Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
THIAMINE HYDROCHLORIDE, RIBOFLAVIN SODIUM PHOSPHATE, PYRIDOXINE HYDROCHLORIDE, NICOTINAMIDE, ASCORBIC ACID
Norbrook Laboratories Limited
QA11EB
THIAMINE HYDROCHLORIDE, RIBOFLAVIN SODIUM PHOSPHATE, PYRIDOXINE HYDROCHLORIDE, NICOTINAMIDE, ASCORBIC ACID
%v/v
Solution for Injection
LM-Licensed Merchant
Bovine, Ovine, Porcine
Vitamin B-complex, with vitamin C
Vitamins & Minerals
Authorised
1991-10-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10999/050/001 Case No: 7001096 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: NORBROOK LABORATORIES LIMITED STATION WORKS, CAMLOUGH ROAD, CO. DOWN BT35 6JP 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: COMBIVIT SOLUTION 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 the said Schedule. The authorisation, unless previously revoked, shall continue in force from 30/09/2006. 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 17/07/2008_ _CRN 7001096_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Combivit Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Solution for injection A clear, pale yellow sterile aqueous solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, Sheep, Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of cerebrocortical necrosis in cattle and sheep and for the treatment of Vita Read the complete document