Summary of opinion: Tecvayli, 17/09/2026 Positive
Summary of opinion: Tecvayli, 17/09/2026 Positive
Summary of opinion: Tecvayli, 17/09/2026 Positive
Summary of opinion: Sogroya, 17/09/2026 Positive
Withdrawn application: Alhemo, 10/09/2026
Referral: Sodium oxybate-containing syrup and oral solution for alcohol dependence, sodium oxybate Article 31 referrals CHMP opinion, 17/09/2026, 18/09/2026
Referral: Ipidacrine-containing medicinal products, ipidacrine Article 31 referrals CHMP opinion, 17/09/2026, 18/09/2026
Summary of opinion: Keytruda, 17/09/2026 Positive
Veterinary good pharmacovigilance practices (VGVP)
Draft guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management - Revision 1
Summary of opinion: Padcev, 17/09/2026 Positive
Antimicrobial Sales and Use (ASU) - Use data template