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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)
PPA1473/040/001
Case No: 2071611
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MCDOWELL PHARMACEUTICALS
4 ALTONA ROAD, LISBURN, N. IRELAND, BT27 5QB
an authorisation, subject to the provisions of the said Regulations, in respect of the product
KLACID LA 500MG MODIFIED RELEASE 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 05/02/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/02/2010_
_CRN 2071611_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Klacid LA 500mg Modified Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Clarithromycin 500mg
Excipients- contains Lactose Monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified Release Tablet
_Product imported from the UK:_
Yellow, ovaloid modified release tablet
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Klacid LA is indicated for treatment of infections caused by susceptible organisms.
Indications include:
Lower respiratory tract infections for example bronchitis and pneumonia.
Upper respiratory tract infections for example sinusitis and pharyngiti
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