Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
BENZALKONIUM CHLORIDE
Reckitt Benckiser Ireland Ltd
4 %w/v
Cutaneous Solution
1997-11-25
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0979/005/001 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 DETTOL FRESH 4% W/V CONCENTRATE FOR CUTANEOUS 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 24/11/2007. 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 Dettol Fresh 4 %w/v Concentrate for Cutaneous Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benzalkonium chloride 4.0 %w/v. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Concentrate for Cutaneous solution A clear, colourless concentrate for cutaneous solution with a characteristic lemon/pine odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an antiseptic for prophylaxis of topical infection in intact and abraded skin and for skin preparation prior to surgical or diagnostic procedure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration – topical to relevant areas. D Belgenin tamamını okuyun