Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LEVODOPA BENSERAZIDE HYDROCHLORIDE
Roche Products Ltd
100/25 Milligram
Capsules Hard
1979-04-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0050/043/001 Case No: 2056944 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ROCHE PRODUCTS LTD 6 FALCON WAY, SHIRE PARK, WELWYN GARDEN CITY, AL7 1TW, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product MADOPAR 100MG/25MG HARD CAPSULES 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 01/04/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 04/04/2009_ _CRN 2056944_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Madopar 100mg/25mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100.0 mg levodopa and 25 mg benserazide (as benserazide hydrochloride). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, hard (Capsules) Pale pink opaque body and a powder blue opaque cap, imprinted with the name ‘Roche’ in black ink on both sections. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of Parkinsonism of idiopathic, post-encephalitic or arteriosclerotic type. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS OVER THE AGE OF 25 YEARS O Read the complete document