Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DICLOFENAC POTASSIUM
Actavis Group PTC ehf
25mg Milligram
Film Coated Tablet
2009-08-28
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1380/078/001 Case No: 1999941 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ACTAVIS GROUP PTC EHF REYKJAVIKURVEGI 76-78, 220 HAFNARFJORDUR, ICELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product KYFLAM 25MG FILM-COATED TABLETS 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 28/08/2009 until 27/08/2014. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/09/2009_ _CRN 1999941_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kyflam 25 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg of diclofenac potassium. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Pink, circular, coated, biconvex. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term treatment of all grades of pain and inflammation in the following acute conditions: Post traumatic pain, inflammation and swelling, e.g. due to sprains. Acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendonitis, tenosynovitis, bursitis. Post-operative pain, inflammation and Read the complete document