Comirnaty : Periodic safety update report assessment: 19 December 2021 to 18 June 2022

Human medicines European public assessment report (EPAR): Tolvaptan Accord, tolvaptan, Inappropriate ADH Syndrome, Status: Authorised

EMA mourns passing of Noël Wathion

Orphan designation: 4-Amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride (ronopterin), Treatment of moderate and severe traumatic brain injury, 28/08/2006, Positive

Human medicines European public assessment report (EPAR): Mircera, methoxy polyethylene glycol-epoetin beta, Anemia;Kidney Failure, Chronic, Date of authorisation: 20/07/2007, Revision: 29, Status: Authorised

Human medicines European public assessment report (EPAR): Bonviva, ibandronic acid, Osteoporosis, Postmenopausal, Date of authorisation: 23/02/2004, Revision: 29, Status: Authorised

Human medicines European public assessment report (EPAR): Trodelvy, sacituzumab govitecan, Breast Neoplasms;Triple Negative Breast Neoplasms, Date of authorisation: 22/11/2021, Revision: 3, Status: Authorised

EMA business hours over Assumption Day, 15 August