EMEA-003294-PIP01-22 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: P/0534/2022
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Solution for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Arikayce liposomal
amikacin
Respiratory Tract Infections
Date of authorisation:
Revision: 2
Last updated:
MedicineHumanAuthorised
EMEA-000525-PIP01-08-M08 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: P/0107/2022
Route(s) of administration: Inhalation use
Pharmaceutical form(s):
Nebuliser dispersion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Arikayce
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application