Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
QUINAPRIL HYDROCHLORIDE
B & S Healthcare
5 Base Milligrams
Film Coated Tablet
2006-12-08
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1328/045/002 Case No: 2060052 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 ACCUPRO 5MG 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 31/03/2009 until 07/12/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 31/03/2009_ _CRN 2060052_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Accupro 5 mg Film - Coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5mg quinapril base (as 5.416mg quinapril hydrochloride). Excipients: Lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Italy:_ The tablets are brown film-coated elliptical tablets, imprinted with a scoreline on both sides and marking '5' on one side of the scoreline on both sides of the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (1) For the treatment of all grades of essential hypertension. Lestu allt skjalið