I wrote the EMA and this is the answer I got back:Dear Mr
Thank you for your query of 19 November 2013 regarding an on-going procedure for Mabthera.
A revised version of the Risk Management Plan (RMP) for this product will be discussed at the Pharmacovigilance Risk Assessment Committee (PRAC) meeting in January; the minutes of this meeting will be published on the European Medicines Agency’s (EMA) website around mid-February:
Please note that the EMA is not able to comment further on the status of on-going evaluations until such evaluation is concluded.
We hope you find this information helpful.
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Update of section 4.4 of the SmPC in order to strengthen the warning regarding prevention of Hepatitis B reactivation.
C.I.4 - Variations related to significant modifications of the SPC due in particular to new quality, pre-clinical, clinical or pharmacovigilance data
Title Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 January 2014
Date 06/01/2014 - 09/01/2014
Location European Medicines Agency, London, UK
Summary The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use.