EMA recommendations to deal with sterility concerns for DepoCyte

The European Medicines Agency last Friday agreed a number of precautionary measures to deal with manufacturing deficiencies which could affect the sterility of DepoCyte (cytarabine), an anti-cancer medicine used to treat lymphomatous meningitis, which is produced by US drugmaker Pacira Pharmaceuticals and marketed in Europe by Sigma Tau and Mundipharma.

These measures are intended to protect patients from potentially harmful effects, while they also allow continued access to treatment for patients who have no suitable alternatives. DepoCyte has been authorized in the European Union since July 2001 and is marketed in Austria, Belgium, Bulgaria, the Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Sweden and the UK, as well as Iceland and Norway.

To be recalled where suitable alternatives available