EMEA-003261-PIP01-22 - paediatric investigation plan

Finasteride

tadalafil

Key facts

• Active substance:
  • Finasteride
  • tadalafil
• Therapeutic area:
  Other
• Decision number:
  P/0461/2022
• PIP number:
  EMEA-003261-PIP01-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of patients with benign prostatic hyperplasia
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/10/2022
• Compliance check done:
  No

Decision

P/0461/2022 : EMA decision of 28 October 2022 on the granting of a product specific waiver for finasteride / tadalafil (EMEA-003261-PIP01-22)

Adopted Reference Number: EMA/790520/2022