Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BENAZEPRIL HYDROCHLORIDE
Novartis Animal Health UK Ltd
QC09AA07
5 mg/tablet
Coated Tablets
Cardiovascular
Canine
2010-05-07
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) 10825/009/001 Case No: 7006382 Transferred from 10835/025/001. The Irish Medicines Board in exercise of the powers conferred on it by the Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby grants to: NOVARTIS ANIMAL HEALTH UK LTD FRIMLEY BUSINESS PARK, FRIMLEY, SURREY GU16 7SR, ENGLAND 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: FORTEKOR 5 MG FILM-COATED TABLETS FOR DOGS AND CATS 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 revoked, shall continue in force from 07/05/2010 until 06/12/2010. 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 11/05/2010_ _CRN 7006382_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT FORTEKOR 5 mg film-coated tablets for dogs and cats. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: One tablet contains 5 mg benazepril hydrochloride Excipient(s): For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Light yellow, ovaloid, slightly biconvex tablets with score on both sides, marked “CG” on one side and “LV” on Read the complete document