국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
CABERGOLINE
Norton Waterford
CABERGOLINE
4 Milligram
Tablets
Product subject to prescription which may not be renewed (A)
Withdrawn
2008-12-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0436/044/003 Case No: 2036252 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NORTON WATERFORD LIMITED T/A IVAX PHARMACEUTICALS IRELAND, IDA INDUSTRIAL PARK, WATERFORD, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product EFLAVEX 4 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 09/07/2008 until 28/02/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/07/2008_ _CRN 2036252_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eflavex 4 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg cabergoline. Excipient: lactose 301.2 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, biconvex tablets with scores on both sides. One side is debossed with ‘CBG’ and ‘4’ 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, eflavex is indicated as second line therapy in patients who are 전체 문서 읽기