natgillin/translations-raw huggingface dataset:
11.5 g/100 g Oral powder 
11,5 g/100 g Perorálny prášok
Flumix 50% super WO Flumequine 
Flumix 50% super WO Flumechin
Floridsdorfer Hauptstaße 1 1210 Wien 
Floridsdorfer Hauptstaße 1
Farmequine 20% L 
Farmequine 20%
Industrial La Borda Mas Pujades, 11-12 08140 Caldes de Montbui (Barcelona) 
Industrial La Borda Mas Pujades, 11-12 08140
Veterinary medicinal products that contain prudent use warnings in section 4 of the SPC but which do not adequately reflect the CVMP recommendations; Group 3. 
Veterinárne lieky, ktoré obsahujú upozornenia na obozretné používanie v 4. časti súhrnu charakteristických vlastností lieku, ale ktoré adekvátne neodzrkadľujú odporúčania výboru CVMP;
Marbocyl 50mg Bolus Marbofloxacin 50 mg 
Marbocyl 50mg Bolus Marbofloxacín 50 mg
Denmark Ceva Santé Animale Zone Industrielle La Ballastiere 
Taliansko Ceva Santé Animale Zone Industrielle La Ballastiere
Sintofarm S.p.A. 
Taliansko Sintofarm S.p.A.
Biovet AD 39 Petar Rakov Str. 4550 Peshtera BULGARIA 
Bulharsko Biovet AD 39 Petar Rakov Str.
DENMARK 
Dánsko
Romania Kepro B.V. Maagdenburgstraat 38 7421 ZE Deventer NETHERLANDS 
Maagdenburgstraat 38 7421
Authorisation Holders or competent national authorities and for which no assessment of the existing SPC warnings was therefore possible. 
Produkty, pre ktoré žiadatelia/držitelia povolenia na uvedenie lieku na trh alebo príslušné vnútroštátne úrady nepredložili žiadne informácie, a v prípade ktorých sa preto nemohli posúdiť existujúce upozornenia v súhrne charakteristických vlastností lieku.
Baytril oral solution Enrofloxacin 5 mg/ml 
Baytril oral solution Enrofloxacín 5 mg/ml
1854 47020 Longiano (FC) ITALY 
Srl Via Emilia Km 18n. 1854 47020 Longiano (FC)
Flumesyva Premezcla Flumequine 
Flumesyva Premezcla Flumechin
Romania S.C. ROMVAC COMPANY S.A. Şos. 
ROMVAC COMPANY S.A.
Flumesyva Pasta Oral 
Flumesyva Pasta
Flumesyva Oral paste Flumequine 
Oral paste Flumechin
Hungary Orion Corporation Orionintie 1A 
Maďarsko Orion Corporation
13 - piso 1 escritorio 3 Quinta da Beloura 2710-444 Sintra PORTUGAL 
Lda.Beloura Oficial Parque Edif. 13 - piso 1 escritorio 3 Quinta da Beloura 2710-444
Hungary Ascor Chimici S.r.l. 
Maďarsko Ascor Chimici S.r.l.
Summary of Product Characteristics concerning 564 products of the 696 included in the referral were submitted by the Applicant/Marketing Authorisation Holders and competent national authorities to the CVMP for review. 
Žiadatelia/držitelia povolenia na uvedenie lieku na trh a príslušné vnútroštátne úrady predložili na preskúmanie výboru CVMP súhrn charakteristických vlastností lieku pre 564 produktov zo 696 produktov zahrnutých do tohto konania.
