MHRA-100115-PIP01-21

Key Facts

Active Substance
Active Substance:
  • Dersimelagon
Invented Name
Not available at present
PIP Number MHRA-100115-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film coated tablet, Age-appropriate dosage form
Therapeutic area
Therapeutic area:
  • Dermatology
Conditions / Indications
  • Treatment of erythropoietic protoporphyria
  • Treatment of X-linked protoporphyria
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(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):Dersimelagon.pdf
Published Date 27/09/2022