Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ETHAMBUTOL DIHYDROCHLORIDE
Cyanamid of Great Britain
400 Milligram
Film Coated Tablet
1977-04-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0037/008/002 Case No: 2039676 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CYANAMID OF GREAT BRITAIN FAREHAM ROAD, GOSPORT, HANTS, PO13 0AS, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product ETHAMBUTOL 400 MG 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 21/02/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/03/2008_ _CRN 2039676_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ethambutol 400mg Film Coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg Ethambutol Hydrochloride. Excipients: Each tablet contains 130mg sucrose and 23mg sorbitol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Smooth, grey, biconvex, bevel-edged film coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The primary treatment and re-treatment of tuberculosis and for prophylaxis in cases of inactive tuberculosis or large-tuberculin- positive reaction. Ethambutol should only be used in conjunction with other anti-tuberculous Read the complete document