Pharmacovigilance Updates: Imatinib approved for use in the EU

The EMC’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib Actavis showed comparable quality and bioequivalence to the already approved Glivec.

Pharmacovigilance Update: Imatinib approved for use in the European Union.

• Report Date: 28/01/2019
• Active Substance: Imatinib (Actavis)
• Diseases targeted: chronic myeloid leukemia (CML), Ph+ acute lymphoblastic leukemia (ALL), myelodysplastic or myeloproliferative diseases (MD/MPD), advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukemia (CEL), dermatofibrosarcoma protuberans (DFSP).
• Availability: Capsules (50, 100 and 400 mg), tablets (100 and 400 mg)
• Ground for Approval/Rejection: The EMC’s  Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib Actavis showed comparable quality and bioequivalence to the already approved Glivec.
• More information about this update here.

About the esanum’s Pharmacovigilance Updates

This section gives our users summaries from the European Union’s pharmacovigilance system, the European Medicines Agency, and other sources providing European Public Assessments Reports. They provide concise and up-to-date information on approved and approval-pending medicines across therapeutic areas. 
For more information, please visit the EMA’s updates here