País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
NICOTINE
Pierre Fabre Medicament
NICOTINE
2.5 Milligram
Lozenges
Product not subject to medical prescription
Withdrawn
2012-12-31
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0329/010/003 Case No: 2067398 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PIERRE FABRE MEDICAMENT 45 PLACE ABEL GANCE, 92100 BOULOGNE, CEDEX, FRANCE an authorisation, subject to the provisions of the said Regulations, in respect of the product NICOPASS LIQUORICE MINT 2.5MG LOZENGE 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 23/04/2010 until 22/04/2015. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/04/2010_ _CRN 2067398_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicopass Liquorice Mint 2.5mg Lozenge 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains 2.50 mg nicotine corresponding to 13.88 mg nicotine resinate. Excipient : aspartame (1.00 mg), isomalt (2.30 g). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lozenge. Brown, opaque, square lozenge. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of nicotine withdrawal symptoms, in nicotine dependency as an aid to smoking cessation in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and elderly_ Lozenges containing 2.5 mg of nicotine are suitable for smoker Llegiu el document complet