Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
BRIMONIDINE TARTRATE
Rowex Ltd
0.2 Per Cent
Eye Drops Solution
2007-10-12
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0711/119/001 Case No: 2073375 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ROWEX LTD BANTRY, CO. CORK, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product BRIMON 2 MG/ML 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 20/05/2010 until 11/10/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/05/2010_ _CRN 2073375_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Brimon 2 mg/ml Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 2 mg brimonidine tartrate (equivalent to brimonidine base 1.3 mg/ml). Excipient(s): Benzalkonium chloride 0.05 mg/ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless to yellowish solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension. - As monotherapy in patients in whom topical beta-blocker therapy is contraindicated. - As adjunctive therapy to other intraocular pressure lower Soma hati kamili