Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
BETAMETHASONE SODIUM PHOSPHATE NEOMYCIN SULFATE
UCB Pharma Limited
BETAMETHASONE SODIUM PHOSPHATE NEOMYCIN SULFATE
0.1/0.5%w/ %v/v
Eye Ointment
Product subject to prescription which may not be renewed (A)
Withdrawn
0000-00-00
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0365/046/002 Case No: 2077742 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to UCB PHARMA LIMITED 208 BATH ROAD, SLOUGH, BERKSHIRE SL1 3WE, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product BETNESOL - N 0.1% / 0.5% EYE OINTMENT 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 10/02/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/02/2010_ _CRN 2077742_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betnesol - N 0.1% / 0.5% Eye Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Betamethasone Sodium Phosphate 0.10% w/w Neomycin Sulphate 0.50% w/w (equivalent to 3500 IU/g) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye ointment A smooth off-white translucent ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the short-term treatment of steroid responsive inflammatory conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of viral and fungal disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (including the elde Прочитать полный документ