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  • Betamethasone's permission change is expected
  • by Lee, Hye-Kyung | translator Choi HeeYoung | Apr 27, 2022 06:03am
EMA's safety information review results
Inquiry for opinions by 6th of next month
As a result of reviewing safety information on drugs containing the skin disease treatment Betamethasone, precautions for use such as Pheochromocytoma are expected to be added.

The MFDS' Pharmaceutical Safety Evaluation Division prepared a change (draft) of permission based on the results of the European Medicines Agency's review of safety information on drugs containing "Betamethasone." This change includes both Betamethasone PO and Betamethasone Inj.

"Pheochromocytoma, which could be fatal, were reported after administration of systemic corticosteroids. Patients suspected or confirmed to have Pheochromocytoma should be administered only after evaluating the appropriate risk and benefit of Corticosteroids.'

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