Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
ALLOPURINOL
McDermott Laboratories Ltd t/a Gerard Laboratories
300 Milligram
Tablets
1996-12-13
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0577/013/002 Case No: 2031808 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MCDERMOTT LABORATORIES LTD T/A GERARD LABORATORIES 35/36 BALDOYLE INDUSTRIAL ESTATE, GRANGE ROAD, DUBLIN 13, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product ALLOPURINOL 300 MG 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 05/12/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/12/2007_ _CRN 2031808_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Allopurinol 300 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg allopurinol. Excipients: Lactose monohydrate For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. Round, biconvex, white tablets with breakline. ‘ALL 300’ on one side and twin triangle logo on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Allopurinol is indicated for reducing urate/uric acid formation in conditions where urate/uric acid deposition has already occurred (e.g. gouty arthritis, skin tophi, nephrolithiasis) or is a predictable clinical r Lees het volledige document