EMA's PRAC starts a new safety review, extends scope of antiviral review

15 April 2016

In April, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) started a new safety review and extended the scope of an ongoing review procedure.

The PRAC has started a review of the diabetes medicine canagliflozin after an increase in amputations mostly affecting toes was observed in an ongoing clinical trial called CANVAS. Canagliflozin is the active substance in two centrally authorized diabetes medicines, Invokana and Vokanamet (which also contains metformin), both from Johnson & Johnson (NYSE: JNJ) subsidiary Janssen.

PRAC extends the scope of its review on direct-acting antivirals for hepatitis C

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