NORVAX COMPACT 4
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
AEROMONAS SALMONICIDA SUBSP. SALMONICIDA VIBRIO SALMONICIDA VIBRIO ANGUILLARUM SEROVAR O1 VIBRIO ANGUILLARUM SEROVAR 02
Available from:
Intervet Ireland Limited
ATC code:
QI10AB02
Pharmaceutical form:
Emulsion for Injection
Therapeutic group:
Immunological - Inactivated vaccine
Therapeutic area:
Fish - (Atlantic) Salmon
Authorization date:
2003-07-29
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10996/175/001
Case No: 7000438
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 IRELAND LIMITED
MAGNA DRIVE, MAGNA BUSINESS PARK, DUBLIN 24, IRELAND
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:
NORVAX COMPACT 4
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 the said Schedule.
The authorisation,unless revoked, shall continue in force from 03/11/2008.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 04/11/2008_
_CRN 7000438_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norvax Compact 4
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
[1] Measured in the batch release potency test. RPS
60
= Relative percent survival at 60% control mortality = (1 - {%
vaccinate mortality/ 60 % control mortality}) x 100
3 PHARMACEUTICAL FORM
Emulsion for injection. White to nearly white.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Fish (Atlantic salmon (_Salmo salar_)).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of Atlantic salmon
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