Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE SALT
B & S Healthcare
4 Milligram
Tablets
2006-09-15
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PPA1328/022/001 Case No: 2034068 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 COVERSYL 4 MG 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 26/03/2007 until 14/09/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/04/2007_ _CRN 2034068_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Coversyl 4mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg perindopril tert-butylamine salt, equivalent to 3.338 mg perindopril Excipients: Lactose For a full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Tablet. _Product imported from the Netherlands and Spain:_ Light green, oblong shaped tablet, engraved with the Servier logo on one face and scored on both edges. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of hypertension Heart Failure Treatment of symptomatic heart failure 4.2 POSOLOGY AND METHOD OF ADMINISTRATION It is recommended that COVERSYL is taken o Read the complete document