BELGIUM
Maltese: 2370 Arendonk BELGIUM
Danish: 1 Ikke til decoquinat.
Maltese: 1 Mhux għal decoquinate.
Danish: Flumequin
Maltese: Flumequine
Danish: Pfizer GmbH Linkstr.
Maltese: Il-Ġermanja Pfizer GmbH Linkstr. 10
Danish: Pfizer Ltd Ramsgate Road Sandwich Kent
Maltese: Il-Bulgarija Pfizer Ltd Ramsgate Road Sandwich
Danish: 5531 BK Bladel NETHERLAND
Maltese: 5531 BK Bladel
Danish: Rumænien Veterina Ltd. Svetonedeljska 2, Kalinovica 10436 Rakov Potok CROATIA
Maltese: Svetonedeljska 2, Kalinovica 10436
Danish: Pr. g:
Maltese: Via G.
Danish: Euro-Quin 10 % Powder for Oral Solution
Maltese: Euro-Quin 10 % Trab for Oral Solution
Danish: Naquilene 500 MP
Maltese: Naquilene 500
Danish: 16, Via Don Eugenio Servadei
Maltese: 16, Via Don Eugenio Servadei 47100 Forli
Danish: Quinolonprodukter1 (f.eks. flumequin, oxolinsyre)
Maltese: Prodotti li fihom kwinoloni 1 (eż. flumequine, oxolinic acid)
Danish: Flumequine Durden Flumequin
Maltese: Flumequine Durden Flumequine
Danish: 08950 Esplugues de
Maltese: 08950 Esplugues de Llobregat SPAIN
Danish: 3 43206 Reus
Maltese: Reus-Cambrils, Km. 3 43206 Reus
Danish: Chanelle Pharmaceuticals Manufacturing Limited IDA Business & Technology Park
Maltese: Chanelle Pharmaceuticals Manufacturing Limited IDA Business & Technology Park Loughrea
Danish: 11,5 g/100 g Oralt pulver
Maltese: 11.5 g/100 g Trab orali
Danish: Calluna Pharma bvba Lindendreef 16 box 4 2320 Hoogstraten BELGIUM
Maltese: Il-Ġermanja Calluna Pharma bvba Lindendreef 16 box 4
Danish: Azienda Terapeutica Italiana A.T.I.
Maltese: Azienda Terapeutica Italiana A.T.I. S.P.A. via della Libertà 1
Danish: Industrial Area Aradippou 7100 P.O. Box 40261 6302 Larnaca
Maltese: Industrial Area Aradippou 7100 P.O. Box 40261
Danish: A. For lægemidler i bilag I indeholdende fluoroquinoloner (enrofloxacin, marbofloxacin, danofloxacin og difloxacin):
Maltese: Għall-prodotti elenkati fl-Anness I li fihom il-fluworokwinoloni (enrofloxacin, marbofloxacin, danofloxacin u difloxacin):
Danish: Bayer Austria GmbH Herbststraße 6-10 1160 Wien AUSTRIA
Maltese: L-Awstrija Bayer Austria GmbH Herbststraße 6-10
Danish: Polen
Maltese: POLAND
Danish: 100 mg/ml enrofloxacin 109 IE colistinsulfat
Maltese: 100 mg/ml enrofloxacin 109 IU colistin sulphate
Danish: Vétoquinol Verwaltungs GmbH
Maltese: Il-Ġermanja Vétoquinol Verwaltungs GmbH Parkstr. 10
Danish: Laboratorios Ovejero, S. A. Ctra.
Maltese: Laboratorios Ovejero, S. A.
Danish: Pr. ml: danofloxacinme sylat 31,73 mg svarende til danofloxacin 25 mg
Maltese: Danofloxacin mesilate per ml: danofloxacin mesylate 31,73 mg ekwivalenti għal danofloxacin 25 mg
Danish: Chinogel 50 Mix
Maltese: Chinogel 50
Danish: Fatro Uriach Veterinaria, S.L.
