ISSN 1977-091X
doi:10.3000/1977091X.C_2013.282.eng
Official Journal
of the European Union
C 282
English edition
Information and Notices
Volume 56
27 September 2013
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ISSN 1977-091X doi:10.3000/1977091X.C_2013.282.eng |
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Official Journal of the European Union |
C 282 |
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English edition |
Information and Notices |
Volume 56 |
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Notice No |
Contents |
page |
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IV Notices |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
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European Commission |
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2013/C 282/01 |
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2013/C 282/02 |
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EN |
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IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
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27.9.2013 |
EN |
Official Journal of the European Union |
C 282/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2013 to 31 August 2013
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )
2013/C 282/01
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
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5.8.2013 |
Pomalidomide Celgene |
Pomalidomide |
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EU/1/13/850 |
Capsule, hard |
L04AX06 |
8.8.2013 |
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5.8.2013 |
Somatropin Biopartners |
somatropin |
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EU/1/13/849 |
Powder and solvent for prolonged-release suspension for injection |
H01AC01 |
8.8.2013 |
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12.8.2013 |
Voncento |
human coagulation factor VIII/human von Willebrand factor |
CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland |
EU/1/13/857 |
Powder and solvent for solution for injection/infusion |
B02BD06 |
14.8.2013 |
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26.8.2013 |
AUBAGIO |
Teriflunomide |
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EU/1/13/838 |
Film-coated tablet |
L04AA31 |
29.8.2013 |
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26.8.2013 |
Cholib |
fenofibrate/simvastatin |
Abbott Healthcare Products Ltd Mansbridge Road, West End Southampton, SO18 3JD, United Kingdom |
EU/1/13/866 |
Film-coated tablet |
C10BA04 |
28.8.2013 |
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26.8.2013 |
Nexium Control |
esomeprazole |
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EU/1/13/860 |
Gastro-resistant tablet |
A02BC05 |
29.8.2013 |
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26.8.2013 |
Stivarga |
regorafenib |
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EU/1/13/858 |
Film-coated tablet |
L01XE21 |
29.8.2013 |
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26.8.2013 |
Tafinlar |
DABRAFENIB |
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EU/1/13/865 |
Capsule, hard |
L01XE23 |
29.8.2013 |
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
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5.8.2013 |
Icandra |
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EU/1/08/484 |
8.8.2013 |
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5.8.2013 |
Marixino |
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EU/1/13/820 |
8.8.2013 |
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5.8.2013 |
Rasilamlo |
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EU/1/11/686 |
8.8.2013 |
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5.8.2013 |
Xarelto |
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EU/1/08/472 |
8.8.2013 |
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5.8.2013 |
Zomarist |
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EU/1/08/483 |
8.8.2013 |
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12.8.2013 |
Circadin |
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EU/1/07/392 |
14.8.2013 |
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12.8.2013 |
Pixuvri |
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EU/1/12/764 |
14.8.2013 |
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12.8.2013 |
Signifor |
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EU/1/12/753 |
14.8.2013 |
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12.8.2013 |
Twynsta |
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EU/1/10/648 |
14.8.2013 |
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12.8.2013 |
Zavesca |
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EU/1/02/238 |
14.8.2013 |
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14.8.2013 |
Conbriza |
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EU/1/09/511 |
19.8.2013 |
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14.8.2013 |
FLUENZ |
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EU/1/10/661 |
19.8.2013 |
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14.8.2013 |
IOA |
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EU/1/11/689 |
19.8.2013 |
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26.8.2013 |
ADCETRIS |
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EU/1/12/794 |
28.8.2013 |
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26.8.2013 |
Azarga |
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EU/1/08/482 |
29.8.2013 |
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26.8.2013 |
Ceplene |
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EU/1/08/477 |
28.8.2013 |
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26.8.2013 |
Eliquis |
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EU/1/11/691 |
29.8.2013 |
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26.8.2013 |
Eylea |
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EU/1/12/797 |
28.8.2013 |
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26.8.2013 |
Herceptin |
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EU/1/00/145 |
28.8.2013 |
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26.8.2013 |
Hirobriz Breezhaler |
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EU/1/09/594 |
29.8.2013 |
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26.8.2013 |
Ifirmasta |
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EU/1/08/480 |
29.8.2013 |
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26.8.2013 |
Ilaris |
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EU/1/09/564 |
28.8.2013 |
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26.8.2013 |
Inlyta |
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EU/1/12/777 |
29.8.2013 |
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26.8.2013 |
Invega |
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EU/1/07/395 |
28.8.2013 |
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26.8.2013 |
Keppra |
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EU/1/00/146 |
29.8.2013 |
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26.8.2013 |
Onbrez Breezhaler |
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EU/1/09/593 |
29.8.2013 |
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26.8.2013 |
Oslif Breezhaler |
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EU/1/09/586 |
28.8.2013 |
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26.8.2013 |
Pramipexole Teva |
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EU/1/08/490 |
29.8.2013 |
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26.8.2013 |
Tarceva |
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EU/1/05/311 |
29.8.2013 |
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26.8.2013 |
Tysabri |
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EU/1/06/346 |
29.8.2013 |
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26.8.2013 |
Ventavis |
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EU/1/03/255 |
29.8.2013 |
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26.8.2013 |
XALKORI |
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EU/1/12/793 |
29.8.2013 |
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26.8.2013 |
Zypadhera |
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EU/1/08/479 |
29.8.2013 |
— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
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5.8.2013 |
Econor |
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EU/2/98/010 |
9.8.2013 |
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12.8.2013 |
Trocoxil |
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EU/2/08/084 |
14.8.2013 |
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14.8.2013 |
Cerenia |
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EU/2/06/062 |
19.8.2013 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
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The European Medicines Agency |
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7, Westferry Circus, |
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Canary Wharf |
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UK-LONDON E14 4H |
(1) OJ L 136, 30.4.2004, p. 1.
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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
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Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
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12.8.2013 |
Soludox |
See Annex I |
See Annex I |
13.8.2013 |
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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
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Member State EU/EEA |
Marketing authorisation holder |
Name |
INN |
Pharmaceutical form |
Strength |
Animal species |
Route of administration |
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Austria |
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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 |
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Czech Republic |
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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 |
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Estonia |
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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 |
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Finland |
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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 |
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France |
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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 |
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Germany |
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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 |
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Greece |
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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 |
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Italy |
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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 |
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Italy |
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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 |
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Latvia |
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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 |
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The Netherlands |
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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 |
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Slovakia |
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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 |
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Spain |
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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 |
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United Kingdom |
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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
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Member State EU/EEA |
Applicant |
Name |
INN |
Pharmaceutical form |
Strength |
Animal species |
Route of administration |
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Austria |
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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 |
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Czech Republic |
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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 |
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Denmark |
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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 |
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France |
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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 |
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Germany |
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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 |
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Ireland |
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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 |
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Italy |
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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 |
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The Netherlands |
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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 |
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Portugal |
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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 |
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Spain |
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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 |
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United Kingdom |
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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 |