natgillin/translations-raw huggingface dataset:
Romania S.C. ROMVAC COMPANY S.A. Şos. 
Romunija S.C. ROMVAC COMPANY S.A. Şos.
15123 Marousi Attikis GREECE 
15123 Marousi Attikis GRČIJA
• quinolones including fluoroquinolones are critical, efficient and valuable antimicrobials for animals and for some serious animal indications, fluoroquinolones are the only effective treatment available; 
• kinoloni, vključno s fluorokinoloni, so ključne, učinkovite in pomembne protimikrobne snovi za živali, saj so pri nekaterih resnih indikacijah pri živalih fluorokinoloni edino razpoložljivo učinkovito zdravilo;
The referral procedure involved 696 veterinary products containing (fluoro)quinolones as identified by the Member States (see Annex I). 
Postopek napotitve je zajel 696 veterinarskih zdravil, za katere so države članice ugotovile, da vsebujejo (fluoro)kinolone.
• the inclusion of specific warnings in the Summary of the Product Characteristics and Package Leaflet of the concerned products is intended to encourage prudent use and help maintain the positive benefit:risk balance for (fluoro)quinolone products; 
• vključitev specifičnih opozoril v povzetek glavnih značilnosti zdravila in navodilo za uporabo zadevnih zdravil naj bi spodbudilo preudarno rabo ter pripomoglo k ohranitvi pozitivnega razmerja med koristmi in tveganji, povezanimi s (fluoro)kinoloni;
17170 Amer (Girona) SPAIN 
17170 Amer (Girona) ŠPANIJA
Hungary Ceva-Phylaxia Co. Ltd. Szállás u. 5. 
Madžarska Ceva-Phylaxia Co. Ltd. Szállás u. 5.
Scan Vet Poland Sp. z o.o. 
Scan Vet POLJSKA Sp. z o.o.
For 163 products the SPC warnings were not adequate because they do not contain all the prudent use warnings in section 4 of the SPC or warnings for fluoroquinolone were used instead of quinolone warnings, or vice versa. 
Pri 163 zdravilih opozorila v povzetkih glavnih značilnosti zdravila niso bila zadostna, ker v 4. poglavju ni bilo vseh opozoril o preudarni rabi ali pa ker so bila uporabljena opozorila za fluorokinolone namesto za kinolone ali obratno.
Hungary Orion Corporation Orionintie 1A 
Madžarska Orion Corporation Orionintie 1A
IBERIL - Soc. Comercial de Produtos Agro-Pecuários, Lda Praça Dr. Francisco Sá Carneiro, n.º 7-5º esquerdo 1000-159 Lisboa PORTUGAL 
Portugalska IBERIL - Soc. Comercial de Produtos Agro-Pecuários, Lda Praça Dr. Francisco Sá Carneiro, n.º 7-5º esquerdo 1000-159 Lisboa
88212 Ravensburg 
88212 Ravensburg NEMČIJA
Active substance(s) 
Zdravilna(e) učinkovina(e)
7323 Brande 
7323 Brande DANSKA
28031 Madrid SPAIN 
28031 Madrid ŠPANIJA
06516 Carros Cedex FRANCE 
06516 Carros Cedex FRANCIJA
La Selva 135 17170 Amer (Girona) SPAIN 
La Selva 135 17170 Amer (Girona) ŠPANIJA
Romania S.C. CRIDA PHARM S.R.L. 
Romunija S.C. CRIDA PHARM S.R.L.
