EMEA-003004-PIP01-21 - paediatric investigation plan

prednisolone

Key facts

• Active substance:
  prednisolone
• Therapeutic area:
  Oncology
• Decision number:
  P/0376/2021
• PIP number:
  EMEA-003004-PIP01-21
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of prostate malignant neoplasms
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/09/2021
• Compliance check done:
  No

Decision

P/0376/2021 : EMA decision of 8 September 2021 on the granting of a product specific waiver for prednisolone (EMEA-003004-PIP01-21)

Adopted Reference Number: EMA/464761/2021