País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
MITOMYCIN
Kyowa Hakko Kirin UK Ltd
MITOMYCIN
20 Milligram
Pdr for Soln for Injection
Withdrawn
2008-07-01
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0892/001/003 Case No: 2036657 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to KYOWA HAKKO UK LIMITED 258 BATH ROAD, SLOUGH, BERKSHIRE, SL1 4DX, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product MITOMYCIN-C KYOWA 20 MG, POWDER FOR SOLUTION FOR INJECTION 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 24/05/2007 until 12/12/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/08/2007_ _CRN 2036657_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mitomycin-C Kyowa 20 mg, Powder for Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 20 mg of Mitomycin-C. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection Blue/purple crystalline powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mitomycin C must be used under supervision of an Oncologist. 1. As a single agent in the treatment of superficial bladder cancer. In addition it has been shown that post-operative instillations of Mitomycin-C Kyowa can reduce recurrence rates in newly diagnosed patients with superficial bladder Leia o documento completo