EMEA-001181-PIP01-11-M06 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: P/0115/2021
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✔
PIPHuman
Thymanax
Agomelatine
Depressive Disorder, Major
Date of authorisation:
Date of refusal:
Revision: 24
Last updated:
MedicineHumanWithdrawn
Valdoxan
Agomelatine
Depressive Disorder, Major
Date of authorisation:
Revision: 24
Last updated:
MedicineHumanAuthorised
EMEA-002206-PIP02-19 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: P/0366/2020
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Suspension for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Valdoxan
Agomelatine
Depressive Disorder, Major
Date of refusal:
Last updated:
MedicineHumanRefused
Thymanax
Agomelatine
Depressive Disorder, Major
Date of refusal:
Last updated:
MedicineHumanRefused