Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
CABERGOLINE
Norton Waterford
CABERGOLINE
1 Milligram
Tablets
Product subject to prescription which may not be renewed (A)
Withdrawn
0000-00-00
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0436/044/001 Case No: 2080172 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NORTON WATERFORD T/A IVAX PHARMACEUTICALS IRELAND, UNIT 301, IDA INDUSTRIAL PARK, CORK ROAD, WATERFORD, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product EFLAVEX 1 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 29/03/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/03/2010_ _CRN 2080172_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eflavex 1 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg cabergoline. Excipient: lactose 75.3 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet The tablet can be divided into equal halves. White, oval-shaped, biconvex tablets containing 1 mg cabergoline. Each tablet is scored on both sides and has ‘CBG’ and ‘1’ on the other side of the breakline. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _TREATMENT OF PARKINSON’S DISEASE:_ If treatment with a dopamine agonist is being considered, cabergoline is indicated as secon Przeczytaj cały dokument