Romania Orion Corporation Orionintie 1A 
Rumunsko Orion Corporation
KARIFLOX 5 mg/ml oral solution for piglets 
5 mg/ml oral solution for piglets
Animal species Route(s) of administration 
Druh zvieraťa Spôsob(y) podania
Andreotti Farmaceutical Srl Via Eridania Ovest 65 45030 Guarda Veneta (RO) ITALY 
Taliansko Andreotti Farmaceutical Srl Via Eridania Ovest 65
Industrial Veterinaria S.A. Esmeralda, 19 - 4º 08950 Esplugues de Llobregat SPAIN 
Esmeralda, 19 - 4º 08950
Animal Health Division Energieweg 1 
Holandsko Bayer B.V. Animal Health Division Energieweg 1
3 43206 Reus 
Reus-Cambrils, Km. 3 43206 Reus
50 mg/ml enrofloxacin 500 000 IU/ml colistin sulphate 
50 mg/ml enrofloxacínu 500 000 IU kolistín sulfátu
Chanelle Pharmaceuticals Manufacturing Limited IDA Business & Technology Park 
Chanelle Pharmaceuticals Manufacturing Limited IDA Business
40064 Ozzano dell' Emilia (BO) 
Ozzano Emilia (BO)
de Castellvell nº 24 43206 Reus (Tarragona) SPAIN 
43206 Reus (Tarragona)
Marbofloxacin 10% w/v 
Marbofloxacín 10 % w/v
Marbocyl 10% Marbofloxacin per ml: marbofloxacin 
Marbocyl 10% Marbofloxacín na ml: marbofloxacín
Hungary Chanelle Pharmaceuticals Manufacturing Limited IDA Business & Technology Park 
Maďarsko Chanelle Pharmaceuticals Manufacturing Limited IDA Business
Romania Pfizer Animal Health Ramsgate Road 
Rumunsko Pfizer Animal Health Ramsgate Road
Farmavet OOD 40 Otec Paisij Str. 9700 Shumen BULGARIA 
Bulharsko Farmavet OOD 40 Otec Paisij Str.
Vétoquinol B.V. 
Holandsko Vétoquinol B.V.
Poultry 
Sliepky
100 g/1000 g Oral powder 
100 g/1 000 g Perorálny prášok
Flumiquil Poudre A 3 % Flumequine 
Flumiquil Poudre A 3 % Flumechin
E-Flox Solucion Oral 
E-Flox Solucion
Marbofloxacin 2% w/v 
Marbofloxacín 2 % w/v
Inoxyl Solution Buvable Oxolinic acid 50 mg 
Inoxyl Solution Buvable Kyselina oxolinová
Hungary VMD Állatgyógyászati Kft. Közraktár u. 22/b. 
Közraktár u. 22/b.
Gastroenteral 
Gastroenterálne
Virbac S.A. via dei Gracchi, 30 20146 Milano (MI) ITALY 
Taliansko Virbac S.A. via dei Gracchi, 30
Kenflox 20% Oral 
Kenflox 20%
Ganadil Flumequina Polvo Oral 
Ganadil Flumequina Polvo
ICC-O-Flu 50% Flumequine 
ICC-O-Flu 50%
Romania Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona 
Rumunsko Universal Farma, S.L Gran Via Carlos III 98-7a 08028
ENROBIOFLOX 10 % (w/v) perorální roztok 
10 % (w/v) perorální roztok
Romania Dar al Dawa Veterinary & Agricultural Industrial Co. Ltd. Jordan Na`ur 11710 
Rumunsko Dar al Dawa Veterinary & Agricultural Industrial Co.
Laboratorios Syva, S.A. Avda Parroco Pablo Diez 49 
Avda Parroco Pablo Diez 49
Schippers Europe B.V. Bleijenhoek 17 
Holandsko Schippers Europe B.V.
Amendments to be included in the relevant sections of the package leaflet 
Do príslušných častí písomnej informácie pre používateľov majú byť zahrnuté tieto zmeny a doplnenia:
Romania Ascor Chimici S.r.l. 
Rumunsko Ascor Chimici S.r.l.
Flumexil 1.5% Flumequine 
Flumexil 1.5% Flumechin
Broilers Rabbits 
Brojlery Králiky
Enrofloxacin 0.10 g 
Enrofloxacín 0,10 g
Syvaquinol-10% Oral 
Syvaquinol-10%
Laboratorios Dr Esteve, S.A. Avda. 
Španielsko Laboratorios Dr Esteve, S.A.
• adequate precautionary phrases related to the use of (fluoro)quinolones intended for foodproducing species have been included in Summary of the Product Characteristics for 318 products concerned by this referral; 
• do súhrnu charakteristických vlastností lieku pre 318 produktov zahrnutých do tohto konania boli zahrnuté adekvátne výroky týkajúce sa upozornení na použitie (fluór)chinolónov určených pre druhy zvierat produkujúce potraviny,
Salmon Trout 
Losos Pstruh
Romania S.C. CRIDA PHARM S.R.L. 
CRIDA PHARM S.R.L.
Hungary Ceva-Phylaxia Co. Ltd. Szállás u. 5. 
Maďarsko Ceva-Phylaxia Co.
Marbocyl 10% Marbofloxacin 10% 
Marbocyl 10% Marbofloxacín 10 %
Goats 
Kozy
Cofamix Acide Oxolinique 40 Volaille 
Oxolinique 40 Volaille
Danofloxacin 180 mg 
Danofloxacín 180 mg
Enrofloxacina Premix Enrofloxacin 50 mg/g 
Enrofloxacina Premix Enrofloxacín 50 mg/g
Poultry Calves Dogs Cats 
Hydina Teľatá Psy Mačky
Hungary Lavet Gyógyszergyártó Kft. Ottó u. 14 
Maďarsko Lavet Gyógyszergyártó Kft.
Marbofloxacin 10% 
Marbofloxacín 10 %
Subcutaneous intravenous 
Podkožne vnútrožilovo
Oxolinic acid, sodium salt 
Kyselina oxolinová, sodná soľ
• no precautionary phrases related to the use of (fluoro)quinolones intended for food-producing species have been included in Summary of the Product Characteristics of 83 products concerned by this referral; 
• do súhrnu charakteristických vlastností lieku pre 83 produktov zahrnutých do tohto konania neboli zahrnuté žiadne výroky týkajúce sa upozornení na použitie (fluór)chinolónov určených pre druhy zvierat produkujúce potraviny,
Marbofloxacin 2% 
Marbofloxacín 2 %
Poultry Rabbits 
Kurčatá Králiky
HIPRALONA ENRO-I inj Enrofloxacin 50 mg/ml 
HIPRALONA ENRO-I inj Enrofloxacín 50 mg/ml
Ruminating calves 
Ruminujúce teľatá
Lithuania Pfizer Animal Health Ramsgate Road 
Lotyšsko Pfizer Animal Health Ramsgate Road
Young poultry (chickens and turkeys) 
Mladá hydina (kurčatá a morky)
Marbocyl 2 % Marbofloxacin 2% 
Marbocyl 2 % Marbofloxacín 2 %
Inoxyl Poudre Orale Oxolinic acid 100 mg 
Inoxyl Poudre Orale Kyselina oxolinová
Colistin sulphate Oxolinic acid 
Kolistín sulfát Kyselina oxolinová
Labiana Life Science, S.A. Venus 26 - Can Parellada Industrial 
Venus 26 - Can Parellada
Enrocoli oral solution Enrofloxacin Colistin sulphate 
Enrocoli oral solution Enrofloxacín Kolistín sulfát
Germany Albrecht GmbH Hauptstr. 
Nemecko Albrecht GmbH Hauptstr. 6 - 8
Danofloxacin 25 mg 
Danofloxacín 25 mg
Exotic pet animals 
Exotické domáce zvieratá
Marbofloxacin 50 mg/tablet 
Marbofloxacín 50 mg/tabletu
2160 Wommelgem BELGIUM 
Caluwaertstraat 1 2160 Wommelgem BELGIUM
Cattle Birds 
Poľovnícke vtáky
Oxolinic acid 50 g 
Kyselina oxolinová 100 g
Hungary Abo-Mix Co. Ltd. Simai u. 6 
Maďarsko Abo-Mix Co.
Enrofloxacino Solucion Oral 
Enrofloxacino Solucion
Polichem, S.A. 
Španielsko Polichem, S.A.
Pigeons 
Holuby
Danofloxacin 180 mg/ml 
Danofloxacín 180 mg/ml
Laboratórios Pfizer Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo PORTUGAL 
Portugalsko Laboratórios Pfizer Lda Lagoas Park, Edifício 10
Enrocare 5 % Solution Injectable Pour Bovins, Porcs, Chiens et Chats 
5 % Solution Injectable Pour Bovins, Porcs, Chiens et Chats
Lambs, Kids, Piglets, Rabbits, Dogs 
Hlodavce (králiky, morčatá, myši, škrečky)
Flumequine 10% pulvis Flumequine 
Flumequine 10% pulvis Flumechin
Flumisol 36 % Flumequine 
Flumisol 36 % Flumechin
Pre-ruminant Cattle 
Preruminantný hovädzí dobytok
Fish Pigs Calves Poultry 
Ryby Ošípané Teľatá Hydina
Enrofloxacin 10% 
Enrofloxacín 10 %
Flumequine Durden Flumequine 
Durden Flumechin
Amendment to the summary of product characteristics and package leaflet 
Zmeny a doplnenia v súhrne charakteristických vlastností lieku a v písomnej informácii pre používateľov
Baytril Injection 5% Enrofloxacin 5 g/100 ml 
Baytril Injection 5% Enrofloxacín 5 g/100 ml
Intrauterine 
Injection
1MUI/g Colistin sulphate 200mg/g oxolinic acid 
200 mg/g kyseliny oxolinovej
Cattle (non ruminating) 
Hovädzí dobytok (neruminujúci)
DELTAVIT 
Francúzsko DELTAVIT
Enrofloxarom Forte Enrofloxacin 50 mg/tablet 
Enrofloxarom Forte Enrofloxacín 50 mg/tabletu Tablety
VETAFLUMINA 5% Flumequine 
VETAFLUMINA 5% Flumechin
Gandexil Enrofloxacina Enrofloxacin 100 mg/ml 
Gandexil Enrofloxacina Enrofloxacín 100 mg/ml
Solution for injection Calves 
Solution for Injection
Baytril Piglet Doser 0.5% Oral Solution 
Baytril Piglet Doser 0.5%
Hungary Laboratorios Karizoo, S.A. Polg. 
