Scientific recommendations on classification of advanced therapy medicinal products

Appendix 1: Acceptable intakes established for N-nitrosamines

Information Management

Herbal medicinal product: Malvae sylvestris flosArray, F: Assessment finalised

Human medicines European public assessment report (EPAR): Pelmeg, pegfilgrastim, Date of authorisation: 20/11/2018, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Noxafil, posaconazole, Date of authorisation: 25/10/2005, Revision: 38, Status: Authorised

Human medicines European public assessment report (EPAR): Teriflunomide Accord, teriflunomide, Date of authorisation: 09/11/2022, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Byooviz, ranibizumab, Date of authorisation: 18/08/2021, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Pluvicto, lutetium (177Lu) vipivotide tetraxetan, Date of authorisation: 09/12/2022, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): RotaTeq, rotavirus vaccine, live, Date of authorisation: 26/06/2006, Revision: 37, Status: Authorised