Applications for new human medicines under evaluation: February 2025

10 February 2025

Pharmacovigilance Risk Assessment Committee (PRAC): 10 - 13 February 2025, European Medicines Agency, Amsterdam, the Netherlands, from 10 February 2025 to 13 February 2025

10 February 2025

Agenda of the PRAC meeting 10-13 February 2025

10 February 2025

Human medicines European public assessment report (EPAR): Ituxredi, rituximab, Date of authorisation: 19/09/2024, Status: Authorised

10 February 2025

Product-specific bioequivalence guidance

10 February 2025

Methylphenidate, prolonged-release tablet 18 mg, 27 mg, 36 mg and 54 mg and modified release capsule 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg product-specific bioequivalence guidance

10 February 2025

Medicines for human use under evaluation

10 February 2025

List of signals discussed at PRAC since September 2012

10 February 2025

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 5 December 2024, 09:30 (CET) to 5 December 2024, 13:30 (CET)

10 February 2025

Pharmacovigilance Risk Assessment Committee (PRAC): 25 - 28 November 2024, European Medicines Agency, Amsterdam, the Netherlands, from 25 November 2024 to 28 November 2024

10 February 2025