PROCYON DOG PARVO LYOPHILISATE AND SOLVENT FOR SUS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
13-05-2024
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Active ingredient:
CANINE PARVOVIRUS SAH2B
Available from:
Schering Plough Limited
ATC code:
QI07AD01
Pharmaceutical form:
Lyophilisate and solvent for suspension for injection
Therapeutic group:
Immunological - Live Vaccine
Therapeutic area:
Canine
Authorization date:
2009-02-06
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA:10277/105/001
Case No: 7004027
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:
SCHERING-PLOUGH LIMITED
SHIRE PARK, WELWYN GARDEN CITY, HERTFORDSHIRE AL7 1TW, UNITED KINGDOM
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:
PROCYON DOG PARVO LYOPHILISATE AND SOLVENT FOR SUSPENSION 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 Part 2 of the said Schedule.
This authorisation,unless previously revoked, shall continue in force from 06/02/2009 to 05/02/2014.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/02/2009_
_CRN 7004027_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Procyon Dog Parvo
Lyophilisate and solvent for suspension for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
i.
P - freeze dried fraction
ii.
Liquid diluent fraction
1
Tissue culture infective dose 50%
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection
The freeze dried fraction is a lightish brown pellet and the solvent (and the reconstituted product) is a pink/red slightly
opalescent suspension.
4 CLINICAL PART
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