MHRA-100699-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • DIROXIMEL FUMARATE
Invented Name
  • Vumerity
  • Vumerity
  • Vumerity
PIP Number MHRA-100699-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Gastro-resistant capsule, hard
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of Multiple Sclerosis
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):DIROXIMEL FUMARATE.pdf
Published Date 30/06/2023