Data in regulation: Big data and other sources

EMEA-003523-PIP01-23

Human medicines European public assessment report (EPAR): Bortezomib Accord, bortezomib, Date of authorisation: 20/07/2015, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Slenyto, melatonin, Date of authorisation: 20/09/2018, Revision: 13, Status: Authorised

EMEA-003515-PIP01-23

EMEA-003299-PIP02-22

EMEA-003522-PIP01-23

Opinion/decision on a Paediatric investigation plan (PIP): Sarclisa, Isatuximab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0049/2024

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – February 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 26 February 2025, 10:00 (CET) to 26 February 2025, 12:00 (CET)

Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification