EMEA-003323-PIP01-22 - paediatric investigation plan

tadalafil

Finasteride

Key facts

• Active substance:
  • tadalafil
  • Finasteride
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0120/2023
• PIP number:
  EMEA-003323-PIP01-22
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of benign prostatic hyperplasia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/04/2023
• Compliance check done:
  No

Decision

P/0120/2023 : EMA decision of 13 April 2023 on the granting of a product specific waiver for tadalafil / finasteride (EMEA-003323-PIP01-22)

Reference Number: EMA/144889/2023