EN Official Journal of the European Union C 76/10

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2016 to 31 January 2016

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

(2016/C 076/02)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the decision Name(s) of the medicinal product INN (International Non-Proprietary Name) Holder(s) of the marketing authorisation Member State concerned Date of notification 7.1.2016 Solamocta See Annex I See Annex I See Annex I 8.1.2016 14.1.2016 Ambroxol or Bromhexine See Annex II See Annex II See Annex II 15.1.2016 18.1.2016 Bimatoprost Bimatoprost Not applicable Not applicable 19.1.2016

See Annex.

These Decisions are addressed to the Member States.

(1) OJ L 311, 28.11.01, p. 67.

(2) OJ L 311, 28.11.01, p. 1.

ANNEX I List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States Member State EU/EEA Applicant Name INN Strength Pharmaceutical form Animal species Route of administration Austria Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral Belgium Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral Czech Republic Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral Denmark Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral France Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral Germany Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral Greece Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral Hungary Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral Ireland Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral Italy Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral Luxembourg Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral Poland Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral Portugal Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral Slovakia Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral Spain Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral The Netherlands Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral United Kingdom Eurovet Animal Health BV Handelsweg 25 NL-5531 AE Bladel The Netherlands Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys Amoxicillin trihydrate 800 mg/g Powder for use in drinking water Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys Oral