Change in SMPC of methotrexate

Taking into account the available evidence from the published literature, EudraVigilance, and data provided by MAH, no definite causal relationship between methotrexate and Progressive Multifocal Leukoencephalopathy has been established, but the contribution of methotrexate to the development of Progressive Multifocal Leukoencephalopathy cannot be ruled out.