COVEXIN 8 SUSPENSION FOR INJECTION FOR SHEEP AND CATTLE
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
11-06-2024
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Viambatanisho vya kazi:
CLOSTRIDIUM PERFRINGENS TYP B CLOSTRIDIUM PERFRINGENS TYPE C TOXOID CLOSTRIDIUM PERFRINGENS TYPE D TOXOID CLOSTRIDIUM HAEMOLYTICUM ANACULTURE CLOSTRIDIUM CHAUVOEI WHOLE CULTURE CLOSTRIDIUM NOVYI ANACULTURE CLOSTRIDIUM SEPTICUM TOXOID CLOSTRIDIUM TETANI TOXOID
Inapatikana kutoka:
Pfizer Healthcare Ireland
ATC kanuni:
QI02AB01
Dawa fomu:
Suspension for Injection
Kundi la matibabu:
Immunological - Inactivated vaccine
Eneo la matibabu:
Bovine
Idhini ya tarehe:
2009-05-29
Tabia za bidhaa
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
VPA: 10019/115/001
Case No: 7008322
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:
COVEXIN 8 SUSPENSION FOR INJECTION FOR SHEEP AND CATTLE
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 13/01/2010.
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 21/08/2010_
_CRN 7008322_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Covexin 8 Suspension for injection for sheep and cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
* ELISA According to Ph.Eur.
** Challenge test according to Ph.Eur.
#
In vitro toxin neutralisation test based on haemolysis of sheep erythrocytes.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
Light brown aqueous suspension that settles on storage.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep from 2 weeks of
Soma hati kamili
