Human medicines European public assessment report (EPAR): Rapiscan, regadenoson, Date of authorisation: 06/09/2010, Revision: 17, Status: Authorised
EMA/PE/0000181518
EMA/PE/0000181441
EMA/PE/0000221101
Opinion/decision on a Paediatric investigation plan (PIP): Trixeo Aerosphere, Budesonide,Formoterol (fumarate),glycopyrronium bromide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Respiratory, thoracic and mediastinal disorders, PIP number: EMA/PE/0000181335
EMA/PE/0000220986
Human medicines European public assessment report (EPAR): Datroway, datopotamab deruxtecan, Date of authorisation: 04/04/2025, Revision: 3, Status: Authorised
Agenda - Management Board meeting: 17-18 December 2025
Meeting on the impact of chemical and environmental policies on the healthcare sector and availability of medicines, European Medicines Agency, Amsterdam, the Netherlands, 19 December 2025
Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group