Maďarsko Laboratorios Karizoo, S.A.
Enrofloxacin 200 g/1000 ml 
Enrofloxacín 200 g/1 000 ml
7 44153 Ancenis Cedex FRANCE 
44153 Ancenis
Cattle Sheep 
Hovädzí dobytok Ovce
Danofloxacin 25 mg/ml 
Danofloxacín 25 mg/ml
Difloxy 10 % oral solution for chicken and turkey 
% oral solution for chicken and turkey
Enrofloxacin 5% 
Enrofloxacín 5 %
BAYTRIL Oplossing 2,5% Oraal 
BAYTRIL Oplossing 2,5%
Enrofloxacin Colistin sulphate 
Enrofloxacín Kolistín sulfát
Intravenous, subcutaneous 
Vnútrožilovo, podkožne
Intramuscular, intravenous 
Podkožne intramuscular, intravenous
Bayer Portugal SA Rua Quinta do Pinheiro, 5 2794-003 Carnaxide PORTUGAL 
Portugal SA Rua Quinta do Pinheiro, 5
Alsir 10% Solucion Oral Enrofloxacin 100 mg/ml 
Alsir 10% Solucion Oral Enrofloxacín 100 mg/ml
Cofamix Acide Oxolinique 80 Porc 
Oxolinique 80 Porc
Pigs, Sheep, Birds 
Ošípané Ovce Vtáky
Enrofloxacin 100 g/l 
Enrofloxacín 100 g/l
80052 Portici (NA) ITALY 
Portici (NA)
Poultry (excluding laying) 
Sliepky (okrem nosníc)
Pigs Fish 
Ošípané Ryby
Marbofloxacin 50 mg 
Marbofloxacín 50 mg
Intravenous 
Vnútrožilovo
Soluble powder 
Fluquick Poudre
Flumequine 10% WSP Flumequine 
Flumequine 10% WSP Flumechin
Poultry Pigs 
Ošípané Kurčatá
Cattle (suckling calves) 
Hovädzí dobytok (dojčené teľatá)
Enrofloxacin 5 g/100 g 
Enrofloxacín 5 g/100 g
Bovine 
Hovädzí dobytok
Enrofloxacin 2.5% 
Enrofloxacín 2,5
Laboratorios Syva, S.A. arroco Pablo Diez, 49-57 24010 Trobajo Del Camino SPAIN 
Španielsko Laboratorios Syva, S.A. arroco Pablo Diez, 49-57
Roxacin Inyectable Enrofloxacin 100 mg/ml 
Roxacin Inyectable Enrofloxacín 100 mg/ml
Romania Bayer HealthCare AG Animal Health Division 51368 Leverkusen 
Bulharsko Bayer HealthCare AG Animal Health Division 51368 Leverkusen
Medicated feed 
Nutrition Animale
Flumequinorom 10% Flumequine 
Flumequinorom 10% Flumechin
Flumechina 20% Liquida 
Flumechina 20%
Broilers 
Brojlery
Sanofi Santè Nutrition Animale , La Ballestière - Bp 126 , 33051, Francia 
, La Ballestière - Bp 126
Marbofloxacin 20 mg/ml 
Marbofloxacín 20 mg/ml
Hungary Laboratorios Hipra, S.A. Avda. 
Maďarsko Laboratorios Hipra, S.A.
