País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
ROPINIROLE (AS HYDROCHLORIDE)
Pliva Pharma Limited
2.0 Milligram
Film Coated Tablet
2008-12-12
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0585/032/004 Case No: 2039486 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PLIVA PHARMA LIMITED VISION HOUSE, BEDFORD ROAD, PETERSFIELD, HAMPSHIRE GU32 3QB, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product EIRONIL 2MG 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 12/12/2008 until 11/12/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 17/12/2008_ _CRN 2039486_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eironil 2mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 mg film-coated tablet contains 2.0 mg of ropinirole (as hydrochloride). Excipient(s): Each 2 mg film-coated tablet contains 62.083mg of lactose (as monohydrate) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet White round biconvex film coated tablet debossed with 'RO' on one side and '2' on the other side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Parkinson's disease under the following conditions: Initial treatment as monotherapy, in order to Leia o documento completo