GALANTAMINE TEVA
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
22-03-2023
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Active ingredient:
GALANTAMINE
Available from:
Teva Pharma B.V.
Dosage:
4 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2007-12-19
Summary of Product characteristics
License
IRISH MEDICINES BOARD ACT 1995, as amended
Medicinal Products (Control of Placing on the Market) Regulations, 2007, as amended
PA0749/022/001
Case No: 2082897
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Teva Pharma B.V.
Computerweg 10, 3542 DR Utrecht, Netherlands
an authorisation, subject to the provisions of the said Regulations, in respect of the product
Galantamine Teva 4mg Film-coated Tablets
the particulars of which are set out in 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 01/09/2010 until 18/12/2012.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
Irish Medicines Board
______________________________________________________________________________________________________________________
Date Printed 01/09/2010
CRN 2082897
page number: 1
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Galantamine Teva 4mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 4
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