EN Official Journal of the European Union C 282/6

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2013 to 31 August 2013

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )

2013/C 282/02

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 12.8.2013 Soludox See Annex I See Annex I 13.8.2013 12.8.2013 STRENZEN See Annex II See Annex II 14.8.2013

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

ANNEX I LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder Name INN Pharmaceutical form Strength Animal species Route of administration Austria Eurovet Animal Health BV Handelsweg 25 5531 AE Bladel The Netherlands Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine und Hühner doxycycline hyclate Powder for use in drinking water 500 mg/g Pigs and chickens Oral: In drinking water Czech Republic Eurovet Animal Health BV Handelsweg 25 5531 AE Bladel The Netherlands Soludox 500 mg/g prášek pro podání v pitné vodě pro prasata doxycycline hyclate Powder for use in drinking water 500 mg/g Pigs and chickens Oral: In drinking water Estonia Eurovet Animal Health BV Handelsweg 25 5531 AE Bladel The Netherlands Soludox 500 mg/g suukaudse lahuse pulber sigadele ja kanadele doxycycline hyclate Powder for use in drinking water 500 mg/g Pigs and chickens Oral: In drinking water Finland Eurovet Animal Health BV Handelsweg 25 5531 AE Bladel The Netherlands Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi sioille ja kanoille doxycycline hyclate Powder for use in drinking water 500 mg/g Pigs and chickens Oral: In drinking water France Eurovet Animal Health BV Handelsweg 25 5531 AE Bladel The Netherlands Soludox 433 mg/g poudre pour administration dans l'eau de boisson des porcs et des poulets doxycycline hyclate Powder for use in drinking water 500 mg/g Pigs and chickens Oral: In drinking water Germany Eurovet Animal Health BV Handelsweg 25 5531 AE Bladel The Netherlands Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine und Hühner doxycycline hyclate Powder for use in drinking water 500 mg/g Pigs and chickens Oral: In drinking water Greece Eurovet Animal Health BV Handelsweg 25 5531 AE Bladel The Netherlands Soludox 500 mg/g υπό μορφή σκόνης για χρήση σε πόσιμο νερό για χοίρους και κοτόπουλα doxycycline hyclate Powder for use in drinking water 500 mg/g Pigs and chickens Oral: In drinking water Italy Eurovet Animal Health BV Handelsweg 25 5531 AE Bladel The Netherlands Soludox 500 mg/g polvere da somministrare nell’acqua da bere per suini e polli doxycycline hyclate Powder for use in drinking water 500 mg/g Pigs and chickens Oral: In drinking water Italy Eurovet Animal Health BV Handelsweg 25 5531 AE Bladel The Netherlands Acquadox 500 mg/g polvere da somministrare nell’acqua da bere per suini e polli doxycycline hyclate Powder for use in drinking water 500 mg/g Pigs and chickens Oral: In drinking water Latvia Eurovet Animal Health BV Handelsweg 25 5531 AE Bladel The Netherlands Soludox 500 mg/g pulveris lietošanai ar dzeramo ūdeni cūkām un vistām doxycycline hyclate Powder for use in drinking water 500 mg/g Pigs and chickens Oral: In drinking water The Netherlands Eurovet Animal Health BV Handelsweg 25 5531 AE Bladel The Netherlands Soludox 500 mg/g poeder voor toediening via het drinkwater voor varkens en kippen doxycycline hyclate Powder for use in drinking water 500 mg/g Pigs and chickens Oral: In drinking water Slovakia Eurovet Animal Health BV Handelsweg 25 5531 AE Bladel The Netherlands Soludox 500 mg/g prášok na použitie v pitnej vode pre ošípané doxycycline hyclate Powder for use in drinking water 500 mg/g Pigs and chickens Oral: In drinking water Spain Eurovet Animal Health BV Handelsweg 25 5531 AE Bladel The Netherlands Soludox 500 mg/g polvo para administración en agua de bebida para porcino y pollos doxycycline hyclate Powder for use in drinking water 500 mg/g Pigs and chickens Oral: In drinking water United Kingdom Eurovet Animal Health BV Handelsweg 25 5531 AE Bladel The Netherlands Soludox 500 mg/g powder for use in drinking water for pigs and chickens doxycycline hyclate Powder for use in drinking water 500 mg/g Pigs and chickens Oral: In drinking water