Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TRANDOLAPRIL
B & S Healthcare
2 Milligram
Capsules Hard
2009-05-08
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1328/094/001 Case No: 2061040 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 GOPTEN 2MG HARD CAPSULES 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 08/05/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/05/2009_ _CRN 2061040_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gopten 2 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Trandolapril 2 mg Excipients: also includes Lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard Capsules (capsules) _Product imported from the UK:_ Size 4, hard gelatin capsules, with an opaque red body and an opque red cap, containing a practically white granular mass. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION All grades of essential hypertension. Gopten may be used alone or in combination with other antihypertensive agents. LEFT VENTRICULAR DYSFUNCTION AFTER MY Read the complete document