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 or Article 38 of Directive 2001/82/EC )
Date: 2013-09-27
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013282EN.01000601.xml










27.9.2013   


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







ANNEX II

LIST OF THE NAME, 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


Pharmaceutical form


Strength


Animal species


Route of administration




Austria







Novartis Animal Health Inc.




Schwarzwaldallee 215




CH-4058 Basel




Switzerland






STRENZEN 500/125 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine


Amoxicillin, clavulanic acid


Powder for use in drinking water


500/125 mg/g


Pigs


Oral: In drinking water




Czech Republic







Novartis Animal Health Inc.




Schwarzwaldallee 215




CH-4058 Basel




Switzerland






STRENZEN 500/125 mg/g prášek pro podání v pitné vodě pro prasata


Amoxicillin, clavulanic acid


Powder for use in drinking water


500/125 mg/g


Pigs


Oral: In drinking water




Denmark







Novartis Animal Health Inc.




Schwarzwaldallee 215




CH-4058 Basel




Switzerland






STRENZEN 500/125 mg pulver til anvendelse i drikkevand til svin


Amoxicillin, clavulanic acid


Powder for use in drinking water


500/125 mg/g


Pigs


Oral: In drinking water




France







Novartis Animal Health Inc.




Schwarzwaldallee 215




CH-4058 Basel




Switzerland






STRENZEN 500/125 mg/g poudre pour eau de boisson porcs


Amoxicillin, clavulanic acid


Powder for use in drinking water


500/125 mg/g


Pigs


Oral: In drinking water




Germany







Novartis Animal Health Inc.




Schwarzwaldallee 215




CH-4058 Basel




Switzerland






STRENZEN 500/125 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine


Amoxicillin, clavulanic acid


Powder for use in drinking water


500/125 mg/g


Pigs


Oral: In drinking water




Ireland







Novartis Animal Health Inc.




Schwarzwaldallee 215




CH-4058 Basel




Switzerland






STRENZEN 500/125 mg/g powder for use in drinking water for pigs


Amoxicillin, clavulanic acid


Powder for use in drinking water


500/125 mg/g


Pigs


Oral: In drinking water




Italy







Novartis Animal Health Inc.




Schwarzwaldallee 215




CH-4058 Basel




Switzerland






STRENZEN 500/125 mg/g polvere per somministrazione in acqua da bere per suini


Amoxicillin, clavulanic acid


Powder for use in drinking water


500/125 mg/g


Pigs


Oral: In drinking water




The Netherlands







Novartis Animal Health Inc.




Schwarzwaldallee 215




CH-4058 Basel




Switzerland






STRENZEN 500/125 mg/g poeder voor gebruik in drinkwater voor varkens.


Amoxicillin, clavulanic acid


Powder for use in drinking water


500/125 mg/g


Pigs


Oral: In drinking water




Portugal







Novartis Animal Health Inc.




Schwarzwaldallee 215




CH-4058 Basel




Switzerland






STRENZEN 500/125 mg/g pó para utilização na água de bebida em suínos


Amoxicillin, clavulanic acid


Powder for use in drinking water


500/125 mg/g


Pigs


Oral: In drinking water




Spain







Novartis Animal Health Inc.




Schwarzwaldallee 215




CH-4058 Basel




Switzerland






STRENZEN 500/125 mg/g polvo para uso en agua de bebida para porcino


Amoxicillin, clavulanic acid


Powder for use in drinking water


500/125 mg/g


Pigs


Oral: In drinking water




United Kingdom







Novartis Animal Health Inc.




Schwarzwaldallee 215




CH-4058 Basel




Switzerland






STRENZEN 500/125 mg/g powder for use in drinking water for pigs


Amoxicillin, clavulanic acid


Powder for use in drinking water


500/125 mg/g


Pigs


Oral: In drinking water