EMEA-002778-PIP01-20-M01 - paediatric investigation plan

Gadoquatrane (BAY 1747846)

Key facts

• Active Substance:
  Gadoquatrane (BAY 1747846)
• Therapeutic area:
  Diagnostic
• Decision number:
  P/0500/2022
• PIP number:
  EMEA-002778-PIP01-20-M01
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Diagnosis by evaluation of any known or suspected clinical condition with contrast enhanced magnetic resonance imaging
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Bayer AG

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2022

Decision

P/0500/2022 : EMA decision of 1 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for gadoquatrane (BAY 1747846) (EMEA-002778-PIP01-20-M01)

AdoptedReference Number: EMA/873552/2022