CHMP opinions on consultation procedures

Opinion on medicine for use outside EU: Aluvia, lopinavir,ritonavir, HIV Infections, 21/09/2006 Positive opinion

Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine,elasomeran,elasomeran / imelasomeran,elasomeran / davesomeran,andusomeran, COVID-19 virus infection, Date of authorisation: 06/01/2021, Revision: 41, Status: Authorised

Human medicines European public assessment report (EPAR): Gavreto, pralsetinib, Carcinoma, Non-Small-Cell Lung, Date of authorisation: 18/11/2021, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Epoetin Alfa Hexal, epoetin alfa, Anemia;Kidney Failure, Chronic;Cancer, Date of authorisation: 27/08/2007, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR): Binocrit, epoetin alfa, Anemia;Kidney Failure, Chronic, Date of authorisation: 28/08/2007, Revision: 22, Status: Authorised

Parallel distribution: Regulatory and procedural guidance

List of centrally authorised products requiring a notification of a change for update of annexes

Human medicines European public assessment report (EPAR): Prometax, rivastigmine, Alzheimer Disease;Parkinson Disease;Dementia, Date of authorisation: 03/12/1998, Revision: 46, Status: Authorised

Human medicines European public assessment report (EPAR): Fetcroja, cefiderocol, Gram-Negative Bacterial Infections, Date of authorisation: 23/04/2020, Revision: 7, Status: Authorised