Enrofloxacin 0.5% 
Enrofloxacín 0,5
Poultry (chickens and turkeys) 
Hydina (kurčatá a morky)
Filozoo Srl 
Taliansko Filozoo
Flumequine Amoxicillin trihydrate 
FlumechinAmoxi cilín trihydrát
Enrofloxacin 200 mg 
Enrofloxacín 200 mg
Subcutaneous 
Podkožne
5531 AE Bladel THE NETHERLANDS 
5531 AE
Flumequine 50% WSP Flumequine 
Flumequine 50% WSP Flumechin
Flumequine 50 % WSP Flumequine 
Flumequine 50 % WSP Flumechin
10% Enrofloxacin 100 mg/g 
10% Enrofloxacín 100 mg/g
Poulrty 
Úhory
Trout 
Pstruh
Marbofloxacin 100 mg 
Marbofloxacín 100 mg
Enrocin 5% inj., enrofloksacyna 50mg/ml solution for injection for cattle and pig 
5% inj., enrofloksacyna 50mg/ml solution for injection for cattle and pig
Subcutaneous or intraveneous or intramuscular 
Podkožne alebo vnútrožilovo alebo vnútrosvalovo
Marbofloxacin 20 mg 
Marbofloxacín 20 mg
Quinocol oral solution Enrofloxacin Colistin sulphate 
Quinocol Oral Solution Enrofloxacín Kolistín sulfát
Lambs Rabbits Pigs 
Ošípané Králiky
Baytril 10 % injection Enrofloxacin 100 mg/ml 
Baytril 10 % injection Enrofloxacín 100 mg/ml
Cattle Pigs Dogs Cats 
Hovädzí dobytok Prasiatka Psy
Ascor Chimici S.r.l. 
Taliansko Ascor Chimici S.r.l.
Poultry (broilers and turkeys) 
Hydina (brojlery a morky)
Romania Dopharma Research BV Zalmweg 24 
Rumunsko Dopharma Research BV Zalmweg 24
Marbocyl 2% Marbofloxacin Marbofloxacin 2.0 % w/v 
Marbocyl 2% Marbofloxacín Marbofloxacín 2,0
Broilers Turkeys 
Brojlery Morky
Calves Pigs 
Teľatá Ošípané
Enrokarizoo 10% Enrofloxacin 10 g/100 ml 
Enrokarizoo 10% Enrofloxacín 10 g/100 ml
Marbocyl 2 % injection Marbofloxacin 20 mg/ml 
Marbocyl 2 % injection Marbofloxacín 20 mg/ml
Enrofloxacin 50 mg/ml 
Enrofloxacín 50 mg/ml
Enrofloxacin 100 g/1000 ml 
Enrofloxacín 100 g/1 000 ml
Enrofloxacin 2.5 g/100 ml 
Enrofloxacín 2,5 g/100 ml
Baytril 5 % injection Enrofloxacin 50 mg/ml 
Baytril 5 % injection Enrofloxacín 50 mg/ml
Enrofloxacin 100 mg/g 
Enrofloxacín 100 mg/g
Cattle Lambs Kids Piglets Poultry Rabbits 
Kurčatá Ošípané Teľatá Jahňatá Kozľatá Králiky
Enrofloxacin 25 mg 
Enrofloxacín 25 mg
Amoxicillin 22,5% + Flumequine 15% 
Amoxicillin 22,5%
25191 Lérida 
25125 Brescia
Romania Lavet Gyógyszergyártó Kft. Ottó u. 14 
Rumunsko Lavet Gyógyszergyártó Kft.
Enrofloxacino Universal 
Enrofloxacino
20041 Agrate Brianza (MI) ITALY 
20146 Milano (MI)
Syvaquinol 10% Enrofloxacin 100 mg/ml 
Syvaquinol 10% Enrofloxacín 100 mg/ml
Ursofloxacin 5% Enrofloxacin 50 mg/ml 
Ursofloxacin 5% Enrofloxacín 50 mg/ml
Marbocyl 2 % Marbofloxacin 20 mg 
Marbocyl 2 % Marbofloxacín 20 mg
Enrofloxacin 100 mg 
Enrofloxacín 100 mg
Hungary Vétoquinol Biowet Sp. z o.o. 
Maďarsko Vétoquinol Biowet Sp. z o.o.
Fenoflox 5 % Enrofloxacin 100 mg/ml 
Fenoflox 5 % Enrofloxacín 100 mg/ml
Kariflox 2,5 % Solution Buvable Pour Veaux 
% Solution Buvable Pour Veaux
Grounds for amendment of the summary of product characeristics and package leaflet 
Odôvodnenie zmien a doplnení v súhrne charakteristických vlastností lieku a v písomnej informácii pre používateľov
Enrofloxacin 250 mg 
Enrofloxacín 250 mg
Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda. 