33500 Libourne FRANCE 
33500 Libourne FRANCIJA
Romania Orion Corporation Orionintie 1A 
Romunija Orion Corporation Orionintie 1A
Vetlima - Soc. Distribuidora de Pro. Agro-Pecuários, Lda Avenida 5 Outubro 35, 3°-E 1050-047 Lisboa PORTUGAL 
Portugalska Vetlima - Soc. Distribuidora de Pro. Agro-Pecuários, Lda Avenida 5 Outubro 35, 3°-E 1050-047 Lisboa
831 02 Bratislava SLOVAK REPUBLIC 
831 02 Bratislava SLOVAŠKA
08950 Esplugues de Llobregat SPAIN 
08950 Esplugues de Llobregat ŠPANIJA
3421 GW Oudewater NETHERLANDS 
3421 GW Oudewater NIZOZEMSKA
08228 Tarrasa SPAIN 
08228 Tarrasa ŠPANIJA
A. For products listed in Annex I containing fluoroquinolones (enrofloxacin, marbofloxacin, danofloxacin and difloxacin): 
A. Za zdravila, navedena v Dodatku I, ki vsebujejo fluorokinolone (enrofloksacin, marbofloksacin, danofloksacin in difloksacin):
Laboratoires Biové 3 Rue de Lorraine, BP 45 62510 Arques FRANCE 
Laboratoires Biové 3 Rue de Lorraine, BP 45 62510 Arques FRANCIJA
Zone industrielle d'Etriche Route d'Avire, BP 103 49500 Segré Cedex FRANCE 
Zone industrielle d'Etriche Route d'Avire, BP 103 49500 Segré Cedex FRANCIJA
(MI) ITALY 
(MI) ITALIJA
Hungary Bayer Hungária Kft. Alkotás u. 50. 
Madžarska Bayer Hungária Kft. Alkotás u. 50.
• the use of (fluoro)quinolones in animals has selected for antimicrobial resistance in animal pathogens and food borne zoonotic pathogens; 
• uporaba (fluoro)kinolonov pri živalih je selekcionirala protimikrobno odpornost pri povzročiteljih bolezni živali in zoonotskih bolezenskih povzročiteljih, ki se prenašajo s hrano;
24-100 Puławy POLAND 
24-100 Puławy POLJSKA
96-100 Skierniewice POLAND 
96-100 Skierniewice POLJSKA
Naquilene 500 MP Premix For Medicated Feeding Stuff 
Naquilene 500 MP Premix For Medicated Feeding Stuff flumekvin
The fluoroquinolone products concerned contain the active substances enrofloxacin, marbofloxacin, danofloxacin and difloxacin, and the quinolone products contain flumequine and oxolinic acid. 
Zadevna zdravila s fluorokinoloni vsebujejo zdravilne učinkovine enrofloksacin, marbofloksacin, danofloksacin in difloksacin, zdravila s kinoloni pa flumekvin in oksolinsko kislino.
Bovine 
govedo
7 44153 Ancenis Cedex FRANCE 
7 44153 Ancenis Cedex FRANCIJA
88326 Aulendorf GERMANY 
6 - 8 88326 Aulendorf NEMČIJA
400064 Ozzano Emilia (BO) ITALY 
400064 Ozzano Emilia (BO) ITALIJA
Following a focus group meeting of the CVMP with Interested Parties and Member States, the CVMP adopted a 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) detailing the precautionary phrases to be included in the Summary of the Product Characteristics, as follows: 
Po sestanku ciljne skupine s CVMP in zainteresiranimi stranmi in državami članicami je CVMP sprejel razpravni dokument o uporabi fluorokinolonov pri živalih za proizvodnjo živil - previdnostni ukrepi v povzetku glavnih značilnosti zdravila s priporočili za preudarno rabo (EMEA/CVMP/416168/2006), ki vsebujejo podrobne previdnostne stavke, ki se vključijo v povzetek glavnih značilnosti zdravila, kakor sledi:
Romania Pharmaqua-D. Kokkoris and Bros 
Romunija Pharmaqua-D. Kokkoris and Bros
66-400 Gorzów Wielkopolski POLAND 
66-400 Gorzów Wielkopolski POLJSKA
The CVMP suggested that prudent use of fuoroquinolones should be strongly promoted through recommendations in the SPC and that there was a need to harmonise the prudent use instructions in the product literature of these products. 
CVMP je menil, da je treba skozi priporočila v povzetkih glavnih značilnosti zdravil strogo priporočati preudarno rabo kinolonov in da so potrebna usklajena navodila za preudarno rabo v literaturi za omenjena zdravila.
Subsequently, the European Commission invoked Community interest and referred all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species to the Agency in order to ensure that the warnings on prudent use included in the Summary of the Product Characteristics for these classes of products were harmonised in line with those recommended in the CVMP Reflection paper. 
