País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
CARTEOLOL HYDROCHLORIDE
Chauvin Pharmaceuticals Limited
CARTEOLOL HYDROCHLORIDE
1 %w/v
Eye Drops Prolonged Rel.
Withdrawn
2009-07-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0118/048/001 Case No: 2043927 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 FORTINOL LA 1 %W/V EYE DROPS PROLONGED REL. 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 28/11/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/11/2007_ _CRN 2043927_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fortinol LA 1%, Eye drops, prolonged-release. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Carteolol hydrochloride: 1 g per 100 ml (1 ml eye drops, prolonged release contains Carteolol hydrochloride 10 mg). Excipient: benzalkonium chloride solution (10 mg/100 ml). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, prolonged-release. Clear and light brown yellow solution . The pH is between 6 and 7, compatible with the pH of the tears. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS o Intraocular hypertension. o Chronic open-angle glaucoma. 4.2 POSOLOGY A Llegiu el document complet