Appendix 1: Acceptable intakes established for N-nitrosamines

Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka, emtricitabine,tenofovir disoproxil, Date of authorisation: 09/12/2016, Revision: 14, Status: Authorised

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

Clinical Trial Information System (CTIS) - Sponsor handbook

International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

Human medicines European public assessment report (EPAR): Lenalidomide Accord, lenalidomide, Date of authorisation: 20/09/2018, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Ozurdex, dexamethasone, Date of authorisation: 26/07/2010, Revision: 20, Status: Authorised

European Medicines Agency's data protection notice for the HMA-EMA Catalogue of real-world data sources (and networks and institutions)

European Medicines Agency’s data protection notice for the HMA-EMA Catalogue of real-world data studies

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2024