EMEA-001873-PIP01-15 - paediatric investigation plan

testosterone

Key facts

• Active substance:
  testosterone
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0087/2016
• PIP number:
  EMEA-001873-PIP01-15
• Pharmaceutical form(s):
  Eye drops, solution
• Condition(s) / indication(s):
  Treatment of dry eye disease
• Route(s) of administration:
  Ocular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  18/03/2016
• Compliance check done:
  No

Decision

P/0087/2016: EMA decision of 18 March 2016 on the granting of a product specific waiver for testosterone (EMEA-001873-PIP01-15)

Adopted Reference Number: EMA/136748/2016