Clinical development of medicinal products for the treatment and prevention of bipolar disorder
Draft guideline on clinical development of medicinal products for the treatment and prevention of bipolar disorder - Revision 1
Applications for new human medicines under evaluation: September 2024
Herbal medicinal product: Soiae oleum raffinatumArray, D: Draft under discussion
Herbal medicinal product: MasticArray, F: Assessment finalised
Human medicines European public assessment report (EPAR): Savene, dexrazoxane, Date of authorisation: 27/07/2006, Revision: 15, Status: Authorised
Human medicines European public assessment report (EPAR): Ivabradine Accord, ivabradine, Date of authorisation: 22/05/2017, Revision: 7, Status: Authorised
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2024
Human medicines European public assessment report (EPAR): Multaq, dronedarone, Date of authorisation: 25/11/2009, Revision: 20, Status: Authorised
Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine,elasomeran,elasomeran / imelasomeran,elasomeran / davesomeran,andusomeran, Date of authorisation: 06/01/2021, Revision: 48, Status: Authorised