Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
PREDNISOLONE SODIUM PHOSPHATE
Chauvin Pharmaceuticals Limited
PREDNISOLONE SODIUM PHOSPHATE
0.5 %w/v
Eye Drops Solution
Product subject to prescription which may not be renewed (A)
Authorised
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) PA0118/027/001 Case No: 2027257 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CHAUVIN PHARMACEUTICALS LIMITED 106 LONDON ROAD, KINGSTON-UPON-THAMES, SURREY, KT2 6TN, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product MINIMS PREDNISOLONE SODIUM PHOSPHATE 0.5% W/V EYE DROPS, 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 18/02/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/11/2007_ _CRN 2027257_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minims Prednisolone Sodium Phosphate 0.5% w/v Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Prednisolone sodium phosphate 0.5 % w/v. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution Clear, colourless, aqueous, single-use eye drops, solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non-infected inflammatory conditions of the eye. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and the elderly One or two drops applied topically to the eye as required. Children At the discretion of the physician. 4.3 C সম্পূর্ণ নথি পড়ুন