Overview of comments received on the “HMA/EMA guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application (MAA) dossier” - public consultation

Aprepitant product-specific bioequivalence guidance

Human medicines European public assessment report (EPAR): Nemluvio, nemolizumab, Date of authorisation: 12/02/2025, Revision: 2, Status: Authorised

Vortioxetine hydrobromide / vortioxetine lactate product-specific bioequivalence guidance

Zonisamide product-specific bioequivalence guidance

List of medicinal products under additional monitoring

List of medicinal products under additional monitoring

List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)

Paclitaxel product-specific bioequivalence guidance

Emtricitabine/tenofovir disoproxil product-specific bioequivalence guidance