Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
DICLOFENAC SODIUM
B & S Healthcare
DICLOFENAC SODIUM
3 %w/w
Gel
Withdrawn
2011-03-16
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1328/062/001 Case No: 2073679 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to B & S HEALTHCARE UNIT 4, BRADFIELD ROAD, RUISLIP, MIDDLESEX, HA4 0NU, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product SOLARAZE 3% GEL 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 15/12/2009 until 28/09/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/12/2009_ _CRN 2073679_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solaraze 3% Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains 30 mg diclofenac sodium (3% w/w). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel _Product imported from France and Italy:_ A clear, transparent, colourless or pale yellow gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of actinic keratoses 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _USE IN ADULTS: _Solaraze is applied locally to the skin 2 times daily and smoothed into the skin gently. The amount needed depends on the size of the lesion. Normally 0.5 grams (the size of a Przeczytaj cały dokument