EQUILIS RESEQUIN SUSPENSION FOR INJECTION, FOR HOR

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

EQUINE HERPES VIRUS TYPE 1, STRAIN RAC-H INACTIVATED EQUINE HERPES VIRUS TYPE 4, STRAIN 2252 INACTIVATED INFLUENZA VIRUS ANTIGEN STRAIN A/EQUI 1/PRAGUE 56 INACTIVATED INFLUENZA VIRUS ANTIGEN STRAIN A/EQUI 2/NEWMARKET 1/93 INACTIVATED INFLUENZA VIRUS ANTIGEN STRAIN A/EQUI 2/NEWMARKET 2/93 INACTIVATED

Available from:

Intervet Ireland Limited

ATC code:

QI05AA04

Pharmaceutical form:

Suspension for Injection

Therapeutic group:

Immunological - Inactivated vaccine

Therapeutic area:

Equine - Food

Authorization date:

2001-04-10

Summary of Product characteristics

IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10996/158/002
Case No: 7007677
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:
EQUILIS RESEQUIN SUSPENSION FOR INJECTION, FOR HORSES
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 previously revoked, shall continue in force from 25/01/2010.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: From this date of effect, this authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/04/2010_
_CRN 7007677_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Equilis Resequin Suspension for injection, for horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Per dose (2 ml)
Inactivated equine herpes virus type 1 (EHV1), strain RAC-H 
at least 10
7.8
TCID
50
*
Inactivated equine herpes virus type 4 (EHV4), strain 2252 at least 10
6.5
TCID
50
*
Inactivated equine influenza virus-antigens of the strains
A/equi 1/Prague/1/56
50 microgram HA**

A/eq