Non-Clinical and New Approach Methodologies European Specialised Expert Community
Submitted by Anonymous (not verified) on 9 August 2023 - 16:35
Non-Clinical and New Approach Methodologies European Specialised Expert Community
Mandate, objective and rules of procedure for the Non-Clinical and New Approach Methodologies European Specialised Expert Community
Submitted by Anonymous (not verified) on 9 August 2023 - 16:35
Mandate, objective and rules of procedure for the Non-Clinical and New Approach Methodologies European Specialised Expert Community
Revocation of authorisation for sickle cell disease medicine Adakveo
Submitted by Anonymous (not verified) on 9 August 2023 - 14:28
Revocation of authorisation for sickle cell disease medicine Adakveo
Human medicines European public assessment report (EPAR): Lantus, insulin glargine, Diabetes Mellitus, Date of authorisation: 09/06/2000, Revision: 40, Status: Authorised
Submitted by Anonymous (not verified) on 9 August 2023 - 14:22
Human medicines European public assessment report (EPAR): Lantus, insulin glargine, Diabetes Mellitus, Date of authorisation: 09/06/2000, Revision: 40, Status: Authorised
Withdrawn application: Lagevrio, molnupiravir, Date of withdrawal: 21/06/2023, Initial authorisation
Submitted by Anonymous (not verified) on 9 August 2023 - 9:50
Withdrawn application: Lagevrio, molnupiravir, Date of withdrawal: 21/06/2023, Initial authorisation
Methotrexate supply shortage
Submitted by Anonymous (not verified) on 9 August 2023 - 9:22
Methotrexate supply shortage
Informed consent for paediatric clinical trials in Europe 2015
Submitted by Anonymous (not verified) on 9 August 2023 - 8:19
Informed consent for paediatric clinical trials in Europe 2015
List of eligible industry stakeholder organisations
Submitted by Anonymous (not verified) on 8 August 2023 - 16:00
List of eligible industry stakeholder organisations
Human medicines European public assessment report (EPAR): Trecondi, treosulfan, Hematopoietic Stem Cell Transplantation, Date of authorisation: 20/06/2019, Revision: 4, Status: Authorised
Submitted by Anonymous (not verified) on 8 August 2023 - 15:14
Human medicines European public assessment report (EPAR): Trecondi, treosulfan, Hematopoietic Stem Cell Transplantation, Date of authorisation: 20/06/2019, Revision: 4, Status: Authorised
Morphine / cyclizine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010549/202210
Submitted by Anonymous (not verified) on 8 August 2023 - 14:40
Morphine / cyclizine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010549/202210