Source: HPRA (Health Products Regulatory Authority)
Teva Pharma B.V.
License IRISH MEDICINES BOARD ACT 1995, as amended Medicinal Products (Control of Placing on the Market) Regulations, 2007, as amended PA0749/022/001 Case No: 2082897 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Netherlands an authorisation, subject to the provisions of the said Regulations, in respect of the product Galantamine Teva 4mg Film-coated Tablets the particulars of which are set out in 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 01/09/2010 until 18/12/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. Irish Medicines Board ______________________________________________________________________________________________________________________ Date Printed 01/09/2010 CRN 2082897 page number: 1 Part II Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Galantamine Teva 4mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 4 Read the complete document