Timetable: Initial (Full) marketing authorisation application - ATMP

Timetable: Informed consent and multiple application

Timetable: Extension application

Timetable: Accelerated assessment request for initial marketing authorisations - ATMP

Timetable accelerated assessment request for initial marketing authorisation applications

Orphan designation: vatiquinone Treatment of RARS2 syndrome, 17/01/2018 Withdrawn

Orphan designation: vatiquinone Treatment of Alpers-Huttenlocher syndrome, 10/12/2021 Withdrawn

Orphan designation: vatiquinone Treatment of mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes, 24/02/2022 Withdrawn

Orphan designation: perflubron Treatment of respiratory distress syndrome, 09/12/2020 Withdrawn

Orphan designation: C1 esterase inhibitor (human) Treatment in solid organ transplantation, 14/12/2018 Withdrawn