Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
FAMOTIDINE
B & S Healthcare
20 Milligram
Film Coated Tablet
2009-06-12
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1328/117/001 Case No: 2064922 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 PEPCID 20MG 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 12/06/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/06/2009_ _CRN 2064922_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pepcid 20 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of famotidine. For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Film-coated (Tablets). Beige, film-coated, round-cornered square tablets, engraved 'MSD 963' on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Duodenal ulcer. Prevention of relapses of duodenal ulceration. Benign gastric ulcer. Hypersecretory conditions such as Zollinger Ellison syndrome. Healing of oesophageal erosion or ulceration associated with gastro oesophageal reflux disease. Symptomatic relief o Przeczytaj cały dokument