Maltese: Fatro Uriach Veterinaria, S.L. Constitucion, 1
Danish: Grækenland Virbac S.A. 1ere Avenue 2065 M LID B.P. 27
Maltese: Il-Greċja Virbac S.A. 1ere Avenue 2065 M LID B.P. 27
Danish: Rumænien Divasa-Farmavic S.A. Ctra San Hipolito km 71
Maltese: Ir-Rumanija Divasa-Farmavic S.A. Ctra San Hipolito km 71
Danish: Enrofloxacin Bromhexin
Maltese: Enrofloxacin Bromhexine
Danish: Industrial Area Aradippou 7100; P.O. Box 40261 6302 Larnaca
Maltese: Industrial Area Aradippou 7100; P.O. Box 40261
Danish: Naquilene 500 MP Premix For Medicated Feeding Stuff
Maltese: MP Premix For Medicated Feeding Stuff
Danish: Via Diaz 147/149
Maltese: Laboratorio Vaccinogeno Pagnini Via Diaz 147/149
Danish: 13 - piso 1 escritorio 3 Quinta da Beloura 2710-444 Sintra PORTUGAL
Maltese: Quinta da Beloura 2710-444
Danish: Drinkmix flumequine Flumequin
Maltese: Drinkmix flumequine Flumequine
Danish: Flumesyva Premezcla Flumequin
Maltese: Flumesyva Premezcla Flumequine
Danish: Gastroenteralt
Maltese: Gastroenteral
Danish: Kvæg Eksotiske dyr
Maltese: Exotic pet animals
Danish: Calier PortugalMedicamentos e Produtos Veterinários SA R Pé Mouro Edifício CLinhó
Maltese: Calier Portugal-Medicamentos e Produtos Veterinários SA R Pé Mouro Edifício C - Linhó 2710-335 Sintra PORTUGAL
Danish: Fluyesyva Inyectable Flumequin
Maltese: Fluyesyva Inyectable Flumequine
Danish: 100 g/1000 g Oralt pulver
Maltese: 100 g/1000 g Trab orali
Danish: Biovet AD 39 Petar Rakov Str. 4550 Peshtera BULGARIA
Maltese: Il-Bulgarija Biovet AD 39 Petar Rakov Str.
Danish: Bayer A/S Nørgaardsvej 32 Postboks 2090
Maltese: L-Iżlanda Bayer A/S Nørgaardsvej 32
Danish: Esteve Farma, Lda Av. Do Forte, 3 - Edifício Suécia II, Piso 4A 2794-044 Carnaxide PORTUGAL
Maltese: Do Forte, 3 - Edifício Suécia II, Piso 4A
Danish: Kontichsesteenweg 42 2630 Aartselaar BELGIUM
Maltese: 2630 Aartselaar BELGIUM
Danish: Grækenland Laboratoires Biové 3 Rue de Lorraine, BP 45
Maltese: Il-Greċja Laboratoires Biové 3 Rue de Lorraine, BP 45 62510
Danish: 1093 Budapest HUNGARY
Maltese: 1093 Budapest
Danish: 50 mg/ml enrofloxacin 500.000 IE/ml colistinsulfat
Maltese: 50 mg/ml enrofloxacin 500 000 IU/ml colistin sulphate
Danish: Nederlandene Eurovet Animal Health B.V.
Maltese: L-Olanda Eurovet Animal Health B.V. Handelsweg 25
Danish: S.P. Veterinaria S.A. Ctra.
Maltese: S.P. Veterinaria S.A.
Danish: ICC-O-Flu 50% Flumequin
Maltese: ICC-O-Flu 50% Flumequine
Danish: Rumænien Pfizer Animal Health Ramsgate Road
Maltese: Ir-Rumanija Pfizer Animal Health Ramsgate Road
Danish: Nederlandene Pfizer Animal Health B.V.
Maltese: L-Olanda Pfizer Animal Health B.V. Rivium
Danish: Flumix 50% super WO Flumequin
Maltese: Flumix 50% super WO Flumequine
Danish: Bleijenhoek 17
Maltese: Pleinlaan 17
Danish: Danofloxacin 31,73 mg/ml (svarende til 25 mg/ml
Maltese: Danofloxacin 31.73 mg/ml (ekwivalenti għal 25 mg/ml
Danish: Enrocoli oral solution Enrofloxacin Colistinsulfat
Maltese: Enrocoli oral solution Enrofloxacin Colistin sulphate
Danish: Oxolinsyre, natriumsalt
Maltese: Oxolinic acid, sodium salt
Danish: Enrofloxacin Colistinsulfat C-vitamin
Maltese: Enrofloxacin Colistin sulphate Vitamin C
Danish: Flumesyva Oral paste Flumequin
Maltese: Oral paste Flumequine
Danish: Inoxyl Solution Buvable Oxolinsyre
Maltese: Inoxyl Solution Buvable Oxolinic acid 50 mg
Danish: Leijsendwarsstraat 26
Maltese: L-Olanda Wirtz Farma B.V. Leijsendwarsstraat 26
Danish: 1107 Budapest HUNGARY
Maltese: 1107 Budapest
Danish: B. For lægemidler i bilag I indeholdende quinoloner (flumequin, oxolinsyre): 12.
