Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
VENLAFAXINE HYDROCHLORIDE
Ranbaxy (UK) Limited
VENLAFAXINE HYDROCHLORIDE
37.5 Milligram
Tablets
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-06-04
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0967/010/001 Case No: 2051240 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to RANBAXY (UK) LIMITED 20 BALDERTON STREET, LONDON W1K 6TL, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product VENLAFAXINE 37.5 MG 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 22/08/2008 until 29/11/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/09/2008_ _CRN 2051240_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Venlafaxine 37.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 37.5mg venlafaxine (equivalent to 42.413mg of venlafaxine hydrochloride). For a full list of excipients, see section 6.1. Each tablet also contains lactose anhydrous. 3 PHARMACEUTICAL FORM Tablet Venlafaxine 37.5mg Tablets are peach coloured, mottled, uncoated, shield shaped tablets debossed with ‘V’ and ‘2’ on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MAJOR DEPRESSIVE DISORDER Venlafaxine 37.5mg Tablets are indicated for the treatment of major depressive disorder including Olvassa el a teljes dokumentumot