Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
CAPTOPRIL
B & S Healthcare
CAPTOPRIL
12.5 Milligram
Tablets
Withdrawn
2011-03-16
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1328/056/001 Case No: 2060928 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 CAPOTEN 12.5MG 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 14/12/2009 until 09/11/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/12/2009_ _CRN 2060928_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Capoten 12.5mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 12.5 mg captopril. Excipients: lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from Spain:_ White, flat-faced, bevel-edged, capsule-shaped tablet, engraved with ‘Squibb’ and ‘450’ on one side with a bisecting bar on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION: Capoten is indicated for the treatment of hypertension. HEART FAILURE: Capoten is indicated for the treatment of chronic heart failure with reduction of systolic ventricula Lire le document complet