Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
CARPROFEN
Pfizer Healthcare Ireland
QM01AE91
50 mg/tablet
Tablets
N.S.A.I.D
Canine
2004-03-19
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10019/079/002 Case No: 7006084 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: RIMADYL PALATABLE TABLETS 50 MG 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 09/09/2009. 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 11/09/2009_ _CRN 7006084_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Rimadyl Palatable Tablets 50 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg Carprofen. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Chewable tablets. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For analgesia and reduction of chronic inflammation, for example in degenerative joint disease, in the dog. Rimadyl Palatable Tablets can also be used Lire le document complet