EMEA-001652-PIP01-14-M05 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: P/0162/2023
Route(s) of administration: Oral use
Pharmaceutical form(s):
Capsule (hard)
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Daxas
roflumilast
Pulmonary Disease, Chronic Obstructive
Date of authorisation:
Revision: 21
Last updated:
MedicineHumanAuthorised
Libertek
roflumilast
Pulmonary Disease, Chronic Obstructive
Date of authorisation:
Revision: 11
Last updated:
MedicineHumanWithdrawn
Daliresp
roflumilast
Pulmonary Disease, Chronic Obstructive
Date of authorisation:
Revision: 9
Last updated:
MedicineHumanWithdrawn
Roflumilast - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pneumology-allergology
PIP number: P/21/2008
Route(s) of administration: Oral use
Pharmaceutical form(s):
Tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman