Colistin Oral
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Annex I List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, applicants/marketing authorisation holders in the Member States 1/64 Member Applicant/Marketing Pharmaceutical State Product name INN Strength Animal species authorisation holder form EU/EEA Austria Alvetra & Werfft GmbH Bioplex Colistin 25 mg/g - Pulver Colistin (as 25 mg/g Powder for use Calves, pigs, chickens Boltzmanngasse 11, zum Eingeben für Rinder, sulphate) in food, drinking 1090 Wien, Schweine, Hühner water or milk Austria Austria Animed Service AG Colistin-Enteromix - Pulver zum Colistin (as 25 mg/g Powder for use Calves, pigs, chickens Liebochstrasse 9, Eingeben für Tiere sulphate) in food, drinking 8143 Dobl, water or milk Austria Austria Animed Service AG Colistinsulfat PUR "AniMed Colistin (as 1 g/g Powder for use Calves, pigs, chickens Liebochstrasse 9, Service" 1 g/g - Pulver zum sulphate) in drinking water 8143 Dobl, Eingeben für Tiere Austria Austria Animed Service AG Colixid 25 mg/g - Pulver zum Colistin (as 25 mg/g Powder for use Pigs (piglets and pigs Liebochstrasse 9, Eingeben für Schweine sulphate) in feed <40 kg) 8143 Dobl, Austria Austria aniMedica GmbH Colistinsulfat 1000 mg/g Colistin (as 1000 mg/g Powder for use Calves, pigs, chickens Im Südfeld 9, "aniMedica" - Pulver zum sulphate) in drinking water 48308 Senden-Bösensell, Eingeben für Rinder, Schweine Germany und Hühner Austria Ceva Sante Animale COLIVET 2 000 000 IU/ml Colistin (as 2 000 000 IU Concentrate for Pigs, poultry La Ballastière, Konzentrat für eine orale Lösung sulphate) oral solution 33501 Libourne, für Schweine und Geflügel France Austria Chevita Tierarzneimittel Sabaco Colistin 120 mg/g - Colistin (as 120 mg/g Powder for use Calves, pigs, chickens GmbH Pulver zum Eingeben für Tiere sulphate) in food, drinking Kaplanstraße 10, water or milk 4600 Wels, Austria 2/64 Member Applicant/Marketing Pharmaceutical State Product name INN Strength Animal species authorisation holder form EU/EEA Austria OGRIS Pharma Vertriebs- Colistinsulfat 120 mg/g "Ogris" - Colistin (as 120 mg/g Powder for use Calves, pigs, chickens GmbH Pulver zum Eingeben für Tiere sulphate) in food, drinking Hinderhoferstraße 3, water or milk 4600 Wels, Austria Austria OGRIS Pharma Vertriebs- Enteroxid "Ogris" 25 mg/g, Colistin (as 25 mg/g Powder for use Pigs (piglets and pigs GmbH Pulver zum Eingeben für sulphate) in feed <40 kg) Hinderhoferstraße 3, Schweine 4600 Wels, Austria Belgium Divasa-Farmavic, S.A. Coliplus 2 000 000 UI/ml Colistin 2 000 000 IU/ml Concentrate for Cattle (calves), sheep Ctra. Sant Hipòlit, km 71 oral solution for (lambs), pigs and PO Box 79 use in drinking chickens 08503 GURB-VIC water Spain Belgium EMDOKA bvba Emdocolin 10% Colistin 100 mg/g Powder for oral Calves and pigs John Lijsenstraat 16 solution B-2321 Hoogstraten Belgium Belgium EMDOKA bvba Emdocolin 50% Colistin 500 mg/g Powder for oral Calves and pigs John Lijsenstraat 16 solution B-2321 Hoogstraten Belgium Belgium EMDOKA bvba Emdocolin Tabs Colistin 121.56 mg Tablet Non-ruminating John Lijsenstraat 16 (equivalent to calves B-2321 Hoogstraten 3 000 000 IU) Belgium 3/64 Member Applicant/Marketing Pharmaceutical State Product name INN Strength Animal species authorisation