MHRA-100175-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • AGOMELATINE
Invented Name
  • Valdoxan
  • Valdoxan
PIP Number MHRA-100175-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Tablet
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Psychiatry
Conditions / Indications
Conditions / Indications:
  • Treatment of major depressive episodes
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-100175-PIP01-21-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):AGOMELATINE.pdf
Published Date 29/07/2022