MHRA-100166-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • ENTRECTINIB
Invented Name
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
PIP Number MHRA-100166-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Capsule, hard
  • Coated granules
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).
Route(s) of administration
  • Oral use
  • Gastric use
PIP applicant
  • Roche Products Limited
  • Country United Kingdom
  • Tel 01707366000
  • Email uk.dra@roche.com
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 opinion date
27/04/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100166-PIP01-21-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ENTRECTINIB.pdf
Published Date 14/04/2026