Glatiramer — Scientific Conclusions and Basis for Modification of Registration Approval Terms — PSUSA-00001529-202011


In view of the available evidence of severe liver damage from clinical trials and spontaneous reports, including in some cases a close temporal relationship, positive withdrawal, and/or re-challenge, PRAC believes that a causal relationship between glatiramer and severe liver damage has been established. . PRAC concluded that the information about products containing glatiramer should be [...]