Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Orion Corporation
0.7 Milligram
Tablets
2010-03-19
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1327/012/004 Case No: 2049379 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ORION CORPORATION ORIONINTIE 1, FI-02200 ESPOO, FINLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product PRAMIPEXOLE ORION 0.7 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 19/03/2010 until 18/03/2015. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/05/2010_ _CRN 2049379_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pramipexole Orion 0.7 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Pramipexole Orion 0.7 mg tablets contain 0.7 mg of pramipexole base For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Whte, round, flat, scored on one side tablets (diameter: 9mm approximately). The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pramipexole Orion is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodo Baca dokumen lengkap