Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
NALTREXONE HYDROCHLORIDE
Bristol-Myers Squibb Pharmaceuticals Ltd
50 Milligram
Tablets
2001-12-03
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0002/074/001 Case No: 2029213 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BRISTOL-MYERS SQUIBB SWORDS, CO. DUBLIN, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product REVIA 50 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 03/12/2006. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/05/2007_ _CRN 2029213_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Revia 50 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg naltrexone hydrochloride. Excipients: Lactose monohydrate, 204 mg per tablet For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pale yellow, capsule-shaped tablets, debossed on one side with ‘R11’ and scored and debossed with ‘50’ on the other side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use within a comprehensive treatment programme for alcohol dependence to reduce the risk of relapse, support abstinence Read the complete document