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Product information must be amended to include warnings about misuse of dimenhydrinate, particularly among adolescents and young adults, as well as potential risks of Stevens-Johnson syndrome and fixed drug eruptions.
These changes are essential to ensure that safety information accurately reflects the risks associated with the product, thus protecting public health.
Implement the updated product information by November 5, 2026, ensuring that all labeling and documentation includes the new warnings and risk profiles.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Implement the updated product information by November 5, 2026, ensuring that all labeling and documentation includes the new warnings and risk profiles.
The European Medicines Agency (EMA) has issued a periodic safety update report (PSUSA) that requires changes to product information for caffeine/dimenhydrinate regarding misuse, Stevens-Johnson syndrome, and fixed drug eruption risks.
What changed: Product information must be amended to include warnings about misuse of dimenhydrinate, particularly among adolescents and young adults, as well as potential risks of Stevens-Johnson syndrome and fixed drug eruptions.
Why it matters: These changes are essential to ensure that safety information accurately reflects the risks associated with the product, thus protecting public health.
Practical implication: Implement the updated product information by November 5, 2026, ensuring that all labeling and documentation includes the new warnings and risk profiles.
Published from the regulator source ingestion pipeline after PV impact triage.
Monitor and evaluate the drug misuse trends and health impacts associated with ketamine, focusing on the increase in seizures as part of public health and law enforcement strategies.
Implement new labeling requirements for choline salicylate products by November 5, 2026, including specific warnings as outlined.
The marketing authorization holder must submit amended product information reflecting the new safety guidelines by October 9, 2026, with translations due by August 10, 2026.
Update labeling to reflect the new indication for Stelara, and ensure compliance with associated regulatory activities including safety monitoring.
