EMEA-001026-PIP01-10 - paediatric investigation plan

testosterone

Key facts

• Active substance:
  testosterone
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/60/2011
• PIP number:
  EMEA-001026-PIP01-10
• Pharmaceutical form(s):
  Cutaneous solution
• Condition(s) / indication(s):
  Treatment of male hypogonadism
• Route(s) of administration:
  Cutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/03/2011
• Compliance check done:
  No

Decision

P/60/2011: EMA decision of 4 March 2011 on the granting of a product specific waiver for testosterone (EMEA-001026-PIP01-10) in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council

Adopted Reference Number: EMA/78568/2011