MHRA-100069-PIP01-21

Key Facts

Active Substance
Active Substance:
  • RIBOCICLIB
Invented Name
  • KISQALI
  • KISQALI
PIP Number MHRA-100069-PIP01-21
Pharmaceutical form(s)
  • Film coated tablet
  • Age-appropriate oral liquid dosage form
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of neuroblastoma
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
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):RIBOCICLIB.pdf
Published Date 02/11/2022