Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016 (2016/C 312/02)

Transcription

1 C 312/10 EN Official Journal of the European Union Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC ( 1 ) or Article 38 of Directive 2001/82/EC ( 2 )) (2016/C 312/02) Issuing, maintenance or modification of a national marketing authorization Date of the decision Name(s) of the medicinal product INN (International Non- Proprietary Name) Holder(s) of the marketing authorization Member State concerned Date of notification Saizen (and associated names) and Humatrope (and associated names) somatropin Not applicable Not applicable Revocation of a national marketing authorization Date of the decision Name(s) of the medicinal product INN (International Non- Proprietary Name) Holder(s) of the marketing authorization Member State concerned Date of notification Colistin combinations colistin See Annex I See Annex I ( 1 ) OJ L 311, , p. 67. ( 2 ) OJ L 311, , p. 1.

2 EN Official Journal of the European Union C 312/11 ANNEX List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, and marketing authorisation holders in the Member States Bulgaria Farma vet Ltd 40 Otec Paisii str. Shumen Bulgaria Колитетравит/COLI TET- RAVIT Oxytetracycline hydrochloride 5,0 g UI Chickens and pigs administration Bulgaria COOPHAVET S.A.S. B.P. 7 Saint Herblon ANCENIS Cedex Колисултрикс/COLISULTRIX Trimethoprim 3,75 g 50 MIU powder Chickens, rabbits, pigs, calves and lambs administration Croatia Arnika Veterina d.o.o. Vodovodna 20a Zagreb Croatia COLISULTRIX Trimethoprim 3,75 g 50 MIU powder Calves, lambs, kids, piglets, poultry and rabbits Croatia Ceva Santé Animale 10 Avenue de la Ballastière Libourne QUINOCOL Enrofloxacin 100 g 41,67 g Chicken, turkey Cyprus FATRO S.p.A. Via Emilia, Ozzano Emilia (Bologna) BACOLAM powder for oral for calves, sheep, goats, pigs, foals, chickens, turkeys (excluding layers) 100 mg I.U. Calves, sheep, goats, pigs, foals, chickens, turkeys (excluding layers) Administer the dose subdivided into two administrations each day, dissolved in drinking water or in milk.

3 C 312/12 EN Official Journal of the European Union Cyprus Vetoquinol Italia S.R.L Via Piana, Bertinoro ZEMAMIX premix for medicated ingstuff for pigs 11,48 g 4,00 g ingstuff Pigs ingstuff in insoluble powder, to be administered orally properly mixed in solid. Czech Republic LAVET Pharmaceuticals Ltd Ottó u Budapest Hungary AMOXYCOL plv.sol. 640 mg/g IU/g for in drinking water or in Pigs, chicken (broilers) Czech Republic COOPHAVET S.A.S. B.P. 7 Saint Herblon ANCENIS Cedex BELCOSPIRA ORAL prášek pro přípravu perorálního roztoku Spiramycin adipate IU IU Calves, piglets, foals, chicken Czech Republic COOPHAVET S.A.S. B.P. 7 Saint Herblon ANCENIS Cedex COLISULTRIX plv. sol. Trimethoprim 37,5 mg IU/g Chicken Czech Republic Industria Italiana Integratori Trei S.p.A. Via Corassori, Modena MICROAMOX COLI premix pro medikaci krmiva 100 mg/g IU/g Pigs

4 EN Official Journal of the European Union C 312/13 MERIAL 29 avenue Tony Garnier LYON BELCOSPIRA ORAL Spiramycin adipate IU/g IU/g Cattle, pigs, poultry LABORATOIRES BIOVE 3 Rue de Lorraine Arques COLAMPI B Ampicillin trihydrate 25 mg/g 0,075 MIU/g Pigs, calves LABORATOIRES BIOVE 3 Rue de Lorraine Arques COLAMPI O Ampicillin trihydrate 1 g/tablet 1 MIU/tablet Tablet Calves VETOQUINOL Magny Vernois Lure COLIDIARYL Erythromycin estolate IU/g IU/g Lamb, goat, piglets, foals, calves MERIAL 29 avenue Tony Garnier LYON COLISULTRIX POUDRE Trimethoprim IU/g 37,5 mg/g Lamb, goat, rabbits, pigs, calves, poultry VIRBAC 1ere Avenue 2065m L.I.D Carros Cedex ENTEROGEL 30 Scopolamine Sulfaguanidine 10,5 MIU/syringe 0,216 g/syringe 4,2 g/syringe paste Foals, calves