Maltese: Għall-prodotti elenkati fl-Anness I li fihom kwinoloni (flumequine, oxolinic acid): 12.
Danish: 40064 Ozzano dell' Emilia (BO)
Maltese: Ozzano dell' Emilia (BO) ITALY
Danish: Rumænien Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona
Maltese: Ir-Rumanija Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona
Danish: • for 132 af de produkter, som blev identificeret af medlemsstaterne, indsendte ansøgerne/indehaverne af markedsføringstilladelserne eller de nationale myndigheder ingen eller utilstrækkelige oplysninger til CVMP, og der kunne derfor ikke drages nogen konklusioner med hensyn til tilgængelighed eller med hensyn til, om der var tilstrækkelige forsigtighedsregler i produktresuméet anbefaler udvalget en ændring af betingelserne for markedsføringstilladelserne til lægemidler indeholdende quinoloner, herunder fluoroquinoloner, beregnet til arter til levnedsmiddelproduktion som indbragt i bilag I for at ændre produktresuméet og indlægssedlen i de tilfælde, hvor disse ikke er i overensstemmelse med CVMP's debatoplæg (EMEA/CVMP/416168/2006).
Maltese: • għall-132 prodott identifikati mill-Istati Membri ma kien hemm l-ebda informazzjoni disponibbli jew l-informazzjoni ma kinitx biżżejjed għas-CVMP mingħand l-Applikanti/id-Detenturi talAwtorizzazzjoni għat-Tqegħid fis-Suq jew awtoritajiet nazzjonali u għaldaqstant ma setgħet issir lebda konklużjoni dwar id-disponibbiltà jew evalwazzjoni dwar l-adegwatezza ta' frażijiet ta' prekawzjoni fis-Sommarju tal-Karatteristiċi tal-Prodott; il-Kumitat jirrakkomanda l-varjazzjoni tat-termini tal-awtorizzazzjonijiet għat-tqegħid fis-suq ta' prodotti li fihom il-kwinoloni inklużi fluworokwinoloni maħsuba għall-ispeċijiet li jipproduċu l-ikel kif imsemmija fl-Anness I sabiex jiġu emendati s-Sommarju tal-Karatteristiċi tal-Prodott u l-Fuljetti ta' Tagħrif f'dawk il-każijiet fejn m'hemmx konformità mad-Dokument ta' Riflessjoni tas-CVMP (EMEA/CVMP/416168/2006).
Danish: Danofloxacinmesilat
Maltese: Danofloxacin mesilate
Danish: Baytril 5 mg/mlLösung zum Eingeben für Schweine
Maltese: Baytril 5 mg/ml - Lösung zum Eingeben für Schweine
Danish: Handelsweg 25
Maltese: Kontichsesteenweg 42
Danish: Schippers Europe B.V.
Maltese: L-Olanda Schippers Europe B.V. Bleijenhoek 17
Danish: Lda.Beloura Oficial Parque Edif.
Maltese: VIRBAC - Portugal Laboratórios Lda.Beloura Oficial Parque Edif. 13 - piso 1 escritorio 3
Danish: Flumix Poudre A 3 % Flumequin
Maltese: Flumix Poudre A 3 % Flumequine
Danish: Efter et fokusgruppemøde i CVMP med deltagelse af de berørte parter og medlemsstaterne vedtog CVMP et "Reflection paper on the use of Fluoroquinolones in food-producing animals - Precautions for use in the SPC regarding prudent use guidance" (EMEA/CVMP/416168/2006), som beskriver de særlige advarsler, der skal medtages i produktresuméet, som følger:
Maltese: Wara laqgħa tal-grupp fokali tas-CVMP mal-Partijiet Interessati u l-Istati Membri, is-CVMP adotta dokument ta' Riflessjoni dwar l-użu tal-Fluworokwinoloni fl-annimali li jipproduċu l-ikel - Prekawzjonijiet għall-użu flSPC rigward il-gwida għall-użu prudenti (EMEA/CVMP/416168/2006) li jagħti dettalji dwar il-frażijiet ta' prekawzjoni li għandhom ikunu inklużi fis-Sommarju tal-Karatteristiċi tal-Prodott, kif ġej:
Danish: Veterinærlægemidler, som indeholder alle de korrekte advarsler om forsigtig brug i punkt 4 i produktresuméet, præcis som CVMP's anbefaling, og veterinærlægemidler, som indeholder alle advarsler om forsigtig brug i punkt 4 i produktresuméet, som ikke præcis er den tekst, der anbefales af CVMP, men som indeholder det samme budskab Veterinærlægemidler, som indeholder advarsler om forsigtig brug i punkt 4 i produktresuméet, men som ikke tilstrækkeligt afspejler CVMP's anbefalinger Veterinærlægemidler, som ikke indeholder advarsler om forsigtig brug i punkt 4 i produktresuméet Veterinærlægemidler, som ansøgerne/indehaverne af markedsføringstilladelserne eller de kompetente nationale myndigheder ikke har indsendt oplysninger om, og hvor det derfor ikke var muligt at vurdere de eksisterende advarsler i produktresuméet.
