Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
NICOTINE RESIN
McNeil Healthcare (Ireland) Ltd
4 Milligram
Medicated Chewing Gum
2006-07-28
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0823/049/018 Case No: 2062316 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MCNEIL HEALTHCARE (IRELAND) LTD AIRTON ROAD, TALLAGHT, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product NICORETTE SPICEMINT 4MG MEDICATED CHEWING GUM 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 24/06/2009 until 27/07/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/06/2009_ _CRN 2062316_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicorette Spicemint 4mg Medicated Chewing Gum 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each medicated chewing gum contains 4 mg nicotine as a resin complex. For full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Medicated Chewing Gum. A square, coated, cream coloured chewing gum. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of tobacco dependence by relieving nicotine craving and withdrawl symptoms therby facilitating smoking cessation in smokers motivated to quit. Helping smokers temporarily abstain from smoking. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nic Read the complete document