Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
FLUDARABINE PHOSPHATE
Bayer Limited
FLUDARABINE PHOSPHATE
50 Milligram
Pdr for Soln Inj/Inf
Withdrawn
2009-05-15
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1410/017/001 Case No: 2051674 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BAYER LIMITED THE ATRIUM, BLACKTHORN ROAD, DUBLIN 18, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product FLUDARABINE PHOSPHATE 50 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION 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 30/03/2009 until 01/02/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/03/2009_ _CRN 2051674_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fludarabine phosphate 50 mg powder for solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 50 mg Fludarabine phosphate. 1 ml of reconstituted solution contains 25 mg fludarabine phosphate. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion. White lyophilisate for reconstitution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of B-cell chronic lymphocytic leukaemia (CLL) in patients with sufficient bone marrow reserves. First line treatment with Fludara shou Prečítajte si celý dokument