Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LEVOMENTHOL EUCALYPTUS GLOBULUS
Cadbury Trebor Bassett
Lozenges
2008-02-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1326/001/002 Case No: 2022247 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CADBURY TREBOR BASSETT BOURNVILLE LANE, BIRMINGHAM B30 2QZ, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product HALLS MENTHOLYPTUS EXTRA STRONG LOZENGE 0.52% W/W LEVO-MENTHOL 0.26% W/W EUCALYPTUS OIL 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 01/02/2008 until 31/01/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 02/02/2008_ _CRN 2022247_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Halls Mentholyptus Extra Strong Lozenge 0.52%w/w levo-menthol 0.26%w/w Eucalyptus oil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 3.78g lozenge contains: levo-menthol 0.52%w/w and Eucalyptus oil 0.26%w/w. Also contains sucrose. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Lozenge A hard translucent, uncoloured, square-shaped boiled sugar lozenge with the letter “H” embossed in the centre. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of discomforts caused by head colds, nasal congestion, so Read the complete document