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
• Contact for public enquiries:

  Alfred E. Tiefenbacher (GmbH & Co. KG)

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/09/2021

Decision

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

AdoptedReference Number: EMA/464761/2021