Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ZAFIRLUKAST
B & S Healthcare
20 Milligram
Film Coated Tablet
2006-10-06
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PPA1328/044/001 Case No: 2034068 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to B & S HEALTHCARE UNIT 4, BRADFIELD ROAD, RUISLIP, MIDDLESEX, HA4 0NU, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product ACCOLATE 20 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 26/03/2007 until 05/10/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/04/2007_ _CRN 2034068_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Accolate 20 mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20mg of zafirlukast. Excipients include lactose. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablets (Tablets) _Product imported from Portugal:_ White, round, biconvex film-coated tablets intagliated with ‘Accolate 20’ on one side and plain on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Accolate is indicated for the prophylaxis and chronic treatment of asthma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Accolate is taken to prevent asthma attacks and should the Read the complete document