Zato je zaradi interesa Skupnosti Evropska komisija vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo kinolone, vključno s fluorokinoloni, za uporabo pri živalskih vrstah za proizvodnjo živil napotila na agencijo, da se zagotovi, da so opozorila o preudarni rabi, ki so vključena v povzetek glavnih značilnosti zdravila, usklajena med zdravili te skupine ter v skladu s priporočili razpravnega dokumenta CVMP.
Solution Acide Oxolinique 5% Volailles Deltavit 
Solution Acide Oxolinique 5% Volailles Deltavit oksolinska kislina
Amendments to be included in the relevant sections of the summary of product characteristics 
Dopolnila, ki se vključijo v ustrezna poglavja povzetka glavnih značilnosti zdravila
1050 Brussels BELGIUM 
1050 Brussels BELGIJA
228.4 mg/ml (equivalent to 180 mg/ml Danofloxacin) 
228,4 mg/ml (enakovredno 180 mg/ml danofloksacina)
70204 Lure cedex FRANCE 
70204 Lure cedex FRANCIJA
Euro-Quin 10 % Powder for Oral Solution 
Euro-Quin 10 % Powder for Oral Solution flumekvin
Dzierżoniowska 21 58-260 Bielawa POLAND 
58-260 Bielawa POLJSKA
Flumequina 10%powder flumechina 10g/100g powder for use in drinking water 
Flumequina 10%powder flumechina 10g/100g powder for use in drinking water flumekvin
Flumiquil Comprimes De 1,010 g 
Flumiquil Comprimes De 1,010 g flumekvin
Romania Pfizer Animal Health Ramsgate Road 
Romunija Pfizer Animal Health Ramsgate Road
Romania Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona 
Romunija Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona
Industrial Veterinaria S.A. Esmeralda, 19 - 4º 08950 Esplugues de Llobregat SPAIN 
Industrial Veterinaria S.A. Esmeralda, 19 - 4º 08950 Esplugues de Llobregat ŠPANIJA
Flumequina 10%solution flumechina 10g/100g oral solution 
Flumequina 10%solution flumechina 10g/100g oral solution flumekvin
Scientific conclusions and grounds for amendment of the summary of product characteristics and package leaflet 
Znanstveni zaključki in podlaga za dopolnilo povzetka glavnih značilnosti zdravila in navodila za uporabo
Norway 
NORVEŠKA
Romania Kepro B.V. Maagdenburgstraat 38 7421 ZE Deventer NETHERLANDS 
Maagdenburgstraat 38 7421 ZE Deventer NIZOZEMSKA
3641 RT Mijdrecht THE NETHRLANDS 
3641 RT Mijdrecht NIZOZEMSKA
Further to the evaluation of all information made available to the Committee the following conclusions were made concerning the inclusion of prudent use warnings in the Summary of the Product Characteristics of the concerned products: 
V zvezi z oceno vseh informacij, ki jih je glede vključitve opozoril o preudarni rabi v povzetek glavnih značilnosti zdravila prejel Odbor, so bili sprejeti naslednji zaključki:
Amoxicillin Flumequine per 100 g: 
amoksicilin flumekvin na 100 g:
Divasa-Farmavic S.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) SPAIN 
Divasa-Farmavic S.A. Ctra San Hipolito km 71 08503 Gurb-Vic (Barcelona) ŠPANIJA
62-200 Gniezno POLAND 
62-200 Gniezno POLJSKA
Flumeq 50-S 500 mg/g Powder for use in drinking water /milk for cattle and chicken 
Flumeq 50-S 500 mg/g Powder for use in drinking water /milk for cattle and chicken flumekvin
Flumexil 5% Suspension For Injection 
Flumexil 5% Suspension For Injection flumekvin
300 mg/tablet 
300 mg/tableto tablete teleta
14451 Metamorfosi Attikis GREECE 
14451 Metamorfosi Attikis GRČIJA
Flumix Flumequine 160 Salmonides 
Flumix Flumequine 160 Salmonides flumekvin
Romania Industrial Veterinaria S.A. Esmeralda, 19 - 4º 
Romunija Industrial Veterinaria S.A. Esmeralda, 19 - 4º
Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona SPAIN 
Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona ŠPANIJA
1130 Brussels 
1130 Brussels BELGIJA
Denmark Ceva Santé Animale Zone Industrielle La Ballastiere 
Portugalska Ceva Santé Animale Zone Industrielle La Ballastiere
Flumival 10% Solution Orale Pour Volailles et Veaux 
Flumival 10% Solution Orale Pour Volailles et Veaux flumekvin
The Committee also noted that not all veterinary medicinal products containing quinolones including fluoroquinolones authorised in the EEA-EU have been included in the scope of the referral as either some products were not notified to the Agency by the competent national authorities or the information was not received on time to allow the inclusion of these products in the referral procedure. 
