VANGUARD CPV-L
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-05-2024
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Active ingredient:
CANINE PARVOVIRUS, STRAIN NL-35-D, LIVE ATTENUATED LEPTOSPIRA CANICOLA INACTIVATED LEPTOSPIRA ICTEROHAEMORRHAGIAE INACTIVATED
Available from:
Pfizer Healthcare Ireland
ATC code:
QI07AI05
Pharmaceutical form:
Solution for Injection
Therapeutic group:
Immunological - Mixed vaccine (live and inactivated)
Therapeutic area:
Canine
Authorization date:
2004-11-05
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
VPA: 10019/073/001
Case No: 7007027
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:
VANGUARD CPV-L
The particulars of which are set out in the attached Schedule. The authorisation is also subject to any special conditions as may be specified in
the Schedule.
The authorisation,unless revoked, shall continue in force from 30/08/2010.
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 31/08/2010_
_CRN 7007027_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
VANGUARD CPV-L
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Quantity per 1 ml dose
ACTIVE SUBSTANCE(S):
Live attenuated canine Parvovirus, strain NL-35-D, low passage, minimum : 10
7.0
CCID
50
*
Inactivated _Leptospira canicola_, at least 40 hamster protective doses and inactivated _Leptospira icterohaemorrhagiae_,
at least 40 hamster protective doses.
*Cell culture infectious dose-50
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear to slightly turbid liq
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