Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
DONEPEZIL HYDROCHLORIDE MONOHYDRATE
Synthon BV
5 Milligram
Film Coated Tablet
2008-05-02
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0840/007/001 Case No: 2076683 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SYNTHON B.V. MICROWEG 22, 6545 CM NIJMEGEN, NETHERLANDS an authorisation, subject to the provisions of the said Regulations, in respect of the product DONEPEZIL SYNTHON 5 MG 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 22/04/2010 until 01/05/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/04/2010_ _CRN 2076683_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Donepezil Synthon 5 mg film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5.22 mg donepezil hydrochloride monohydrate, equivalent to 5 mg donepezil hydrochloride, equivalent to 4.56 mg of donepezil. Excipient: Each tablet contains 91 mg lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, round, biconvex, film-coated tablets, debossed with D9EI on one side and 5 on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Donepezil hydrochloride is indicated for the symptomatic treatment of mild to moderately Baca dokumen lengkap