Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
VALSARTAN HYDROCHLOROTHIAZIDE, MICRONIZED
Novartis Pharmaceuticals UK Ltd
320/25 Milligram
Film Coated Tablet
2008-02-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0013/118/005 Case No: 2057548 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NOVARTIS PHARMACEUTICALS UK LTD FRIMLEY BUSINESS PARK, FRIMLEY, CAMBERLEY, SURREY, GU16 7SR, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CO-TAREG 320MG/25 MG 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 26/02/2009 until 31/01/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/02/2009_ _CRN 2057548_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Co-Tareg 320 mg/25 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 320 mg valsartan and 25 mg hydrochlorothiazide. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow, ovaloid shaped, beveled edge, film coated tablet, imprinted (debossed) with “NVR” on one side and “CTI” on the reverse side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Co-Tareg320 mg/25 mg fixed dose-combination (valsartan 320 mg/hydrochlorothiazide 25 mg) is Read the complete document