DONEPEZIL SYNTHON
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-03-2023
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Active ingredient:
DONEPEZIL HYDROCHLORIDE MONOHYDRATE
Available from:
Synthon BV
Dosage:
5 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2008-05-02
Summary of Product characteristics
License
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
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