EMA/PE/0000183373 - paediatric investigation plan

tadalafil

tamsulosin

Key facts

• Active substance:
  • tadalafil
  • tamsulosin
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  EMA/PE/0000183373
• PIP number:
  EMA/PE/0000183373
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of 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:
  06/12/2024
• Compliance check done:
  Nem

Decision

EMA/PE/0000183373 : EMA decision of 6 December 2024 on the granting of a product specific waiver for tadalafil, tamsulosin

Adopted Reference Number: EMADOC-1700519818-1775261