ARIZIME 10 Anhyd Milligrams Film Coated Tablet

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

DONEPEZIL HYDROCHLORIDE MONOHYDRATE

제공처:

Niche Generics Limited

INN (International Name):

DONEPEZIL HYDROCHLORIDE MONOHYDRATE

복용량:

10 Anhyd Milligrams

약제 형태:

Film Coated Tablet

처방전 유형:

Product subject to prescription which may not be renewed (A)

승인 상태:

Withdrawn

승인 날짜:

2012-11-09

제품 특성 요약

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