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IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0585/037/002
Case No: 2044816
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PLIVA PHARMA LIMITED
VISION HOUSE, BEDFORD ROAD, PETERSFIELD, HAMPSHIRE GU32 3QB, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ESCITALOPRAM 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 28/05/2009 until 27/05/2014.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/05/2009_
_CRN 2044816_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Escitalopram 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg escitalopram (as oxalate)
Excipients: Each film-coated tablet contains 0.53 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, round, biconvex film-coated tablet. On one side there is a breaking line, on the other side a N54 mark is
engraved. The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
Treatment of panic
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