Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
GUAIFENESIN CETYLPYRIDINIUM CHLORIDE SODIUM CITRATE
Procter & Gamble (Health & Beauty Care) Limited
GUAIFENESIN CETYLPYRIDINIUM CHLORIDE SODIUM CITRATE
Per Cent
Syrup
Product not subject to medical prescription
Withdrawn
2013-03-21
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0441/007/002 Case No: 2069833 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PROCTER & GAMBLE (HEALTH & BEAUTY CARE) LTD THE HEIGHTS, BROOKLANDS, WEYBRIDGE, SURREY KT13 0XP, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product VICKS ORIGINAL COUGH SYRUP CHESTY GUAIFENESIN 50MG/5ML CETYLPYRIDINIUM CHLORIDE 1.25MG/5ML SODIUM CITRATE 200MG/5ML 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 13/05/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/05/2010_ _CRN 2069833_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vicks Original Cough Syrup Chesty Guaifenesin 50mg/5ml Cetylpyridinium Chloride 1.25mg/5ml Sodium Citrate 200mg/5ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of the syrup contains Gaifenesin 50 mg, Cetylpridinium Chloride 1.25 mg and Sodium Citrate 200 mg. Excipients: Each 5ml of syrup contains glucose 1.8g, sucrose 1.8g, ethanol 0.4g. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Syrup. A clear reddish-pink syrup having a characteristic cherry/aromatic aroma and taste. 4 CLI Perskaitykite visą dokumentą