Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
FAMOTIDINE
Merck Sharp and Dohme Limited
20 Milligram
Film Coated Tablet
1987-10-06
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0035/069/001 Case No: 2079101 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MERCK SHARP AND DOHME LIMITED HERTFORD ROAD, HODDESDON, HERTFORDSHIRE EN11 9BU, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product PEPCID 20 MG FILM-COATED TABLETS the particulars of which are set out in 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 27/08/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/08/2010_ _CRN 2079101_ _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 section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Beige, 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 of gastro-oesophageal re Perskaitykite visą dokumentą