Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
MEFENAMIC ACID
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK
MEFENAMIC ACID
500 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2014-06-03
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0282/048/002 Case No: 2065827 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NORTON HEALTHCARE LIMITED T/A IVAX PHARMACEUTICALS UK REGENT HOUSE, 5-7 BROADHURST GARDENS, SWISS COTTAGE, LONDON NW6 3RZ, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product MEFENAMIC ACID, 500 MILLIGRAM The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 19/05/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/05/2009_ _CRN 2065827_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mefenamic Acid 500 mg Film-Coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mefenamic Acid 500 mg. Sunset yellow (E110) content of approximately 0.0625mg per tablet. For excipients, see 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow, film-coated, ovoid tablets, about 18mm by 10mm, embossed ‘MEF 500’ on one face with a twin triangle logo on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of mild to moderate pain associated with rheumatic muscular or arthritic disorders (including rheumatoid arthritis, and osteo-art Lire le document complet