PSUSA/00003186/202511

List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment

Retinal stimulation systems - Notified Body 0344 - 12/06/2026 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Human medicines European public assessment report (EPAR): Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), irbesartan,hydrochlorothiazide, Date of authorisation: 18/01/2007, Revision: 38, Status: Authorised

Human medicines European public assessment report (EPAR): Leflunomide medac, leflunomide, Date of authorisation: 27/07/2010, Revision: 26, Status: Authorised

Human medicines European public assessment report (EPAR): Twinrix Adult, hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed), Date of authorisation: 19/09/1996, Revision: 25, Status: Authorised

Human medicines European public assessment report (EPAR): Orblid, bevacizumab, Status: Application withdrawn

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

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