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Regulatorische Updates

Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit

#adverse reactions ×

UPDATED
Regulatorische Updates
18. Sept. 2026•1 Min. Lesezeit
MFDS to Add Stevens-Johnson Syndrome to Labels of 56 Oral Aripiprazole Products
South Korea’s MFDS will amend the approval conditions for 56 oral aripiprazole medicines, adding Stevens-Johnson syndrome as a reported adverse reaction. The change involves 12 manufacturers.
UPDATED
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
MFDS Issues Draft Amendment Order for Opicapone Oral Formulations to Update Adverse Reaction Precautions
The Korean Ministry of Food and Drug Safety has prepared a draft amendment order for Opicapone oral drugs, revising the adverse‑reaction warnings and opening a public comment period.
UPDATED
Regulatorische Updates
24. Aug. 2026•1 Min. Lesezeit
MHRA reminds of serious amiodarone risks and need for patient monitoring
Amiodarone linked to life‑threatening lung, liver and thyroid side effects; MHRA urges healthcare professionals to supervise and review patients.