EMEA-001983-PIP01-16-M01 - paediatric investigation plan

3,6-diamino-2,5-bis{N-[(1R)-1-carboxy-2-hydroxyethyl]carbamoyl}pyrazine (MB-102)

Key facts

• Active Substance:
  3,6-diamino-2,5-bis{N-[(1R)-1-carboxy-2-hydroxyethyl]carbamoyl}pyrazine (MB-102)
• Therapeutic area:
  • Diagnostic
  • Uro-nephrology
• Decision number:
  P/0457/2022
• PIP number:
  EMEA-001983-PIP01-16-M01
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Monitoring of renal function
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  MediBeacon Inc.

  United States; Tel.: [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/10/2022

Decision

P/0457/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for 3,6-diamino-2,5- bis{N-[(1R)-1-carboxy-2-hydroxyethyl]carbamoyl}pyrazine (MB-102) (EMEA-001983-PIP01-16-M01)

AdoptedReference Number: EMA/776038/2022