Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
VENLAFAXINE HYDROCHLORIDE
Imbat Limited
75 Milligram
Tablets
2008-11-21
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1151/076/002 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 EFEXOR 75 MG TABLETS, 75 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. 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 Efexor 75mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75mg of venlafaxine (as venlafaxine hydrochloride). Also contains: Lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from the UK_ Peach coloured, shield-shaped tablets impressed with the tablet strenght "75" and embossed with a "W" on on side, and plain on the other 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes. For prevention of recurrence of major depressive episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Major depressive episodes The recommend Read the complete document