European Commission revokes marketing authorisation for Novartis’ crizanlizumab
European Pharmaceutical Review
AUGUST 11, 2023
Novartis said the decision to revoke the authorisation was based on a review of crizanlizumab under Article 20 of Regulation (EC) No 726/2004. However, the STAND results did not suggest new safety concerns with crizanlizumab. EMA required the STAND study as part of the marketing authorisation.
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