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What's new

What's new

EU/HMA Big Data Stakeholder Forum 2022, from 01/12/2022 to 01/12/2022

EU/HMA Big Data Stakeholder Forum 2022, from 01/12/2022 to 01/12/2022

25 November 2022

Human medicines European public assessment report (EPAR): Remsima, infliximab, Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis, Ulcerative;Psoriasis;Crohn Disease;Arthritis, Rheumatoid, Date of authorisation: 10/09/2013, Revision: 30, Status: Authorised

Human medicines European public assessment report (EPAR): Remsima, infliximab, Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis, Ulcerative;Psoriasis;Crohn Disease;Arthritis, Rheumatoid, Date of authorisation: 10/09/2013, Revision: 30, Status: Authorised

25 November 2022

Human medicines European public assessment report (EPAR): Revlimid, lenalidomide, Multiple Myeloma;Lymphoma, Mantle-Cell;Myelodysplastic Syndromes, Date of authorisation: 14/06/2007, Revision: 47, Status: Authorised

Human medicines European public assessment report (EPAR): Revlimid, lenalidomide, Multiple Myeloma;Lymphoma, Mantle-Cell;Myelodysplastic Syndromes, Date of authorisation: 14/06/2007, Revision: 47, Status: Authorised

25 November 2022

Human medicines European public assessment report (EPAR): Rubraca, rucaparib, Ovarian Neoplasms, Date of authorisation: 23/05/2018, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR): Rubraca, rucaparib, Ovarian Neoplasms, Date of authorisation: 23/05/2018, Revision: 10, Status: Authorised

25 November 2022

Human medicines European public assessment report (EPAR): Multaq, dronedarone, Atrial Fibrillation, Date of authorisation: 25/11/2009, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR): Multaq, dronedarone, Atrial Fibrillation, Date of authorisation: 25/11/2009, Revision: 18, Status: Authorised

25 November 2022

Human medicines European public assessment report (EPAR): Comirnaty, tozinameran,riltozinameran and tozinameran,famtozinameran and tozinameran,COVID-19 mRNA Vaccine (nucleoside modified), COVID-19 virus infection, Date of authorisation: 21/12/2020, Revision: 34, Status: Authorised

Human medicines European public assessment report (EPAR): Comirnaty, tozinameran,riltozinameran and tozinameran,famtozinameran and tozinameran,COVID-19 mRNA Vaccine (nucleoside modified), COVID-19 virus infection, Date of authorisation: 21/12/2020, Revision: 34, Status: Authorised

25 November 2022

Human medicines European public assessment report (EPAR): Tasmar, tolcapone, Parkinson Disease, Date of authorisation: 27/08/1997, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR): Tasmar, tolcapone, Parkinson Disease, Date of authorisation: 27/08/1997, Revision: 24, Status: Authorised

25 November 2022

Human medicines European public assessment report (EPAR): Tavneos, avacopan, Microscopic Polyangiitis;Wegener Granulomatosis, Date of authorisation: 11/01/2022, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Tavneos, avacopan, Microscopic Polyangiitis;Wegener Granulomatosis, Date of authorisation: 11/01/2022, Revision: 1, Status: Authorised

25 November 2022

Human medicines European public assessment report (EPAR): Melatonin Neurim, melatonin, Sleep Initiation and Maintenance Disorders, Date of authorisation: 07/11/2022, Status: Authorised

Human medicines European public assessment report (EPAR): Melatonin Neurim, melatonin, Sleep Initiation and Maintenance Disorders, Date of authorisation: 07/11/2022, Status: Authorised

25 November 2022

Dorzolamide : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003168/202202

Dorzolamide : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003168/202202

25 November 2022