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 changed.
respectively.
In view of the available data on abortion from clinical trials, literature, and spontaneous reports, PRAC believes that a causal relationship between glatiramer and abortion is unlikely. PRAC concluded that information about products containing glatiramer should be changed accordingly.
