EMEA-002612-PIP02-22 - paediatric investigation plan

2-amino-5-(carbamylamino)pentanoic acid (L-citrulline)

Key facts

• Active Substance:
  2-amino-5-(carbamylamino)pentanoic acid (L-citrulline)
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0151/2023
• PIP number:
  EMEA-002612-PIP02-22
• Pharmaceutical form(s):
  Solution for injection/infusion
• Condition(s) / indication(s):
  Treatment of sickle cell disease
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  ASK Pharmaceuticals GmbH (ASK)

  Email: [e-mail]

  Tel: [phone] ext 113

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  24/04/2024

Decision

P/0151/2023 : EMA decision of 24 April 2023 on the agreement of a paediatric investigation plan and on the granting of a waiver for 2-amino-5- (carbamylamino)pentanoic acid (L-citrulline), (EMEA-002612-PIP02-22)

AdoptedReference Number: EMA/177599/2023