Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
CHLOROQUINE PHOSPHATE
AstraZeneca UK Limited
250 Milligram
Tablets
1997-04-01
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 Leggi il documento completo