Portugalsko Ceva Saúde Animal - Produtos Farmacêuticos e
Pigs Lambs Cattle Hens Turkeys 
Rozpustný prášok Ošípané Hovädzí dobytok Hydina
Recommendations for prudent use “Official and local antimicrobial policies should be taken into account when the product is used.” “Whenever possible, quinolones should only be used based on susceptibility testing.” “Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the quinolones and may decrease the effectiveness of treatment with other (fluoro)quinolones due to the potential for cross resistance.” 
„Použitie produktu, ktoré sa odchyľuje od pokynov uvedených v súhrne charakteristických vlastností lieku, môže zvýšiť výskyt baktérií rezistentných voči chinolónom a môže znížiť účinnosť liečby inými (fluór)chinolónmi v dôsledku potenciálu skríženej rezistencie.”
Poultry Cattle Fur animals 
Hovädzí dobytok Ryby
Enrofloxacin 10 g/100ml 
Enrofloxacín 10 g/100ml
Enrofloxacin 500 mg/g 
Enrofloxacín 500 mg/g
Enrofloxacin 5 mg 
Enrofloxacín 5 mg
Oral suspension 
Solucion Oral
Enrofloxacin 150 mg 
Enrofloxacín 150 mg
Enrofloxacin 15 mg 
Enrofloxacín 15 mg
Hipralona Enro - I 
Enro - I
Flumiquil 50 % Flumequine 
Flumiquil 50 % Flumechin
Romania Laboratorios Karizoo, S.A. Polg. 
Rumunsko Laboratorios Karizoo, S.A.
Enrofloxacin 50 mg/g 
Enrofloxacín 50 mg/g
Flumequine 10% Flumequine 
Flumequine 10% Flumechin
Enrofloxacin 10 g/100 ml 
Enrofloxacín 10 g/100 ml
Enrofloxacin 5 g/100 ml 
Enrofloxacín 5 g/100 ml
Romania Vétoquinol Biowet Sp. z o.o. 
Rumunsko Vétoquinol Biowet Sp. z o.o.
Anka-floxacin 10% Enrofloxacin 100 mg/ml 
Anka-floxacin 10% Enrofloxacín 100 mg/ml
Enrofloxacin 25 mg/tablet 
Enrofloxacín 25 mg/tabletu Tablety
Marbocyl 10% Marbofloxacin 100 mg 
Marbocyl 10% Marbofloxacín 100 mg
Enrofloxacin 0.5 g/100 ml 
Enrofloxacín 0,5 g/100 ml
MARBOCYL S 100 mg/ml injekční roztok 
S 100 mg/ml injekční roztok
Flumechina 50% Flumequine 
Flumechina 50%
Enrofloxacin 500 mg 
Enrofloxacín 500 mg
C-Enrox 10% Enrofloxacin 100 mg/ml 
C-Enrox 10% Enrofloxacín 100 mg/ml
Enroxil 10% solution Enrofloxacin 100 mg/ml 
Enroxil 10% solution Enrofloxacín 100 mg/ml
BAYTRIL Oplossing 0,5% Oraal 
BAYTRIL Oplossing 0,5%
Enrovet 10 % solution Enrofloxacin 100 mg/ml 
Enrovet 10 % solution Enrofloxacín 100 mg/ml
Calves Pigs Poultry 
Teľatá Ošípané Kurčatá Morky
Enrovet Inyectable 100 Enrofloxacin 100 mg/ml 
Inyectable 100 Enrofloxacín 100 mg/ml
Leijsendwarsstraat 26 4901 PG Oosterhout THE NETHRLANDS 
PG Oosterhout THE NETHRLANDS
Enrofloxacin 50 mg 
Enrofloxacín 50 mg
Lithuania Lavet Gyógyszergyártó Kft. Ottó u. 14 
Lotyšsko Lavet Gyógyszergyártó Kft.
Romania Laboratorios Hipra, S.A. Avda. 
Rumunsko Laboratorios Hipra, S.A.
10 rue Clement Ader ZA le Patis 78120 Rambouillet FRANCE 
78120 Rambouillet FRANCE
Romania Golashpharma Ltd. 33, Pobeda Str. 
33, Pobeda Str.