holder form EU/EEA Belgium Eurovet N.V. Colistine Eurovet 400 000 IU/ml Colistin 400 000 IU/ml Concentrate for Non-ruminating Poorthoevestraat 4 oral solution for calves, pigs 3550 Heusden-Zolder use in drinking Belgium water or milkreplacer Belgium Eurovet N.V. Colistinemix 1 200 000 IU/g Colistin 1 200 000 IU/g Powder for oral Non-ruminating Poorthoevestraat 4 solution calves, pigs 3550 Heusden-Zolder Belgium Belgium KELA LABORATORIA NV Colistimax 1200 Colistin 1 200 000 IU/g Powder for oral Non-ruminating Sint Lenaartseweg 48 solution calves, piglets 2320 Hoogstraten Belgium Belgium Prodivet pharmaceuticals Colivet Bolus Colistin 150 mg Tablet for oral Non-ruminating sa/nv administration calves Hagbenden 39c B-4731 Eynatten Belgium Belgium Prodivet pharmaceuticals Colivet Quick Pump Colistin 8 mg/ml Oral suspension Piglets sa/nv Hagbenden 39c B-4731 Eynatten Belgium Belgium VMD N.V. Promycine 200 IU/mg Colistin 200 000 IU/g Premix for Chicken, pigs Hoge Mauw 900 medicated 2370 Arendonk feedingstuff Belgium 4/64 Member Applicant/Marketing Pharmaceutical State Product name INN Strength Animal species authorisation holder form EU/EEA Belgium VMD N.V. Promycine 400 IU/mg Colistin 400 000 IU/g Premix for Pigs Hoge Mauw 900 medicated 2370 Arendonk feedingstuff Belgium Belgium VMD N.V. Promycine Bolus 3 MIO IE Colistin 3 000 000 IU Tablet Non-ruminating Hoge Mauw 900 calves 2370 Arendonk Belgium Belgium VMD N.V. Promycine Pulvis 1000 IE/mg Colistin 1 000 000 IU/g Powder for oral Non-ruminating Hoge Mauw 900 solution calves, pigs, poultry 2370 Arendonk Belgium Belgium VMD N.V. Promycine Pulvis 4800 IE/mg Colistin 4 800 000 IU/g Powder for oral Non ruminating Hoge Mauw 900 solution calves, pigs, poultry 2370 Arendonk Belgium Belgium aniMedica Espana S.L.U. Pluscolan Colistin 5 000 000 IU/ml Concentrate for Cattle (calves), pigs, Esmeralda 19 sulphate oral solution sheep (lambs) and 08950 Esplugues de poultry Liobregat (Barcelona) Spain Belgium Sogeval Sogecoli 2 000 000 IU/ml Colistin 2 000 000 IU/ml Concentrate for Calves, lambs, pigs, 200 Avenue de Mayenne Colistin 2 MIU/ml oral solution poultry Zone Industrielle des Touches 53000 Laval France 5/64 Member Applicant/Marketing Pharmaceutical State Product name INN Strength Animal species authorisation holder form EU/EEA Bulgaria Andersen S.A. НИПОКСИМ 40 премикс Colistin 1 200 000 IU/g Premix for Pigs, poultry, rabbits Avda. La Llana 123 sulphate medicated Poligono Industrial "La feedingstuff Llana" 08191 RUBI Barcelona Spain Bulgaria Andersen S.A. НИПОКСИМ 100 Colistin 3 000 000 IU Watersoluble Pigs, poultry, Avda. La Llana 123 sulphate oral powder suckling calves Poligono Industrial "La Llana" 08191 RUBI Barcelona Spain Bulgaria Andersen S.A. NIPOXYME 200 mg/g ОРАЛНА Colistin 200 mg/g Oral suspension Pigs (after weaning, Avda. La Llana 123 СУСПЕНЗИЯ sulphate also for fattening Poligono Industrial "La pigs) Llana" 08191 RUBI Barcelona Spain Bulgaria Andersen S.A. NIPOXYME 1000 mg/g Colistin 1000 mg/g Oral powder Pigs Avda. La Llana 123 перорален прах sulphate Poligono Industrial "La Llana" 08191 RUBI Barcelona Spain Bulgaria Ceva Sante Animale КОЛИВЕТ ПЕРОРАЛЕН РАЗТВОР Colistin 2 M IU/ml Oral solution Pigs, poultry (broilers 10 avenue de La Ballastiere sulphate and laying hens) 33500 Libourne