MHRA-100115-PIP01-21

Key Facts

PIPS 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

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Dersimelagon.pdf
Published Date 27/09/2022