BOVILIS RINGVAC
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-05-2024
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Active ingredient:
TRICHOPHYTON VERRUCOSUM STRAIN LTF-130
Available from:
Intervet Ireland Limited
ATC code:
QI02AP01
Pharmaceutical form:
Lyophilisate and solvent for suspension for injection
Therapeutic group:
Immunological - Live Vaccine
Therapeutic area:
Bovine
Authorization date:
2005-05-04
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
ANIMAL REMEDIES REGULATIONS, 2005
(S.I. NO. 734 OF 2005)
VPA: 10996/184/001
Case No: 7000605
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 734 of 2005) hereby grants to:
INTERVET IRELAND LIMITED
MAGNA DRIVE, MAGNA BUSINESS PARK, DUBLIN 24, 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:
BOVILIS RINGVAC
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 17/07/2006.
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 10/11/2006_
_CRN 7000605_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis Ringvac, lyophilisate for suspension for injection, for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per 1 ml of vaccine:
ACTIVE SUBSTANCE:
Attenuated _Trichophyton verrucosum, _strain LTF-130
9 x 10
6
and
21 x 10
6
viable microconidia.
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPE
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