List of medicines currently in PRIME scheme
Submitted by Anonymous (not verified) on 1 August 2024 - 16:40
List of medicines currently in PRIME scheme
Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 22-25 July 2024
Submitted by Anonymous (not verified) on 1 August 2024 - 16:39
Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 22-25 July 2024
Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 June 2024, 13:00 (CEST) to 19 June 2024, 18:00 (CEST)
Submitted by Anonymous (not verified) on 1 August 2024 - 16:10
Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 June 2024, 13:00 (CEST) to 19 June 2024, 18:00 (CEST)
Human medicines European public assessment report (EPAR): Durveqtix, fidanacogene elaparvovec, Date of authorisation: 24/07/2024, Status: Authorised
Submitted by Anonymous (not verified) on 1 August 2024 - 12:40
Human medicines European public assessment report (EPAR): Durveqtix, fidanacogene elaparvovec, Date of authorisation: 24/07/2024, Status: Authorised
Orphan designation: Recombinant human ADAMTS-13 Treatment of thrombotic thrombocytopenic purpura, 03/12/2008 Positive
Submitted by Anonymous (not verified) on 1 August 2024 - 12:00
Orphan designation: Recombinant human ADAMTS-13 Treatment of thrombotic thrombocytopenic purpura, 03/12/2008 Positive
Real-world evidence
Submitted by Anonymous (not verified) on 1 August 2024 - 10:11
Real-world evidence
Infosheet: EMA review of real-world data studies
Submitted by Anonymous (not verified) on 1 August 2024 - 10:10
Infosheet: EMA review of real-world data studies
Real-world evidence framework to support EU regulatory decision-making: 2nd report on the experience gained with regulator-led studies from February 2023 to February 2024
Submitted by Anonymous (not verified) on 1 August 2024 - 9:55
Real-world evidence framework to support EU regulatory decision-making: 2nd report on the experience gained with regulator-led studies from February 2023 to February 2024
Antimicrobial Sales and Use (ASU) Platform: Release notes
Submitted by Anonymous (not verified) on 1 August 2024 - 8:54
Antimicrobial Sales and Use (ASU) Platform: Release notes
Surgiflo haemostatic matrix kit - Ferrosan - Procedural steps and scientific information after initial consultation
Submitted by Anonymous (not verified) on 30 July 2024 - 15:20
Surgiflo haemostatic matrix kit - Ferrosan - Procedural steps and scientific information after initial consultation