Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
TRIMEPRAZINE TARTARE
Sanofi-Aventis Ireland Limited T/A SANOFI
TRIMEPRAZINE TARTARE
7.5 MG/5ml
Syrup
Product subject to prescription which may be renewed (B)
Withdrawn
2012-05-28
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0540/132/001 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 7.5 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 7.5 mg / 5 ml Oral Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of oral solution contains 7.5 mg of Alimemazine (Trimeprazine) Tartrate. EXCIPIENTS For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. A clear, bright, straw-coloured solution with an odour of apricots. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. In the management of urticaria, pruritus (including that associated with obstructive jaundice) and senile pruritus. 2. In short term sedation and pre-anaesthetic medication in children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The route of Lesen Sie das vollständige Dokument