Odbor je ugotovil tudi, da vsa v EGP-EU odobrena zdravila za uporabo v veterinarski medicini, ki vsebujejo kinolone, vključno s fluorokinoloni, niso bila vključena v obseg napotitve, saj pristojni nacionalni organi agenciji niso prijavili določenih zdravil ali pa informacije niso bile prejete pravočasno za vključitev omenjenih zdravil v napotitev.
With regard to 132 products no information was submitted by the Applicants/Marketing Authorisation Holders or competent national authorities and therefore an assessment of the concerned Summary of the Product Characteristics could not be made. 
Za 132 zdravil predlagatelji/imetniki dovoljenj za promet z zdravilom ali pristojni nacionalni organi niso predložili podatkov, zato ni bila možna ocena zadevnih povzetkov glavnih značilnosti zdravila.
288 02 Nymburk CZECH REPUBLIC 
Zámečnícka 411 288 02 Nymburk ČEŠKA
ROMANIA 
ROMUNIJA
Imequyl 10% 100mg/g powder for use in drinking water/milk for cattle, chicken and tureky 
Imequyl 10% 100mg/g powder for use in drinking water/milk for cattle, chicken and tureky flumekvin
• precautionary phrases related to the use of (fluoro)quinolones intended for food-producing species have been included in Summary of the Product Characteristics for 163 products which however do not adequately reflect the CVMP recommendations; 
• previdnostni stavki v zvezi z uporabo (fluoro)kinolonov pri živalih za proizvodnjo živil v povzetkih glavnih značilnosti 163 zdravil niso zadostno odražali priporočil CVMP;
HIPRALONA ENRO-I, injekcinis tirpalas galvijams ir kiaulėms 
HIPRALONA ENRO-I, injekcinis tirpalas galvijams ir kiaulėms govedo prašiči intramuskular no
Diflocin 10 % oral solution 
Diflocin 10 % oral solution difloksacin
Flumix Flumequine 24 Lapin-Volaille 
Flumix Flumequine 24 Lapin-Volaille flumekvin
ACROLIN 10, solução oral para frangos de carne 
ACROLIN 10, solução oral para frangos de carne peroralna raztopina piščanci
In addition the Committee notes that the list of products in Annex I does not include all veterinary medicinal products containing quinolones including fluoroquinolones authorised in the EEA-EU, as either some products were not notified to the Agency by the competent national authorities or the information was not received in time to include these products in the current referral. 
Poleg tega je Odbor ugotovil, da seznam zdravil v Dodatku I ne vključuje vseh v EGP-EU odobrenih zdravil za uporabo v veterinarski medicini, ki vsebujejo kinolone, vključno s fluorokinoloni, saj pristojni nacionalni organi agenciji določenih zdravil niso prijavili ali pa informacije niso bile prejete pravočasno za vključitev omenjenih zdravil v to napotitev.
