publicEuropean Medicines Agency · European Union · Updated Jul 10, 2026
PRAC 6-9 July 2026: Agrees new safety information on desogestrel- and etonogestrel-containing contraceptives and Litfulo, a medicine to treat alopecia areata News Human Pharmacovigilance Download medicine d
MAHs must execute safety communication plans, update Risk Management Plans (RMPs), and revise product information including the Summary of Product Characteristics (SmPC) and Package Leaflet.
Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact3 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead, Labeling Lead
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