HIPRABOVIS-4

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

INFECTIOUS BOVINE RHINOTRACHEITIS VIRUS STRAIN LA INACTIVATED, PARAINFLUENZA-3 VIRUS STRAIN SF4 INACTIVATED, BOVINE DIARRHOEA VIRUS STRAIN NADL INACTIVATED, LIVE BOVINE RESPIRATORY SYNCITIAL VIRUS STRAIN LYM-56

Available from:

Laboratorios Hipra S.A.

ATC code:

QI02AH

INN (International Name):

INFECTIOUS BOVINE RHINOTRACHEITIS VIRUS STRAIN LA INACTIVATED, PARAINFLUENZA-3 VIRUS STRAIN SF4 INACTIVATED, BOVINE DIARRHOEA VI

Dosage:

Per Cent

Pharmaceutical form:

Pdr+Solv for Susp for Inj

Prescription type:

POM

Therapeutic group:

Bovine

Therapeutic area:

Live and inactivated viral vaccines

Therapeutic indications:

Immunological - Mixed vaccine (live and inactivated)

Authorization status:

Authorised

Authorization date:

2003-06-06

Summary of Product characteristics

IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10846/003/001
Case No: 7004204
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:
LABORATORIOS HIPRA S.A.
AVDA. LA SELVA 135, 17170 - AMER (GIRONA), SPAIN
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:
HIPRABOVIS-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 previously revoked, shall continue in force from 05/06/2008.
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 18/02/2009_
_CRN 7004204_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
HIPRABOVIS-4 
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Powder for reconstitution for suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle from 2 months of age.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
To stimulate active immunity against IBR, PI3, BVD and BRS viruses in cattle.
For active immunisation of cattle to reduce clinical signs of Bovine Respiratory Syndrome associated with I