EMEA-003391-PIP01-23 - paediatric investigation plan

amphotericin B

Key facts

• Active substance:
  amphotericin B
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0199/2023
• PIP number:
  EMEA-003391-PIP01-23
• Pharmaceutical form(s):
  Oral suspension
• Condition(s) / indication(s):
  Treatment of cryptococcosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/06/2023
• Compliance check done:
  No

Decision

P/0199/2023 : EMA decision of 13 June 2023 on the granting of a product specific waiver for amphotericin B (EMEA-003391-PIP01-23)

Reference Number: EMA/241151/2023