EMA/PE/0000181891 - paediatric investigation plan

sildenafil citrate

testosterone

Key facts

• Active substance:
  • sildenafil citrate
  • testosterone
• Therapeutic area:
  Psychiatric disorders
• Decision number:
  EMA/PE/0000181891
• PIP number:
  EMA/PE/0000181891
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of hypoactive sexual desire disorder
• Route(s) of administration:
  • Sublingual use
  • Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  25/10/2024
• Compliance check done:
  No

Decision

EMA/PE/0000181891: EMA decision of 25 October 2024 on the granting of a product specific waiver for sildenafil citrate, testosterone (EMA/PE/0000181891)

Adopted Reference Number: EMADOC-1700519818-1690068