Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Bisoprolol hemifumarate
Imbat Limited
C07AB; C07AB07
Bisoprolol hemifumarate
7.5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Beta blocking agents, selective; bisoprolol
Authorised
2008-05-02
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1151/048/005 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 CARDICOR, 7.5 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 . Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _4_ _/_ _0_ _9_ _/_ _2_ _0_ _0_ _9_ _C_ _R_ _N_ _ _ _2_ _0_ _6_ _9_ _1_ _9_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardicor 7.5mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Film-Coated Tablet contains 7.5mg bisoprolol hemifumarate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-Coated Tablet. _Product imported from Italy and the UK._ Each tablet is yellow, heart-shaped, scored and Film-Coated 4 CLINICAL PARTICULAR Przeczytaj cały dokument