Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE SALT
Imbat Limited
4 Milligram
Tablets
2007-01-05
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1151/014/001 Case No: 2069197 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to IMBAT LIMITED UNIT L2, NORTH RING BUSINESS PARK, SANTRY, DUBLIN 9 an authorisation, subject to the provisions of the said Regulations, in respect of the product COVERSYL, 4 MILLIGRAM 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 26/08/2009 until 04/01/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 04/09/2009_ _CRN 2069197_ _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 UK:_ Light green, oblong shaped, engraved with the company 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 once daily in the m Baca dokumen lengkap