Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
PREDNISOLONE ACETATE SULFACETAMIDE SODIUM PHENYLEPHRINE HYDROCHLORIDE
Allergan Pharmaceuticals Ireland
0.22/10.3 %w/v
Eye Drops Suspension
1977-04-01
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0148/021/001 Case No: 2031031 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ALLERGAN PHARMACEUTICALS IRELAND CASTLEBAR ROAD, WESTPORT, CO. MAYO, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product BLEPHAMIDE LIQUIFILM TOPICAL OPTHALMIC SUSPENSION 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 21/12/2006 until 31/03/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/12/2006_ _CRN 2031031_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Blephamide LiquifilmTopical Ophthalmic Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For excipients, see 6.1 3 PHARMACEUTICAL FORM Eye Drops Suspension An off-white to slightly yellow, microfine suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of nonpurulent blepharitis and blepharoconjunctivitis (seborrheal, staphylococcal, allergic), and nonpurulent conjunctivitis (allergic and bacterial). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One drop two to four times daily, depending upon the severity of the condition. In general, during early or acute stages of blepharitis, Blephamide produces resu Preberite celoten dokument