Orphan designation: Interleukin-12, human, recombinant Treatment of cutaneous T-cell lymphoma, 10/11/2024 Positive
Social Media Data for Real World Evidence in Regulatory Decision Making
Procurement
CTIS newsflash - 19 November 2024
Medical devices
Template - Request for advice on the clinical development strategy or clinical data required for the clinical evaluation pursuant to Article 61(2) or Article 106(11) of Regulation (EU) 2017/745 and MDCG 2024-10 on from the Expert Panels
Template - Request for advice on the orphan device status pursuant to Article 61(2) of Regulation (EU) 2017/745 and MDCG 2024-10
Human medicines European public assessment report (EPAR): Jinarc, tolvaptan, Date of authorisation: 27/05/2015, Revision: 22, Status: Authorised
Human medicines European public assessment report (EPAR): Nezglyal, leriglitazone, Date of refusal: 22/07/2024, Status: Refused
Submission of Manufacturers, Manufacturing Business Operations (MBOs) and structured pack size data to Product Management Service (PMS), Online, European Medicines Agency, Amsterdam, the Netherlands, from 25 November 2024, 10:00 (CET) to 25 November 2024, 11:30 (CET)