Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CARPROFEN
Intervet Ireland Limited
QM01AE91
50 mg/tablet
Tablets
N.S.A.I.D
Canine
2007-12-07
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10996/206/002 Case No: 7004927 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: 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: CARPROFEN INTERVET 50 MG TABLETS FOR DOGS 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 10/06/2009 until 06/12/2012. 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 12/06/2009_ _CRN 7004927_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Carprofen Intervet 50 mg tablets for dogs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE(S): Carprofen Intervet 50 mg tablets for dogs: 1 tablet contains: Active substance: 50 mg Carprofen EXCIPIENTS: For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to slightly brown bone shape, one side scored tablet with little brown spots 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FO Read the complete document