Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
PARACETAMOL ASCORBIC ACID PHENYLEPHRINE HYDROCHLORIDE
Reckitt Benckiser Ireland Ltd
650/50/10m Milligram
Powder for Oral Solution
1999-09-24
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0979/013/002 Case No: 2032524 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to RECKITT BENCKISER IRELAND LTD 7 RIVERWALK, CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product LEMSIP PHARMACY BLACKCURRANT WITH PHENYLEPHRINE 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 06/02/2007 until 23/09/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/04/2007_ _CRN 2032524_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lemsip Pharmacy Blackcurrant with Phenylephrine Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For excipients, see 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution Pale lilac coloured powder with an odour and taste of blackcurrant. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of the symptoms associated with the common cold or influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ORAL. Adults and children over 12 years only: The usual dose is the contents of one sachet. The dose may be repeated in 4 hours with a maximum of four Lire le document complet