MHRA-100087-PIP01-21-M03 (update)

Key Facts

Active Substance
Active Substance:
  • LACOSAMIDE
Invented Name
VIMPAT
PIP Number MHRA-100087-PIP01-21-M03 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Syrup
  • Solution for infusion
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of generalised epilepsy and epileptic syndromes.
Route(s) of administration
  • Oral use
  • INTRAVENOUS USE
PIP applicant
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
29/04/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-100087-PIP01-21-M03-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):LACOSAMIDE.pdf
Published Date 23/07/2026