AQUAVAC RELERA CONCENTRATE FOR DIP SUSPENSION OR S
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
14-05-2024
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Active ingredient:
YERSINIA RUCKERI CELLS INACTIVATED (HAGERMAN STRAIN) YERSINIA RUCKERI STRAIN SP/07/04 INACTIVATED
Available from:
Intervet International BV
ATC code:
QI10BB03
Pharmaceutical form:
Concentrate for dip suspension
Therapeutic group:
Immunological - Inactivated vaccine
Therapeutic area:
Fish - (Rainbow) Trout
Authorization date:
2009-10-09
Summary of Product characteristics
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
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