Orphan designation: recombinant human surfactant protein D Prevention of bronchopulmonary dysplasia, 11/04/2014 Positive

Enpr-EMA priority activities

Meeting summary - Medicine Shortages SPOC Working Party meeting 16-17 June 2026

Orphan designation: autologous CD4+ and CD8+ T cells transduced with lentiviral vector containing an affinity-enhanced T-cell receptor targeting the New York esophageal antigen-1 Treatment of soft tissue sarcoma, 14/07/2016 Positive

Silapo : EPAR - All Authorised presentations

Human medicines European public assessment report (EPAR): Clopidogrel Zentiva (previously Clopidogrel Winthrop), clopidogrel, Date of authorisation: 15/07/2008, Revision: 35, Status: Authorised

Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Date of authorisation: 22/11/2018, Revision: 25, Status: Authorised

Human medicines European public assessment report (EPAR): Lytenava, bevacizumab, Date of authorisation: 27/05/2024, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Opzelura, ruxolitinib, Date of authorisation: 19/04/2023, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Palsonify, paltusotine, Date of authorisation: 23/04/2026, Revision: 2, Status: Authorised