MHRA-101385-PIP01-24

Key Facts

PIPS 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

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Valemetostat tosilate.pdf
Published Date 15/08/2024