দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
CROMOGLICATE SODIUM
Freynes & Co Limited
CROMOGLICATE SODIUM
2 %w/v
Ear/Eye Drops, solution
Product not subject to medical prescription
Withdrawn
2010-07-11
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1640/001/001 Case No: 2078436 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA0141/029/001. FREYNES & CO LIMITED ORCHARD ROAD, CLONDALKIN, DUBLIN 22, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product SODIUM CROMOGLICATE EYEDROPS, 2 %W/V 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 05/03/2010 until 11/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/03/2010_ _CRN 2078436_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sodium Cromoglicate Eyedrops 2% w/v 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 20.0 mg of sodium cromoglicate. ( 2% w/v ) For excipients, see 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. Colourless to slightly yellow, clear, aqueous eye drops solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention and treatment of acute or chronic allergic conjunctivitis and vernal kerato-conjunctivitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For ocular use. Adults (including the elderly) and children: One drop into each eye four times daily সম্পূর্ণ নথি পড়ুন