MHRA-100232-PIP01-21

Key Facts

Active Substance
Active Substance:
  • ALECTINIB
Invented Name
  • Alecensa
  • Alecensa
PIP Number MHRA-100232-PIP01-21
Pharmaceutical form(s)
  • Capsule, hard
  • Age appropriate oral liquid dosage form
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • Roche Products Limited
  • Country United Kingdom
  • Tel 01707368600
  • 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):ALECTINIB.pdf
Published Date 17/05/2022