Maltese: Prodotti mediċinali veterinarji li fihom it-twissijiet kollha tajbin ta' użu prudenti fis-sezzjoni 4 tal-SPC (Prekawzjonijiet speċjali għall-użu), eżatt bħarrakkomandazzjoni tas-CVMP u prodotti mediċinali Veterinarji li fihom it-twissijiet kollha ta' użu prudenti fis-sezzjoni 4 tal-SPC, li madankollu m'humiex eżattament il-kitba rrakkomandata mis-CVMP, iżda li jgħaddu l-istess messaġġi ewlenin Prodotti mediċinali veterinarji li fihom twissijiet ta' użu prudenti fis-sezzjoni 4 talSPC iżda li ma jirriflettux b'mod adegwat ir-rakkomandazzjonijiet tas-CVMP Prodotti mediċinali veterinarji li ma fihomx twissijiet ta' użu prudenti fis-sezzjoni 4 tal-SPC Prodotti li għalihom ma ġiet sottomessa l-ebda informazzjoni millApplikanti/Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq jew awtoritajiet nazzjonali kompetenti u li għaldaqstant għalihom ma setgħetx issir evalwazzjoni tat-twissijiet eżistenti fl-SPC Total It-twissijiet fl-SPC tal-(fluworo)kwinoloni kienu sodisfaċenti għal 318-il prodott, u għaldaqstant m'hemmx ħtieġa ta' aktar azzjoni għal dawn il-prodotti.
Danish: VetPharma Animal Health S.L.
Maltese: VetPharma Animal Health S.L. Les Corts, 23
Danish: Colistinsulfat Oxolinsyre
Maltese: Colistin sulphate Oxolinic acid
Danish: de Castellvell nº 24 43206 Reus (Tarragona) SPAIN
Maltese: Laboratorios Serra Pamies, S.A. Ctra. de Castellvell nº 24 43206 Reus (Tarragona)
Danish: Flumesyva Liquid 20% Flumequin
Maltese: Flumesyva Liquid 20% Flumequine
Danish: Samlet resumé af den faglige vurdering af veterinærlægemidler indeholdende (fluoro)quinoloner (se bilag I)
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' prodotti mediċinali veterinarji li fihom (fluoro)kwinoloni (ara anness I)
Danish: Flumexil 1.5% Flumequin
Maltese: Flumexil 1.5% Flumequine
Danish: Kat
Maltese: Kent
Danish: Inoxyl Poudre Orale Oxolinsyre
Maltese: Inoxyl Poudre Orale Oxolinic acid 100 mg
Danish: 1854 47020 Longiano (FC) ITALY
Maltese: Neofarma Srl Via Emilia Km 18n. 1854 47020 Longiano (FC) ITALY
Danish: Flumiquil Poudre A 3 % Flumequin
Maltese: Flumiquil Poudre A 3 % Flumequine
Danish: Rumænien Vétoquinol Biowet Sp. z o.o.
Maltese: Ir-Rumanija Vétoquinol Biowet Sp. z o.o. ul.
Danish: Farmavet OOD 40 Otec Paisij Str. 9700 Shumen BULGARIA
Maltese: Il-Bulgarija Farmavet OOD 40 Otec Paisij Str.
Danish: Grækenland Ceva Hellas S.A. Ag. Nikolaou 15
Maltese: Il-Greċja Ceva Hellas S.A. Ag.
Danish: Powerflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats
Maltese: Powerflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Qtates
Danish: Şos.
Maltese: Av.
Danish: Pfizer Animal Health Benelux Division Pleinlaan 17
Maltese: Il-Belġju Pfizer Animal Health Benelux Division
Danish: Rumænien Laboratorios Hipra, S.A. Avda.
Maltese: Ir-Rumanija Laboratorios Hipra, S.A. Avda.
