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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)
PA0970/029/001
Case No: 2060697
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ASTRAZENECA UK LIMITED
600 CAPABILITY GREEN, LUTON, LU1 3LU, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
AVLOCLOR TABLETS 250 MG
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 30/01/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 30/01/2009_
_CRN 2060697_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Avloclor Tablets 250 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg chloroquine phosphate which is equivalent to 155 mg chloroquine base.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
Avloclor Tablets are white in colour, round, biconvex with a breakline and on either side of the line an ‘A’ intagliation
is present. The reverse face of the tablet is plain.
The breakline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
a)
Treatment of malaria.
b)
Prophylaxis and suppress
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