Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FAMCICLOVIR
Novartis Pharmaceuticals UK Ltd
750 Milligram
Coated Tablets
1996-10-21
License IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. No.540 of 2007) PA0013/106/004 Case No: 2042380 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Novartis Pharmaceuticals UK Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom an authorisation, subject to the provisions of the said Regulations, in respect of the product Famvir 750 mg 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 30/06/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. Irish Medicines Board ______________________________________________________________________________________________________________________ Date Printed 09/07/2009 CRN 2042380 page number: 1 Part II Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Famvir 750 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE Read the complete document