JORDANIA 
JORDANIJA
Quinolone products1 (e.g. flumequine, oxolinic acid) 
Zdravila s kinoloni1 (npr. flumekvin, oksolinska kislina)
VIRBAC ESPAÑA, S.A. Angel Guimera, 179-181 08950 Esplugues de Llobregat SPAIN 
Angel Guimera, 179-181 08950 Esplugues de Llobregat ŠPANIJA
Camí Pedra Estela S/N 43205 Reus SPAIN 
Camí Pedra Estela S/N 43205 Reus ŠPANIJA
Flumiquil 50% oral powder for chicken, tureky, pig, cattle, sheep, trout and eel 
Flumiquil 50% oral powder for chicken, tureky, pig, cattle, sheep, trout and eel flumekvin
Pfizer Ltd Ramsgate Road Sandwich Kent 
Bolgarija Pfizer Ltd Ramsgate Road Sandwich
Laboratorios Syva, S.A. Parroco Pablo Diez, 49-57 24010 Trobajo Del Camino SPAIN 
Laboratorios Syva, S.A. Parroco Pablo Diez, 49-57 24010 Trobajo Del Camino ŠPANIJA
4941 VX Raamsdonksveer NETHERLANDS 
4941 VX Raamsdonksveer NIZOZEMSKA
Lithuania Industrial Veterinaria S.A. Esmeralda, 19 - 4º 
Bolgarija Industrial Veterinaria S.A. Esmeralda, 19 - 4º
Flumix Flumequine 48 Porc 
Flumix Flumequine 48 Porc flumekvin
• 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; 
• primerni previdnostni stavki v zvezi z uporabo (fluoro)kinolonov pri živalih za prehrano ljudi so bili v povzetkih glavnih značilnosti 318 zdravil, ki bili so zajeti v to napotitev;
T. Skretting A/S P.O. 
Norveška T. Skretting A/S P.O. Box 319
Flubactin 20%, 200mg/ml oral solution for cattle, sheep, chicken, pig, mink, coypu and rabbit 
Flubactin 20%, 200mg/ml oral solution for cattle, sheep, chicken, pig, mink, coypu and rabbit flumekvin
Enrofloxacin Colistin sulphate Vitamin C 
Enrocol enrofloksacin kolistin sulfat vitamin C
SLOVENIA 
SLOVENIJA
Romania CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus 
Romunija CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
Advocine Poudre Orale Danofloxacin 0.1667 g 
Advocine Poudre Orale danofloksacin 0,1667 g peroralni prašek piščanci pitovni piščanci
Germany Calluna Pharma bvba Lindendreef 16 box 4 
Calluna Pharma bvba Lindendreef 16 box 4 2320 Hoogstraten BELGIJA
5 mg/tablet 
5 mg/tableto tablete perutnina
1161 Budapest HUNGARY 
1161 Budapest MADŽARSKA
Veterinary medicinal products containing all the correct prudent use warnings in section 4 of the SPC (Special precautions for use), exactly as the CVMP recommendation and veterinary medicinal products containing all the prudent use warnings in section 4 of the SPC, which is however not exactly the text recommended by the CVMP, but conveys the same key messages; Group 2. 
Zdravila za uporabo v veterinarski medicini, ki vsebujejo vsa pravilna opozorila o preudarni rabi v 4. poglavju povzetka glavnih značilnosti zdravila (Posebni previdnostni ukrepi), ki natančno posnemajo priporočila CVMP, in zdravila za uporabo v veterinarski medicini, ki vsebujejo vsa opozorila o preudarni rabi v 4. poglavju povzetka glavnih značilnosti zdravila, vendar ne posnemajo natančno priporočenega besedila CVMP, vsekakor pa izražajo enaka ključna sporočila; Skupina 2.
Lithuania Laboratorios Calier, S.A. Barcelonés, 26 
Bolgarija Laboratorios Calier, S.A. Barcelonés, 26
57.5 mg/g 
57,5 mg/g prašek govedo
Amendments to be included in the relevant sections of the package leaflet 
Dopolnila, ki se vključijo v ustrezna poglavja navodila za uporabo
Hungary Ascor Chimici S.r.l. 
Madžarska Ascor Chimici S.r.l.
Hungary Chanelle Pharmaceuticals Manufacturing Limited IDA Business & Technology Park 
Madžarska Chanelle Pharmaceuticals Manufacturing Limited IDA Business & Technology Park
Flumisol 100mg/ml oral solution for chicken, tureky, pig, cattle and sheep 
Flumisol 100mg/ml oral solution for chicken, tureky, pig, cattle and sheep flumekvin
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. 
Zdravila za uporabo v veterinarski medicini, ki vsebujejo opozorila o preudarni rabi v 4. poglavju povzetka glavnih značilnosti zdravila, vendar ne odražajo ustrezno priporočil CVMP; Skupina 3.
