Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
ROPINIROLE
GlaxoSmithKline (Ireland) Limited
0.50 Milligram
Film Coated Tablet
2006-12-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1077/107/002 Case No: 2030387 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to GLAXOSMITHKLINE (IRELAND) LTD STONEMASONS WAY, RATHFARNHAM, DUBLIN 16, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product VUNEXIN 0.5MG FILM-COATED 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 29/08/2007 until 30/11/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 02/09/2007_ _CRN 2030387_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vunexin 0.5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0.5 mg of ropinirole (as hydrochloride). Excipient(s): Lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow oval-shaped, marked "GS" on one side and "TES" on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VUNEXIN is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use. Adults Individual dose titration against efficacy and Læs hele dokumentet