Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders and changes to scope of European safety referrals

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Amendments of the European Union (EU) pharmacovigilance legislation that were adopted in October 2012 came into force on Monday 28 October 2013. These changes, which cover various aspects of the legislation, aim to further strengthen the protection of patient health by increasing the ability of the European medicines network to take prompt and appropriate regulatory action.

Two new indications of Velcade® approved for use across Europe

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The European Commission granted a licence for the use of two new indications of Velcade® (bortezomib) in the treatment of myeloma. It has approved its use as an induction treatment for newly diagnosed patients prior to high-dose therapy and autologous stem cell transplantation and as a retreatment in relapsed myeloma patients (in combination with thalidomide and dexamethasone) who have previously responded well to Velcade®.

CHMP positive opinion on Pomalidomide

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The Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) has adopted a positive opinion, recommending the granting of a marketing authorisation for Pomalidomide (Pomalidomide Celgene®) in the treatment of multiple myeloma for relapsed and refractory myeloma patients. The next step is for the European Commission to adopt the final licensing decision within three months. There is no doubt that this is a crucial step for patients within the EU…

Subcutaneous Velcade® approved for use across Europe

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MPE has welcomed the news today that the European Commission has approved a marketing licence for Velcade to be used as a subcutaneous (under the skin) injection for myeloma patients. Velcade was the first in a class of anti-cancer drugs called proteasome inhibitors to be used in myeloma. It was first licensed in Europe in an IV formulation and since then Velcade has had a significant impact on the treatment of myeloma.