Grumpy-XL schreef op 12 maart 2024 07:22:
Update EMA
www.ema.europa.eu/en/documents/minute...Leniolisib - Orphan - EMEA/H/C/005927
Pharming Technologies B.V.; Treatment of activated phosphoinositide 3-kinase delta
Committee for medicinal products for human use (CHMP)
EMA/CHMP/57124/2024
Page 8/52
syndrome (APDS)
Scope: Possible oral explanation
Action: Possible oral explanation to be held on 24 January 2024 at 16:00
List of Outstanding Issues adopted on 09.11.2023, 20.07.2023. List of Questions adopted on 24.01.2023.
The CHMP confirmed that an oral explanation was not needed at this time. See 3.2
…
3.2.2. Leniolisib - Orphan - EMEA/H/C/005927
Pharming Technologies B.V.; Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)
Committee for medicinal products for human use (CHMP)
EMA/CHMP/57124/2024 Page 13/52
Scope: List of outstanding issues Action: For adoption
List of Outstanding Issues adopted on 09.11.2023, 20.07.2023. List of Questions adopted on 24.01.2023.
See 2.1
The Committee was reminded of the status of this application and its remaining outstanding issues.
The CHMP confirmed that an oral explanation was not needed at this time.
The Committee adopted a 3rd list of outstanding issues with a specific timetable.