Danish: Enrofloxacin Ingen tilgængelige oplysninger
Maltese: Enrofloxacin Ebda informazzjoni disponibbli
Danish: 105b 06406 Bernburg GERMANY
Maltese: Il-Ġermanja Serumwerk Bernburg AG Hallesche Landstr. 105b 06406 Bernburg
Danish: Vétoquinol Biowet Sp. z o.o.
Maltese: Vétoquinol Biowet Sp. z o.o. ul.
Danish: 1126 Budapest HUNGARY
Maltese: 1126 Budapest
Danish: Quinocol Oral Solution Enrofloxacin Colistinsulfat
Maltese: Quinocol oral solution Enrofloxacin Colistin sulphate
Danish: Quinocol oral solution Enrofloxacin Colistinsulfat
Maltese: Quinocol Oral Solution Enrofloxacin Colistin sulphate
Danish: Hunde Katte
Maltese: Majjali Dog
Danish: Kvæg (ikke mælkeproducerende)
Maltese: Bovini (li ma jipproduċux ħalib)
Danish: Oxolinsyre 100 g
Maltese: Oxolinic acid 100g
Danish: Kaniner Pelsdyr
Maltese: Fur animals
Danish: Rumænien Laboratorios Karizoo, S.A. Polg.
Maltese: Ir-Rumanija Laboratorios Karizoo, S.A. Polg.
Danish: Ørred
Maltese: Arques
Danish: Pfizer Corporation Austria GmbH
Maltese: L-Awstrija Pfizer Corporation Austria GmbH Floridsdorfer Hauptstaße 1
Danish: Ansøger/indehaver af markedsførings-tilladelse
Maltese: Applikant/ Detentur talAwtorizzazzjoni għatTqegħid fis-Suq
Danish: FLUMIQUIL 50% plv.
Maltese: FLUMIQUIL 50% plv. sol.
Danish: Flumisol 36 % Flumequin
Maltese: Flumisol 36 % Flumequine
Danish: Mayflus Suspension Oral
Maltese: Mayflus Suspension Oral Flumequine
Danish: 25,82 g amoxicillintrihyd rat
Maltese: 82 g amoxicillin trihydrate 15 g flumequine
Danish: Amoxicillin Flumequin
Maltese: Amoxicillin trihydrate Flumequine
Danish: 43330 Riudoms (Tarragona) SPAIN
Maltese: Ctra. de Reus a Vignols km 4.1 43330 Riudoms (Tarragona)
Danish: Kalve Svin
Maltese: Tjur Fniek
Danish: 18. maj 2018
Maltese: Laqgħa tas-CMDh Marzu 2018
Danish: Oversættelser af bilagene til indstillingen fremsendes til de relevante nationale myndigheder:
Maltese: Trażmissjoni lill-Awtoritajiet Nazzjonali Kompetenti tat-traduzzjonijiet tal-annessi għallpożizzjoni:
Danish: Vedtagelse af CMDh's standpunkt ved konsensus: CMDh's møde i marts 2018
Maltese: Adozzjoni tal-pożizzjoni tas-CMDh b'kunsens:
Danish: 18. april 2018
Maltese: Implimentazzjoni tal-pożizzjoni mill-Istati Membri: 18/05/2018
Danish: Overordnet konklusion
Maltese: Konklużjoni globali
Danish: I 2013 blev der indledt en hasteprocedure i henhold til artikel 107i i direktiv 2001/83/EF (EMEA/H/A107i/1363) som følge af den øgede indberetning af levertoksiske reaktioner i forbindelse med flupirtin.
Maltese: Fl-2013, inbdiet proċedura tal-unjoni urġenti skont l-Artikolu 107i tad-Direttiva 2001/83/KE (EMEA/H/A-107i/1363) wara r-rappurtar miżjud ta' reazzjonijiet ta' epatotossiċità b'assoċjazzjoni ma' flupirtine.
Danish: PRAC vedtog den 8. februar 2018 en anbefaling, der efterfølgende er blevet vurderet af CMDh i overensstemmelse med artikel 107k i direktiv 2001/83/EF.
Maltese: Il-PRAC adotta rakkomandazzjoni, fit-8 ta' Frar 2018 li dak iż-żmien ġiet ikkunsidrata mis-CMDh, skont l-Artikolu 107k tad-Direttiva 2001/83/KE.
Danish: Der er desuden beskrevet en fremmende virkning på gammaaminobutansyre-A-receptorer.
Maltese: Barra minn hekk, ġie deskritt effett faċilitatorju fuq riċetturi ta' aċidu gamma-aminobutirriku A.