Human medicines European public assessment report (EPAR): Polivy, polatuzumab vedotin, Date of authorisation: 16/01/2020, Revision: 7, Status: Authorised
Start of Union reviews adopted during the CHMP meeting of 13-16 October 2025
Summary of opinion: Paxlovid, 16/10/2025 Positive
Orphan designation: 2-(3-(4-(1H-Indazol-5-ylamino)quinazolin-2-yl)phenoxy)-N-isopropylacetamide-methane sulfonic acid salt Treatment of graft-versus-host disease, 17/10/2019 Positive
First treatment for serious chronic lung disease
Opinion/decision on a Paediatric investigation plan (PIP): Rezzayo, rezafungin acetate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0343/2024
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 October 2025
Summary of opinion: Libtayo, 16/10/2025 Positive
Summary of opinion: Breyanzi, 16/10/2025 Positive
Summary of opinion: Gazyvaro, 16/10/2025 Positive