FLUYESYVA suspensão injectável 
FLUYESYVA suspensão injectável flumekvin
Alsir Lechones Solucion Oral 
Alsir Lechones Solucion Oral peroralna raztopina pujski
2630 Aartselaar BELGIUM 
Kontichsesteenweg 42 2630 Aartselaar BELGIJA
Flumequine 
flumekvin
Biovet AD 39 Petar Rakov Str. 4550 Peshtera BULGARIA 
Bolgarija Biovet AD 39 Petar Rakov Str.
Flumisol Drinkable Solution 
Flumisol Drinkable Solution flumekvin
Drinkmix flumequine Flumequine 
Drinkmix flumequine flumekvin
Enrofloxacin 10% Enrofloxacin 10% 
Enrofloxacin 10% enrofloksacin 10 %
Acide Oxolinique 30 Volaille Franvet 
Acide Oxolinique 30 Volaille Franvet oksolinska kislina
Fluyesyva Inyectable Flumequine 
Fluyesyva Inyectable flumekvin
ENROBIOFLOX 10 % (w/v) perorální roztok 
ENROBIOFLOX 10 % (w/v) perorální roztok peroralna raztopina piščanci teleta prašiči
Flumesyva Oral paste Flumequine 
Flumesyva Oral paste flumekvin
Flumisol Oral Solution 100mg/ml 
Flumisol Oral Solution 100mg/ml flumekvin
Kenflox 20% Oral 
Kenflox 20% Oral peroralna raztopina perutnina
Romania Divasa-Farmavic S.A. Ctra San Hipolito km 71 
Romunija Divasa-Farmavic S.A. Ctra San Hipolito km 71
Vétoquinol B.V. 
Nizozemska Vétoquinol B.V.
Schippers Europe B.V. Bleijenhoek 17 
Nizozemska Schippers Europe B.V.
Acide Oxolinique 60 Porc Franvet 
Acide Oxolinique 60 Porc Franvet oksolinska kislina
ICC-O-Flu 50% Flumequine 
ICC-O-Flu 50% flumekvin
Rabbits Fur animals 
Živalska vrsta
Danofloxacin mesilate per ml: danofloxacin mesylate 31,73 mg equivalent to danofloxacin 25 mg 
Advocin solution for injection danofloksacin mesilat v vsakem ml: 31,73 mg danofloksacin mesilata, enakovredno 25 mg danofloksacina govedo prašiči intramuskular no, intravensko
Flumesyva Pasta Oral 
Flumesyva Pasta Oral flumekvin
Hungary Divasa-Farmavic S.A. Ctra San Hipolito km 71 
Madžarska Divasa-Farmavic S.A. Ctra San Hipolito km 71
PM 35 Acide Oxolinique 80 Porc 
PM 35 Acide Oxolinique 80 Porc oksolinska kislina
Flumix 50% super WO Flumequine 
Flumix 50% super WO flumekvin
Inoxyl Acide Oxolinique 240 Salmonides 
Inoxyl Acide Oxolinique 240 Salmonides oksolinska kislina
Baytril 25 mg/ml Lösung zum Eingeben für Kälber 
Baytril 25 mg/ml Lösung zum Eingeben für Kälber peroralna raztopina teleta
Flumesyva Premezcla Flumequine 
Flumesyva Premezcla flumekvin
Enrofloxan 10% solution, enrofloksacyna 100mg/ml Solution for use in drinking water/milk for pig, chicken and pigeons 
Enrofloxan 10% solution, enrofloksacyna 100mg/ml Solution for use in drinking water/milk for pig, chicken and pigeons peroralna raztopina piščanci prašiči golobi
BAYTRILâ ORALE 0,5% sol 
BAYTRILâ ORALE 0,5% sol peroralna raztopina pujski
08017 Barcelona SPAIN 
08017 Barcelona ŠPANIJA
Ganadil Flumequina Polvo Oral 
Ganadil Flumequina Polvo Oral flumekvin
FLUBACTIN, geriamasis tirpalas 
FLUBACTIN, geriamasis tirpalas flumekvin
ENROXIL 100 mg/ml, geriamasis tirpalas paukščiams 
ENROXIL 100 mg/ml, geriamasis tirpalas paukščiams peroralna raztopina perutnina
Farmavet OOD 40 Otec Paisij Str. 9700 Shumen BULGARIA 
Bolgarija Farmavet OOD 40 Otec Paisij Str.