Cedex France Bulgaria Ceva Sante Animale КОЛИВЕТ ПРЕМИКС Colistin 12 g Premix for Pigs, poultry 10 avenue de La Ballastiere sulphate medicated (chicken-broilers, 33500 Libourne Cedex feedingstuff laying hens and France breeders, turkeys), rabbits 6/64 Member Applicant/Marketing Pharmaceutical State Product name INN Strength Animal species authorisation holder form EU/EEA Bulgaria Ceva Sante Animale КОЛИВЕТ прах за перорална Colistin 1.2 M IU/g Oral powder Pigs, calves, poultry 10 avenue de La Ballastiere употреба sulphate 33500 Libourne Cedex France Bulgaria Farma SIS OOD ХИДРО КОЛИСТИН Colistin 2 000 000 IU/ml Oral solution Poultry, pigs 4 San Stefano str. sulphate Dobrich Bulgaria Bulgaria Farma SIS OOD КОЛИСИС ПРЕМИКС Colistin 10 g/100 g Premix Pigs 4 San Stefano str. sulphate Dobrich Bulgaria Bulgaria Gabropharm OOD КОЛИКРИД-БГ Colistin 2 000 000 IU/ml Oral solution Pigs, poultry 16 Alei Vazrajdane str., sulphate app. 42 Russe 7200 Bulgaria Bulgaria V.M.D. n.v. ПРОМИЦИН-4800 Colistin 4 800 000 IU/g Oral powder Pigs, calves Hoge Mauw 900 sulphate B-2370 Arendonk Belgium Bulgaria BIOSFERA FARM Ltd. COLIDEM-BIO 50 Colistin 500 mg/ g Powder for oral Poultry, pigs 50 Yurii Gagarin str., sulphate use Kostinbrod Bulgaria 7/64 Member Applicant/Marketing Pharmaceutical State Product name INN Strength Animal species authorisation holder form EU/EEA Bulgaria DIVASA - FARMAVIC, S.A. Coliplus 2 000 000 IU/ml Colistin 2 M IU/ml Concentrate for Calves, lambs, pigs Ctra. Sant Hipolit, km 71, концентрат за перорален sulphate oral solution and chickens 08503 GURB - VIC, разтвор за прилагане в Barcelona питейна вода за говеда, овце, Spain свине и пилета Bulgaria Zavet Колистин 48 водоразтворим Colistin 4 800 000 IU/g Oral powder Calves, pigs Kiril and Metodiy str. 5 прах sulphate Zavet 7330 Bulgaria Croatia ARNIKA VETERINA d.o.o., DRINKMIX COLISTIN Colistin 5 million IU/g Powder for oral Calves, pigs, poultry Vidikovac 20, sulphate solution 1000 Zagreb, Croatia Croatia Krka - Farma d.o.o., GIRAXA Colistin 50 mg/g Powder for oral Calves, pigs, poultry Radnička cesta 48, sulphate (1.2 million IU/g) solution 10000 Zagreb, Croatia Croatia VET CONSULTING d.o.o. , COLIVETo-4800S Colistin 4.8 million IU/g Powder for oral Calves, pigs, poultry Matije Gupca 42, sulphate solution 43500 Daruvar, Croatia Cyprus CEVA SANTE ANIMALE, COLIVET 2.000.000 IU/ml Colistin (as 2 000 000 IU/ml Oral solution Pigs, poultry Z.I. La Ballastiere sulphate) 33500 Libourne France 8/64 Member Applicant/Marketing Pharmaceutical State Product name INN Strength Animal species authorisation holder form EU/EEA Czech Andrés Pintaluba, S.A. APSAMIX COLISTINA 40 mg/g Colistin (as 40 mg/g Pre-mix for Pigs (piglets and Republic Polígono Industrial Agro- premix pro medikaci krmiva pro sulphate) (1 200 000 IU/g) medicated fattening pigs) Reus prasata feedingstuffs C/Prudenci Bertrana n 5, 43206 REUS (Tarragona) Spain Czech Bioveta, a. s. BIOVETA COLISTIN 1 200 000 Colistin 1 200 000 IU/g Powder for oral Piglets, calves, Republic Komenského 212 IU/mg prášek pro přípravu sulphate solution chicken (broilers) 683 23 Ivanovice na Hané perorálního roztoku Czech Republic Czech Ceva Animal Health COLIVET prášek pro přípravu Colistin (as 1 200 000 IU/g Powder for oral Calves, piglets, Republic Slovakia spol.