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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)
PA0966/013/001
Case No: 2043671
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ERGHA HEALTHCARE LTD
DAMASTOWN, MULHUDDART, DUBLIN 15, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BEXZIS 30 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 15/05/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 16/03/2010_
_CRN 2043671_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BexZis 30mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg of mirtazapine.
Excipients
Each tablet contains 226.66 mg lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Reddish brown, round tablets. One side of the tablet has a scoreline with the marking ”9” on one side of the scoreline
and the number ”3” on the other. The other side of the tablet is marked with the number ”7207”. The tablet can be
divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of episodes of major depression.
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