País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE HYDROXYETHYLCELLULOSE
Chauvin Pharmaceuticals Limited
0.35 + 0.4 %w/w
Eye Drops Solution
1992-03-23
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0118/043/001 Case No: 2071966 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 ARTIFICIAL TEARS 0.35% W/W 0.44% W/W 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 19/11/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/11/2009_ _CRN 2071966_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minims Artificial Tears 0.35% w/w + 0.44% w/w Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hyetellose Ph. Eur. 0.44 % w/w and sodium chloride Ph. Eur. 0.35 % w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution Sterile, single use eye drops, solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of dry eye syndromes associated with deficient tear secretion. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One or two drops instilled into the affected eye three or four times daily, or as often as is required Leer el documento completo