国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
FLUOROMETHOLONE
Allergan Pharmaceuticals Ireland
FLUOROMETHOLONE
2.5 Micromol
Eye Drops Suspension
Product subject to prescription which may be renewed (B)
Withdrawn
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) PA0148/007/002 Case No: 2049159 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 FORTE LIQUIFILM 2.5 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 15/04/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 17/04/2008_ _CRN 2049159_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT FML Forte Liquifilm 2.5 mg/ml eye drops, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients: Benzalkonium chloride 0.05mg/ml For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, suspension Sterile, white, microfine suspension.. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FML Forte is indicated for corticosteroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over the age of 2 years only: Instill one drop into the conjunctival sac two to 完全なドキュメントを読む