EMEA-002754-PIP01-19 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Uro-nephrology
PIP number: P/0017/2021
Route(s) of administration: Oral use
Pharmaceutical form(s):
Capsule (hard)
Age appropriate oral formulation
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Turalio
Pexidartinib
Giant Cell Tumor of Tendon Sheath
Synovitis, Pigmented Villonodular
Date of refusal:
Last updated:
MedicineHumanRefused
Duzallo
allopurinol
lesinurad
Gout
Date of authorisation:
Revision: 2
Last updated:
MedicineHumanWithdrawn
EMEA-001939-PIP03-16 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: P/0044/2019
Route(s) of administration: Oral use
Pharmaceutical form(s):
Capsule (hard)
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001952-PIP01-16 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0239/2016
Route(s) of administration: Oral use
Pharmaceutical form(s):
Tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman