MHRA-100787-PIP01-22

Key Facts

Active Substance
Active Substance:
  • Repotrectinib
Invented Name
Not available at present
PIP Number MHRA-100787-PIP01-22
Pharmaceutical form(s)
  • Capsule, hard
  • Oral suspension
Therapeutic area
  • Oncology
  • Other: Not Applicable
Conditions / Indications
Conditions / Indications:
  • Treatment of all conditions included in the category of malignant neoplasm (except haematopoietic neoplasms)
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
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-100787-PIP01-22-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Repotrectinib.pdf
Published Date 19/12/2023