5 C 312/14 EN Official Journal of the European Union VIRBAC 1ere Avenue 2065m L.I.D Carros Cedex INTESTIVO Sulfaguanidine 2,5 MIU/tablet 1 g/tablet Tablet Lamb, goat, calve MERIAL 29 avenue Tony Garnier LYON N.P. 8 Neomycin sulfate IU/g IU/g Lamb, goat, rabbits, pigs, calves, poultry QALIAN 34 rue Jean Monnet ZI D Etiché BP Segré Cedex OXYCOLI Oxytetracycline hydrochloride IU/g 0,07 g/g Pigs, calves Ceva Santé Animale 10 Avenue de la Ballastière Libourne PHADILACT Ampicillin trihydrate 5,00 mg/g IU/g Lamb, goat, calves, poultry QALIAN 34 rue Jean Monnet ZI D Etiché BP Segré Cedex PRÉMELANGE MÉDICAMEN- TEUX CS FRANVET Sulfadimethoxine IU/g 210 mg/g Premix Lamb, calves VETOQUINOL Magny Vernois Lure SEPTOTRYL-COLISTINE Sulfamethoxypyridazine 2 MIU/tablet 1 g/tablet Tablet Lamb, dogs, foals, calves

6 EN Official Journal of the European Union C 312/15 Hungary Lavet Gyógyszergyártó Kft. Ottó u Budapest Hungary Amoxycol por belsőleges oldathoz A.U.V. 640,0 mg/g 133,3 mg/g Pigs, chickens In drinking water Hungary Industria Italiana Integratori Trei S.p.A. Viale Corassori, Modena BETAMICYN gyógypremix sertések részére A.U.V. 100 g/kg 600 MIU/kg Pigs In Hungary Rhone Vet Kft. Petőfi u Herceghalom Hungary Colisutrix belsőleges por Trimethoprim 3,75 g/100 g 50 MIU/100 g Cattle (calves), sheep (lambs), pigs and chickens, rabbit, goat In drinking water Fatro S.p.a. Via Emilia, Ozzano Emilia COMBOMIX 115 mg/g 40 mg/g Pigs, chickens (other than laying hens in lay) Industria Italiana Integratori Trei S.P.A. Via Affarosa, Rio Saliceto BETAMICYN 100 g/kg 600 MIU/kg Pigs Doxal Italia S.p.a. largo Donegani Milano CLOVER BMP 115 g/kg 40 g/kg Pigs

7 C 312/16 EN Official Journal of the European Union Industria Italiana Integratori Trei S.P.A. Via Affarosa, Rio Saliceto DUOBAN Doxycycline hyclate 60 mg/g UI/g Pigs, rabbits Virbac S.r.l. Via Caldera Milano DUALMIX 115 mg/g 4 mg/g ( UI/mg) Pigs, chickens (except hens producing eggs for human consumption) Fatro S.p.a. Via Emilia, Ozzano Emilia BACOLAM 500 mg/g IU/g Calves, sheep and goats, pigs, ponies, chickens, turkeys (excluding hens) Intervet Productions S.r.l. Via Nettunense, km 20, Aprilia NADASIN 500 mg/g 200 mg/g powder for in drinking water or liquid Calves, pigs, chickens (other than laying hens), turkeys Vetoquinol Italia S.r.l. Via Piana, Bertinoro NEOMIX COMPLEX Neomycin sulfate 200 mg/g IU/g powder, for in drinking water or liquid Calves, piglets, broilers and turkeys

8 EN Official Journal of the European Union C 312/17 Vétoquinol Italia S.r.l. Via Piana Bertinoro ZEMAMIX 100 mg/g 40 mg/g powder Pigs Virbac S.r.l. Via Caldera Milano STABOX COLI 100 mg/g IU/g ing Pigs, chickens (except hens producing eggs for human consumption) Latvia Ceva Santé Animale 10 Avenue de la Ballastière Libourne Quinocol Solution Enrofloxacin 100 g 41,67 g Solution for oral Chicken, turkeys Lithuania Lavet Pharmaceuticals Ltd Ottó u. 14. H-1161 Budapest Hungary AMOXYCOL, geriamieji milteliai 640 mg/ml IU/ml Water soluble oral Pig, chicken Lithuania COOPHAVET S.A.S. B.P. 7 Saint Herblon ANCENIS Cedex COLISULTRIX, geriamieji milteliai Trimethoprim 3,75 g/100 g 50 MIU/100 g powder Calves, lamb, kid, piglets, poultry and rabbits Lithuania COOPHAVET S.A.S. B.P. 7 Saint Herblon ANCENIS Cedex BELCOSPIRA ORAL, geriamieji milteliai Spiramycin adipate 65 MIU/100 g 50 MIU/100 g powder Calves, lamb, kid, foals, piglets, poultry and rabbits.