Eurovet Animal Health B.V. Handelsweg 25 
Nizozemska Eurovet Animal Health B.V.
Quinoex 10 oral solution 
Quinoex 10 oral solution peroralna raztopina perutnina
Bruistensingel 310 5232 AE Den Bosch THE NETHRLANDS 
5232 AE Den Bosch NIZOZEMSKA
FLUMAX 50 %, geriamieji milteliai 
FLUMAX 50 %, geriamieji milteliai flumekvin
Ganadexil enrofloxacina 0,5 % oral pump 
Ganadexil enrofloxacina 0,5 % oral pump peroralna raztopina prašiči
Enrofloxacin Bromhexine 
Bromeflox enrofloksacin bromheksin
Marbocyl 2 % Marbofloxacin 2% 
Marbocyl 2 % marbofloksacin 2 %
Romania Ascor Chimici S.r.l. 
Romunija Ascor Chimici S.r.l.
Authorisation Holders or competent national authorities and for which no assessment of the existing SPC warnings was therefore possible. 
Zdravila, za katera predlagatelji/imetniki dovoljenj za promet z zdravilom ali pristojni nacionalni organi niso predložili podatkov, zato ni bila možna ocena obstoječih opozoril v povzetku glavnih značilnosti zdravila.
Baytril piglet 25 mg/ml 
Baytril piglet 25 mg/ml prašiči intramuskular no
Enrofloxacin No information available 
Floxabactin enrofloksacin ni razpoložljivih podatkov ni razpoložljivih podatkov ni razpoložljivih podatkov ni razpoložljivih podatkov
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. 
Predlagatelji/imetniki dovoljenj za promet z zdravilom in pristojni nacionalni organi so predložili povzetke glavnih značilnosti zdravila za 564 od 696 zdravil, vključenih v napotitev.
Hungary S.P. Veterinaria S.A. Ctra. 
Madžarska S.P. Veterinaria S.A. Ctra.
Poultry (chickens and turkeys) 
peroralna raztopina perutnina (piščanci in purani)
HUNGARY 
Madžarska
Bulgaria 
BOLGARIJA
UNISOL 2.5% oral solution for calves 
UNISOL 2.5% oral solution for calves peroralna raztopina teleta
No information available 
prašiči govedo ni razpoložljivih podatkov
Oxomid Acide Oxolinique 240 Salmonides 
Oxomid Acide Oxolinique 240 Salmonides oksolinska kislina
Marbocyl 2% w/v Solution for Injection 
Marbocyl 2% w/v Solution for Injection marbofloksacin 2 %
Zámečnícka 411 
Bruistensingel 310
Enflocyna SOL 50mg/ml oral solution for cattle, pig, dog, chicken, tureky and pigeons 
Enflocyna SOL 50mg/ml oral solution for cattle, pig, dog, chicken, tureky and pigeons peroralna raztopina govedo prašiči psi piščanci golobi purani
FLUMECHINA 50 %, geriamasis tirpalas 
FLUMECHINA 50 %, geriamasis tirpalas flumekvin
Floxavex 100 mg/ml Concentrado Para Solucion oral pollos Y pavos 
Floxavex 100 mg/ml Concentrado Para Solucion oral pollos Y pavos koncentrat za peroralno raztopino perutnina, purani
08028 Barcelona SPAIN 
08028 Barcelona ŠPANIJA
FLUBACTIN sol 
FLUBACTIN sol flumekvin
KARIFLOX 5 mg/ml oral solution for piglets 
KARIFLOX 5 mg/ml oral solution for piglets peroralna raztopina pujski
Flumix Poudre A 3 % Flumequine 
Flumix Poudre A 3 % flumekvin
Cofoxyl Liquide 
Cofoxyl Liquide oksolinska kislina
Laboratorios Syva, S.A. arroco Pablo Diez, 49-57 24010 Trobajo Del Camino SPAIN 
Laboratorios Syva, S.A. arroco Pablo Diez, 49-57 24010
Inoxyl Solution Buvable Oxolinic acid 50 mg 
Inoxyl Solution Buvable oksolinska kislina
Marbocyl 10% Marbofloxacin 10% 
Marbocyl 10% marbofloksacin 10 %
GERMANY 
Nemčija