País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
FAMCICLOVIR
Novartis Pharmaceuticals UK Ltd
750 Milligram
Coated Tablets
1996-10-21
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 COMPOSITION The active ingredient is famciclovir. Each tablet contains famciclovir 750 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, oval film-coated tablet, biconvex, bevelled edges, debossed with “FAMVIR 750” on one side and plain on the reverse side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ‘Famvir’ is indicated for the treatment of herpes zoster (shingles) infection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE: _ADULTS:_ Oral administration, one 750 Llegiu el document complet