Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
DONEPEZIL HYDROCHLORIDE MONOHYDRATE
Niche Generics Limited
10 Anhyd Milligrams
Film Coated Tablet
2010-05-28
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1063/036/002 Case No: 2059594 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NICHE GENERICS LIMITED 1, THE CAM CENTRE, WILBURY WAY, HITCHIN, HERTFORDSHIRE SG4 OTW, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product ARIZIME 10MG FILM-COATED TABLETS 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 28/05/2010 until 27/05/2015. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 01/06/2010_ _CRN 2059594_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arizime 10mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10mg donepezil hydrochloride (as the monohydrate), equivalent to 9.12mg of donepezil For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet White or almost white, round, biconvex film-coated tablets embossed with stylized ‘E382’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Arizime is indicated for the symptomatic treatment of mild to moderately severe Alzheimer’s dementia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adu Lees het volledige document