Opinions and letters of support on the qualification of novel methodologies for medicine development

Overview of comments received on the draft qualification opinion for Simcyp Simulator

Qualification opinion for Simcyp Simulator

Human medicines European public assessment report (EPAR): Saxenda, liraglutide, Date of authorisation: 23/03/2015, Revision: 19, Status: Authorised

List of EU Medicines Regulatory Agency Organisation with single and multiple LOC IDs for Product Management Services (PMS) data enrichment - Chapter 2 Annex III

PSUSA/00000832/202411

Human medicines European public assessment report (EPAR): Trulicity, dulaglutide, Date of authorisation: 21/11/2014, Revision: 20, Status: Authorised

Human medicines European public assessment report (EPAR): Delstrigo, doravirine,lamivudine,tenofovir disoproxil, Date of authorisation: 22/11/2018, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Xofluza, baloxavir marboxil, Date of authorisation: 07/01/2021, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Reagila, cariprazine, Date of authorisation: 13/07/2017, Revision: 11, Status: Authorised