País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
SERTRALINE HYDROCHLORIDE
Ranbaxy Ireland Limited
SERTRALINE HYDROCHLORIDE
100 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-09-10
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0408/059/002 Case No: 2088079 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to RANBAXY IRELAND LIMITED SPAFIELD, CORK ROAD, CASHEL, CO. TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product SERTRALINE RANBAXY 100 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 23/08/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/08/2010_ _CRN 2088079_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sertraline 100 mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 100 mg of sertraline as sertraline hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White film-coated caplet shaped tablet embossed with “100” on one side and break-line on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sertraline is indicated for the treatment of: Major depressive episodes 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sertraline should be taken once daily, either in the morning or evening Sertraline tablet can be administered with Leia o documento completo