Raptiva's benefits are modest;
in addition to PML, Raptiva is associated with other serious side effects, including Guillain-BarrÃ© and Miller-Fisher syndromes, encephalitis, encephalopathy, meningitis, sepsis and opportunistic infections (infections occurring in people with compromised immune systems);
there is not enough evidence to identify a group of patients in which the benefits of Raptiva outweigh its risks, in particular there is a lack of data on effectiveness and safety in patients who have no other treatment options and who may already have a weakened immune system as result of previous treatments.
2. The suspension of a marketing authorisation is a temporary measure, during which time a medicinal product is not available. The lifting of the suspension is conditional on the marketing authorisation holder being able to demonstrate a positive benefit-risk balance for certain groups of patients.
3. More information about Raptiva is available in the European public assessment report here: http://www.emea.europa.eu/humandocs/Humans/EPAR/raptiva/raptiva.htm.
4. This press release, together with other information on the work of the EMEA, can be found on the EMEA website: www.emea.europa.eu.