MHRA-100398-PIP01-21

Key Facts

Active Substance
Active Substance:
  • ralmitaront
Invented Name
Not yet available
PIP Number MHRA-100398-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Psychiatry
Conditions / Indications
Conditions / Indications:
  • Treatment of schizophrenia
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • Roche Products Limited
  • Country United Kingdom
  • Tel 01707366000
  • Email uk.dra@roche.com
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ralmitaront.pdf
Published Date 07/12/2022