Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
ATENOLOL CHLORTALIDONE
Profind Wholesale Ltd.
50/12.5 Milligram
Film Coated Tablet
2009-05-28
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PPA1500/016/001 Case No: 2083742 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PROFIND WHOLESALE LTD. UNIT 625, KILSHANE AVENUE, NORTHWEST BUSINESS PARK, DUBLIN 15, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product TENORET 50 MG/12.5 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 28/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/07/2010_ _CRN 2083742_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tenoret 50 mg/12.5 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains atenolol 50 mg and chlortalidone 12.5 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. _Product imported from the UK:_ Brown, biconvex, film-coated tablet imprinted with the name Tenoret 50 on one face and an ‘S’ logo on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The management of hypertension after initial stabilisation has been achieved with the active ingredients used separately. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults On Lestu allt skjalið