Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
CARTEOLOL HYDROCHLORIDE
Novartis Pharmaceuticals UK Ltd
CARTEOLOL HYDROCHLORIDE
2 %w/v
Eye Drops Solution
Withdrawn
2009-01-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0013/102/002 Case No: 2040186 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NOVARTIS PHARMACEUTICALS UK LTD FRIMLEY BUSINESS PARK, FRIMLEY, CAMBERLEY, SURREY, GU16 7SR, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product TEOPTIC 2 %W/V EYE DROPS SOLUTION 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 30/08/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 02/09/2007_ _CRN 2040186_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Teoptic 2% w/v Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Carteolol hydrochloride 2 % w/v. Excipients: Benzalkonium chloride 0.005% w/v. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the reduction of intraocular pressure e.g. in ocular hypertension, chronic open angle glaucoma, some secondary glaucomas. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults including the elderly: Initially one drop of 1% eye drops instilled twice daily in each affected e Soma hati kamili