Germany Vétoquinol S. A. Magny Vernois 
Nemecko Vétoquinol S. A. Magny Vernois
Concentrat Vo69 Acide Oxolinique 40 Volaille 
Concentrat Vo69 Acide
Marbocyl S, 10% Marbofloxacin 100 mg/ml 
Marbocyl S, 10% Marbofloxacín 100 mg/ml
Cattle Goats Horses Sheep Pigs Poultry 
Ošípané Teľatá Ovce Kozy
Vetoflok 10% Enrofloxacin 100 mg/ml 
Vetoflok 10% Enrofloxacín 100 mg/ml
MARBOCYL 2% inj 
2% inj
Enrofloxarom 5% Enrofloxacin 50 mg/ml 
Enrofloxarom 5% Enrofloxacín 50 mg/ml
Enrofloxacin 5 mg/tablet 
Enrofloxacín 5 mg/tabletu Tablety
Enrofloxacin Oxytetracycline hydrochloride Iodoform25 mg/ml 
Enrofloxacín Oxytetracyklín hydrochlorid
Hungary Krka, d. d., Novo mesto Šmarješka cesta 6 
Maďarsko Krka, d. d., Novo mesto Šmarješka cesta 6
Enrofloxacin 15 mg/tablet 
Enrofloxacín 15 mg/tabletu Tablety
Subcutaneous, intravenous 
Podkožne, vnútrosvalovo
Enroxil 10% oral , enrofloksacyna 100mg/ml solution for use in drinking water for chicken 
, enrofloksacyna 100mg/ml solution for use in drinking water for chicken
Germany Bayer Animal Health GmbH 51368 Leverkusen 
Animal Health GmbH 51368 Leverkusen
Enrofloxacina 5% Enrofloxacin 50 mg/ml 
Enrofloxacina 5% Enrofloxacín 50 mg/ml
Flumesol 10% Flumequine 
Flumesol 10% Flumechin
Flumesyva Liquid 20% Flumequine 
Flumesyva Liquid 20%
Nuova ICC S.r.l. 
S.r.l.
Enrofloxacin 50 mg/tablet 
Enrofloxacín 50 mg/tabletu
ENROBIOFLOX 5 %, injekcinis tirpalas 
5 %, injekcinis tirpalas
Poultry Turkeys 
Kurčatá Morky
Ursofloxacin 10% Enrofloxacin 100 mg/ml 
Ursofloxacin 10% Enrofloxacín 100 mg/ml
Calves Poultry 
Teľatá Kurčatá
Lithuania Laboratorios Hipra, S.A. Avda. 
Lotyšsko Laboratorios Hipra, S.A.
FLUMEXIL 5% Flumequine 
FLUMEXIL 5% Flumechin
Hungary Vétoquinol S. A. Magny Vernois 
Maďarsko Vétoquinol S. A. Magny Vernois
Amoxicillin 22,5% ΚAI Flumequine 15% 
ΚAI Flumequine 15%
Franvet 
Francúzsko Franvet
Ceva Hellas S.A. Ag. Nikolaou 15 
Ag. Nikolaou 15
Flumequine Agroseed 
Agroseed-Candilidis Parapleuros
Enrobioflox 10% Enrofloxacin 100 mg/ml 
Enrobioflox 10% Enrofloxacín 100 mg/ml
Subcutaneous, intramuscular, intravenous 
Podkožne, vnútrosvalovo, intravenous
Enroxil 5 % injection Enrofloxacin 50 mg/ml 
Enroxil 5 % injection Enrofloxacín 50 mg/ml
Cattle Pigs Poultry Rabbits 
Jahňatá Kozľatá Prasiatka Králiky
Laboratorio Jaer S.A. Barcelona, 411 
Španielsko Laboratorio Jaer S.A.
Lithuania Laboratorios Calier, S.A. Barcelonés, 26 
Lotyšsko Laboratorios Calier, S.A.
Enroxil 10 % injection Enrofloxacin 100 mg/ml 
Enroxil 10% injection Enrofloxacín 100 mg/ml
Enroxil 10% injection Enrofloxacin 100 mg/ml 
Enroxil 10 % injection Enrofloxacín 100 mg/ml
MARBOCYL 2% Marbofloxacin 20 mg/ml 
MARBOCYL 2% Marbofloxacín 20 mg/ml
Germany Krka, d.d, Novo mesto Šmarješka cesta 6 
Nemecko Krka, d.d, Novo mesto Šmarješka cesta 6
Intraruminal device Cattle 
Hovädzí dobytok Gastroenterálne
Concentrate for oral solution 
Oral solution
ADVOCIN 2,5% Danofloxacin 25 mg/ml 
% Danofloxacín 25 mg/ml
Flumisol 10 % Flumequine 
Flumisol 10 % Flumechin
Romania Industrial Veterinaria S.A. Esmeralda, 19 - 4º 
Rumunsko Industrial Veterinaria S.A.
