EMEA-002850-PIP02-21 - paediatric investigation plan

Dersimelagon

Key facts

• Active Substance:
  Dersimelagon
• Therapeutic area:
  Dermatology
• Decision number:
  P/0216/2022
• PIP number:
  EMEA-002850-PIP02-21
• Pharmaceutical form(s):
  • Age-appropriate dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  • Treatment of erythropoietic protoporphyria
  • Treatment of X-linked protoporphyria
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Mitsubishi Tanabe Pharma GmbH

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  10/06/2022

Decision

P/0216/2022: EMA decision of 10 June 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dersimelagon (EMEA-002850-PIP02-21)

AdoptedReference Number: EMA/366139/2022