Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SULFASALAZINE
Pharmacia Laboratories Limited
500 Milligram
Suppositories
1997-04-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0187/051/002 Case No: 2064836 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PHARMACIA LABORATORIES LIMITED RAMSGATE ROAD, SANDWICH, KENT, CT13 9NJ, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product SALAZOPYRIN 500 MG SUPPOSITORIES 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. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/09/2009_ _CRN 2064836_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Salazopyrin 500 mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains 500 mg of sulphasalazine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suppository The suppositories are odourless, orange/yellow in colour and torpedo-shaped. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Induction and maintenance of remission of such conditions as ulcerative colitis, proctocolitis, proctitis and Crohn’s disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND THE ELDERLY Two suppositories to be inserted after defaecation in the morning and in the evening. After Read the complete document