Testosterone - paediatric investigation plan

testosterone

Key facts

• Active substance:
  testosterone
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/161/2009
• PIP number:
  Testosterone
• Pharmaceutical form(s):
  Transdermal patch
• Condition(s) / indication(s):
  Treatment of hypoactive sexual desire disorder
• Route(s) of administration:
  Transdermal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/08/2009
• Compliance check done:
  Nem

Decision

P/161/2009: European Medicines Agency decision of 11 August 2009 on the granting of a product specific waiver for testosterone (Livensa) (EMEA-000572-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the Europ...

Adopted Reference Number: EMEA/420706/2009