Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
YERSINIA RUCKERI CELLS INACTIVATED (HAGERMAN STRAIN) YERSINIA RUCKERI STRAIN SP/07/04 INACTIVATED
Intervet International BV
QI10BB03
Concentrate for dip suspension
Immunological - Inactivated vaccine
Fish - (Rainbow) Trout
2009-10-09
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA:10847/003/001 Case No: 7004259 The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby grants to: INTERVET INTERNATIONAL WIM DE KORVERSTRAAT 35, NL - 5831 AN BOXMEER, NETHERLANDS an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the Veterinary Medicinal Product: AQUAVAC RELERA CONCENTRATE FOR DIP SUSPENSION OR SUSPENSION FOR INJECTION FOR RAINBOW TROUT The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may be specified in Part 2 of the said Schedule. This authorisation,unless previously revoked, shall continue in force from 09/10/2009 to 08/10/2014. Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/10/2009_ _CRN 7004259_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT AQUAVAC RELERA Concentrate for dip suspension or suspension for injection for Rainbow Trout 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Concentrate for dip suspension or suspension for injection Suspension in brown aqueous liquid 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Rainbow trout (_Oncorhynchus mykiss_) ACTIVE INGREDIENT(S) Inactivated cells of _Yersinia ruckeri_ ≥ 75% RPS* (Hagerman type 1 strain) Inactivated cells of _Yersinia ruckeri_ ≥ 75% RPS* (EX5 biotyp Прочитать полный документ