Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
PARACETAMOL ASCORBIC ACID
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
600/40 Milligram
Powder for Oral Solution
2006-10-20
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0678/106/002 Case No: 2056332 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to GLAXOSMITHKLINE CONSUMER HEALTHCARE (IRELAND) LIMITED STONEMASONS WAY, RATHFARNHAM, DUBLIN 16, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product BEECHAMS COLD & FLU HOT BLACKCURRANT 600MG/40MG POWDER FOR ORAL SOLUTION 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 07/10/2008 until 19/10/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 07/10/2008_ _CRN 2056332_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Beechams Cold & Flu Hot Blackcurrant 600mg/40mg Powder for oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE CONSTITUENTS MG / 6 G POWDER SACHET Paracetamol 600.00 Ascorbic Acid 40.00 For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. A pink / mauve coloured free flowing powder with an odour of blackcurrant. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The relief of symptoms of influenza and feverish colds including headache, and aches and pains. Also effective in the relief of menstrual Läs hela dokumentet