Betamethasone's permission change is expected
By Lee, Hye-Kyung | translator Choi HeeYoung
22.04.25 06:00:26
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EMA's safety information review results
Inquiry for opinions by 6th of next month
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
Lee, Hye-Kyung(hgrace7@dailypharm.com)
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