• Fluoroquinolone products “Official and local antimicrobial policies should be taken into account when the product is used.” “Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.” “Whenever possible, fluoroquinolones should only be used based on susceptibility testing.” “Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.” 
„Fluórchinolóny by mali byť vyhradené na liečbu klinických stavov, ktoré slabo reagovali na liečbu inými triedami antimikrobiálnych látok, alebo sa predpokladá, že budú slabo reagovať na liečbu týmito látkami.”
Rabbits Fur animals 
Francúzsko Animalcare
Fenoflox 10 % Enrofloxacin 100 mg/ml 
Fenoflox 10% Enrofloxacín 100 mg/ml
Fenoflox 10% Enrofloxacin 100 mg/ml 
Fenoflox 10 % Enrofloxacín 100 mg/ml
Gastroenteral solution 
Gastroenterálny roztok
Enrovet 10% Enrofloxacin 100 mg/ml 
Enrovet 10% Enrofloxacín 100 mg/ml
Enrofloxacina 10% Enrofloxacin 100 mg/ml 
Enrofloxacina 10% Enrofloxacín 100 mg/ml
Romania Vétoquinol S. A. Magny Vernois 
Rumunsko Vétoquinol S. A. Magny Vernois
Germany Krka, d.d., Novo mesto Šmarješka cesta 6 
Nemecko Krka, d. d., Novo mesto Šmarješka cesta 6
Fattening Chickens Fattening Turkeys 
Výkrmné sliepky Morky
Hipralona Enro I 
Hipralona Enro
MARBOCYL S 10% Marbofloxacin 100 mg/ml 
MARBOCYL S 10% Marbofloxacín 100 mg/ml
Belgium Dopharma Research BV Zalmweg 24 
Holandsko Dopharma Research BV Zalmweg 24
Enrofloxacin 10 % Enrofloxacin 100 mg/ml 
Enrofloxacin 10 % Enrofloxacín 100 mg/ml
Romania Krka, d. d., Novo mesto Šmarješka cesta 6 
Rumunsko Krka, d. d., Novo mesto Šmarješka cesta 6
Medicated premix Pigs Poultry 
Rozpustný prášok Hydina Ošípané
Amoxicillina 22,5% + Flumechina 15% 
+ Flumechina 15%
Intravenous, intramuscular, subcutaneous 
Vnútrožilovo, vnútrosvalovo, podkožne
Cattle Lambs Pigs 
Hovädzí dobytok Ošípané
Cattle Pigs Poultry 
Hovädzí dobytok Kurčatá
Hungary S.P. Veterinaria S.A. Ctra. 
Španielsko Industrial Veterinaria S.A.
Marbocyl 10% Marbofloxacin 100 mg/ml 
MARBOCYL 10% Marbofloxacín 100 mg/ml
MARBOCYL 10% Marbofloxacin 100 mg/ml 
Marbocyl 10% Marbofloxacín 100 mg/ml
Enrostar 10% Enrofloxacin 100 mg/ml 
Enrostar 10% Enrofloxacín 100 mg/ml
Enrodem 10% Enrofloxacin 100 mg/ml 
Enrodem 10% Enrofloxacín 100 mg/ml
Group 4 Products for which no information was submitted by the Applicants/Marketing 
• žiadatelia/držitelia povolenia na uvedenie lieku na trh alebo vnútroštátne úrady nepredložili výboru
Romania S.C. Vetorex Srl Str. Turda, nr. 119 
Turda, nr. 119
Cattle Lambs Yeanlings Poultry Birds Rabbits 
Rozpustný prášok Hydina Hovädzí dobytok Králiky
Lithuania Vétoquinol S. A. Magny Vernois 
Lotyšsko Vétoquinol S. A. Magny Vernois
Pigs Dogs Cats 
Prasiatka Psy
Subcutaneous intramuscular 
Podkožne vnútrosvalovo
Cattle Goats Horses Sheep 
Hovädzí dobytok Kozy