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Document 52013XC0927(06)
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 )
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 )
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 )
OJ C 282, 27.9.2013, p. 6–10
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |