MHRA-101107-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • BIRCH BARK EXTRACT
Invented Name
  • Filsuvez
  • Filsuvez gel
PIP Number MHRA-101107-PIP01-23-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Gel
Therapeutic area
Therapeutic area:
  • Dermatology
Conditions / Indications
Conditions / Indications:
  • Treatment of epidermolysis bullosa
Route(s) of administration
Route(s) of administration:
  • Cutaneous 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
21/05/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-101107-PIP01-23-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BIRCH BARK EXTRACT.pdf
Published Date 24/06/2024