Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
DACARBAZINE
HOSPIRA UK Ltd
200 Milligram
Pdr for Soln for Injection
1998-05-15
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0437/040/002 Case No: 2072705 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to HOSPIRA UK LTD QUEENSWAY, ROYAL LEAMINGTON SPA, WARWICKSHIRE CV31 3RW, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product DACARBAZINE 200MG 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 15/01/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/01/2010_ _CRN 2072705_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dacarbazine 200mg Powder for Solution for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 200mg of dacarbazine. When reconstituted as directed in sections 4.2 and 6.6, each ml of medicinal solution contains 10mg of dacarbazine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection. White or very pale yellow powder or plug. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Metastatic malignant melanoma 2. Solid tumours 3. Hodgkin's disease In addition, dacarbazine has been shown, when used in combination with other a Preberite celoten dokument