SUVAXYN PARVO
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-05-2024
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Active ingredient:
PORCINE PARVOVIRUS STRAIN NADL-2, PPV-PK-7
Available from:
Fort Dodge Animal Health Limited
ATC code:
QI09AA02
Pharmaceutical form:
Suspension for Injection
Therapeutic group:
Immunological - Inactivated vaccine
Therapeutic area:
Porcine
Authorization date:
2002-10-23
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) REGULATIONS 2007
(S.I. NO. 144 OF 2007)
VPA: 10861/050/001
Case No: 7003442
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 144 of 2007) hereby grants to:
FORT DODGE ANIMAL HEALTH LIMITED
FLANDERS ROAD, HEDGE END, SOUTHAMPTON SO30 4QH, 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:
SUVAXYN PARVO
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 23/10/2007.
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 18/09/2007_
_CRN 7003442_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn Parvo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
* 50% Tissue Culture Infective Dose, prior to inactivation
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Gilts and sows aged six months or greater.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of gilts and sows to reduce parvovirus related still birth, foeta
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