PREGSURE BVD EMULSION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
29-04-2024
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Active ingredient:
BOVINE VIRAL DIARRHOEA VIRUS (BVD), STRAIN 5960, KILLED
Available from:
Pfizer Healthcare Ireland
ATC code:
QI02AA01
Pharmaceutical form:
Emulsion for Injection
Therapeutic group:
Immunological - Inactivated vaccine
Therapeutic area:
Bovine
Authorization date:
2005-04-13
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10019/104/001
Case No: 7005418
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:
PFIZER HEALTHCARE IRELAND
TRADING AS PFIZER ANIMAL HEALTH, RINGASKIDDY, CO. CORK, 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:
PREGSURE BVD EMULSION FOR INJECTION
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 13/11/2009.
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 14/11/2009_
_CRN 7005418_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
PregSure BVD Emulsion for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (2 ml) contains:
ACTIVE SUBSTANCE:
inactivated Bovine Viral Diarrhoea (BVD) type 1 virus, cytopathogenic strain 5960; to induce a geometric mean seroneutralizing
titre in guinea pigs of at least 5.6 log
2
ADJUVANT:
Procision-A™ :
0.164 ml/dose of vaccine
Composition of Procision-A™ (per ml)
Quil A
3.05 mg
Cholesterol
3.0
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