국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
CABERGOLINE
Norton Waterford
CABERGOLINE
2 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Withdrawn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) PA0436/044/002 Case No: 2078465 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, 2 MILLIGRAM 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 09/02/2010. 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 2078465_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eflavex 2 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg cabergoline. Excipient: lactose 150.6 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet The tablet can be divided into equal halves. White, capsule-shaped, biconvex tablets with scores on both sides. One side is debossed with ‘CBG’ and ‘2’ on either side of the score. 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 second line therapy in patien 전체 문서 읽기