DONELINN 10 MG FILM-COATED TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
06-06-2024
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Active ingredient:
DONEPEZIL HYDROCHLORIDE
Available from:
Helsinn Birex Therapeutics Ltd
Dosage:
10 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2009-09-11
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0915/020/002
Case No: 2045697
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
HELSINN BIREX THERAPEUTICS LTD
DAMASTOWN, MULHUDDART, DUBLIN 15, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
DONELINN 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 11/09/2009 until 10/09/2014.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/09/2009_
_CRN 2045697_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Donelinn 10mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of donepezil hydrochloride respectively.
Excipients include: Lactose 194.70mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
Pale yellow, round, biconvex film-coated tablets, 9 mm in diameter and marked DZ 10 on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Donelinn tablets are indicated for the symptomatic treatment of mild or moderate dementia in Alzheimer's disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults/elderly_
The initial dose is 5 mg
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