Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
NEOMYCIN SULFATE FLUOROMETHOLONE
Allergan Pharmaceuticals Ireland
1/5 Mg/Ml
Eye Drops Suspension
1976-05-18
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0148/020/001 Case No: 2053297 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 FML-NEO LIQUIFILM 1MG/ML + 5 MG/ML EYE DROPS, 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 12/08/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/08/2008_ _CRN 2053297_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT FML-NEO Liquifim 1 mg/ml + 5 mg/ml eye drops, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Eye drops, suspension White to slightly straw-coloured microfine suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FML-NEO is indicated for use in the following situations: In the treatment of infectious conjunctivitis due to organisms sensitive to neomycin. For the treatment of corneal and anterior segment inflammatory disorders which may be threatened with, or complicated by, organisms sensitive to neomycin. Prophylactically following removal of foreign bodies, as Lire le document complet