MHRA-101385-PIP01-24

Key Facts

Active Substance
Active Substance:
  • Valemetostat tosilate
Invented Name
EZHARMIA
PIP Number MHRA-101385-PIP01-24
Pharmaceutical form(s)
  • Capsule, hard
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of mature T-cell neoplasms
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(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):Valemetostat tosilate.pdf
Published Date 15/08/2024