Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
NAPHAZOLINE HYDROCHLORIDE
Allergan Pharmaceuticals Ireland
1mg/ml Mg/Ml
Eye Drops Solution
1982-11-01
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0148/016/001 Case No: 2077287 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 ALBALON 1 MG/ML LIQUIFILM EYE DROPS SOLUTION the particulars of which are set out in 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 25/08/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/08/2010_ _CRN 2077287_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ALBALON 1 mg/ml Liquifilm Eye Drops Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Naphazoline hydrochloride 1mg/ml (0.1% w/v) Excipients: contains Benzalkonium chloride 0.04mg/ml (0.004% w/v) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless to straw-coloured sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ALBALON is indicated for use as a topical ocular vasoconstrictor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults only: the usual dose is one or two drops 3 to 4 hours or as instructed by the physician. Method of Administration: topical into the c Prečítajte si celý dokument