Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TRIMEPRAZINE TARTARE
Sanofi-Aventis Ireland Limited
30 MG/5ml
Syrup
2004-12-03
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0540/131/001 Case No: 2067670 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SANOFI-AVENTIS IRELAND LIMITED CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product VALLERGAN FORTE 30 MG / 5 ML 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 22/02/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 04/03/2010_ _CRN 2067670_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vallergan Forte 30 mg / 5 ml Oral Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of oral solution contains 30 mg of Alimemazine (Trimeprazine) Tartrate. Excipients: Sucrose 3.40 g / 5ml Sodium sulphite anhydrous (E221) 5.0 mg / 5ml Sodium metabisulphite (E223) 5.0 mg / 5ml Ethanol (96% v/v) 201.5 mg / 5ml For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral solution. A clear, colourless to very pale yellow solution with an odour of apricots. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. In the management of urticaria, pruritus (including that associated with obst Read the complete document