9 C 312/18 EN Official Journal of the European Union Luxembourg VETOQUINOL Magny Vernois Lure COLIDIARYL Erythromycin estolate UI/g UI/g Lamb, goat, piglets, foals, calves Luxembourg VETOQUINOL Magny Vernois Lure SEPTOTRYL-COLISTINE Sulfamethoxypyridazine 2 MIU/tablet 1 g/tablet Tablet Lamb, dogs, foals, calves Netherlands Dopharma B.V. Zalmweg VX Raamsdonksveer The Netherlands AMOXY-COL WSP 150 mg/g IU/g via drinking water Pigs, via drinking water Poland Dopharma B.V. Zalmweg VX Raamsdonksveer The Netherlands Amoxy-col WSP 150 mg/g IU/g Pigs Poland Fatro S.p.A. Via Emilia Ozzano Emilia Bacolam 100 mg/g IU/g Powder for administration in drinking water or milk Cattle, chickens, pigs Poland SkanVet Poland Sp. z o.o. Skiereszewo, ul. Kiszkowska Gniezno Poland Colamox 3200/ mg/g IU/g Chicken, pigs

10 EN Official Journal of the European Union C 312/19 Poland Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A ul. Grójecka Drwalew Poland Spiracol AD Spiramycin adipate IU/g IU/g Powder for in drinking water Cattle, chickens, pigs Portugal DIVASA FARMAVIC DE POR- TUGAL Produtos e Equipamentos Veterinários, Lda. Praceta Jaime Cortesão, No 1 R/C Loja Esq Póvoa de Santa Iria Portugal NUTRIVET TOTAL, pó para suspensão oral, para vitelos e cordeiros Ampicillin trihydrate 0,7 g IU suspension for administration in drinking water Calves and lambs Portugal VETLIMA-Sociedade Distribuidora de Produtos Agro-Pecuários, S.A. Centro Empresarial da Rainha, Lote Vila Nova da Rainha Portugal COLIMIX (116 g/kg/40 g/kg), pré-mistura medicamentosa para alimento medicamentoso para suínos 116 g/kg 40 g/kg Pigs Portugal Fatro S.p.A Via Emilia No 285 Ozzano Emilia Premaxol, 100 mg/g + 40 mg/ g de pré-mistura medicamentosa para alimento medicamentoso para suínos, frangos e galinhas (excepto poedeiras) 100 mg/g 40 mg/g Pigs and chickens (except laying)

11 C 312/20 EN Official Journal of the European Union Romania Industria Italiana Integratori Trei S.p.A Viale Corassori, Modena DUOBAN Doxycycline hyclate 60 mg/g IU/g Premix Pigs Mixed in ing stuffs Romania Industria Italiana Integratori Trei S.p.A Viale Corassori, Modena MICROAMOX COLI 100 mg/g IU/g Premix Pigs Mixed in ing stuffs Romania COOPHAVET SAS Herblon Ancenis COLISULTRIX Trimethoprim 37,5 mg IU Calves, lambs, kids, pigs, rabbits and poultry administration in drinking water or liquid Romania SC ROMVAC COMPANY SA Sos. Centurii nr Voluntari Romania GALIPROTECT C Oxytetracycline hydrochloride 12 mg/tablet 5 mg/tablet Tablets Poultry (gro and web-footed) administration individually Romania Lavet Pharmecuticals LTD. Otto u.14. H-1161 Budapest Hungary AMOXYCOL 640 mg/g IU/g Pigs, chickens administration in drinking water

12 EN Official Journal of the European Union C 312/21 Slovakia Pharmagal spol. s.r.o. Murgašova Nitra Slovakia Slovakia Pharmagal spol. s.r.o. Murgašova Nitra Slovakia Slovakia Pharmagal spol. s.r.o. Murgašova Nitra Slovakia Slovakia Pharmagal spol. s.r.o. Murgašova Nitra Slovakia Slovakia Pharmagal spol. s.r.o. Murgašova Nitra Slovakia Spain CENAVISA, S.A. Camí Pedra Estela s/n. Reus (Tarragona) Spain Spain LABORATORIOS MAYMO, S. A. Via Augusta, 302. Barcelona Spain Amikol perorálny prášok Amikol premix na medikáciu krmiva Amikol-S prášok na perorálny roztok SUTRICOL prášok na perorálny roztok TETRAKOL prášok na perorálny roztok Sulfadimidine sodium Trimethoprim Chlortetracycline hydrochloride TRISOL Ampicillin trihydrate COLIPHUR / UI/ml solución para administración en agua de bebida Neomycin sulfate 57,5 mg/g 8,1 mg/g 57,5 mg/g IU/g 575 mg/g 81 mg/g IU/g 50 mg/g 12,5 mg/g 120 mg/g IU/g 200 mg/g IU/g IU/ml IU/ml powder Pig, calves, poultry (chicken, turkey), pigeon administration, after incorporation into the Pig administration, after incorporation into the Pig, calves, poultry (chicken, turkey), pigeon Broiler chicken, pig, rabbit, calve Pig, calves, poultry (chicken) administration via drinking water administration via drinking water administration via drinking water powder Lambs In drinking water Solution for in drinking water Pig for fattening In drinking water