Tibsovo
ivosidenib
Leukemia, Myeloid, Acute
Cholangiocarcinoma
Date of authorisation:
Revision: 1
Last updated:
MedicineHumanAuthorised
Tidhesco
ivosidenib
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application
Tibsovo
ivosidenib
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application
EMEA-002247-PIP02-17 - paediatric investigation plan
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Oncology
PIP number: P/0406/2019
Route(s) of administration: Oral useNaso-gastric use
Pharmaceutical form(s):
Film-coated tablet
Age-appropriate oral solid dosage form
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-002247-PIP03-17 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: P/0280/2018
Route(s) of administration: Oral useNaso-gastric use
Pharmaceutical form(s):
Film-coated tablet
Age-appropriate oral solid dosage form
Decision date:
Last updated:
Compliance check: ✖
PIPHuman