EMEA-001529-PIP02-14-M03 - paediatric investigation plan

testosterone

Key facts

• Active substance:
  testosterone
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0508/2020
• PIP number:
  EMEA-001529-PIP02-14-M03
• Pharmaceutical form(s):
  Nasal gel
• Condition(s) / indication(s):
  Treatment of male hypogonadism
• Route(s) of administration:
  Nasal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  22/12/2020
• Compliance check done:
  No

Decision

P/0508/2020: EMA decision of 22 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for testosterone (EMEA-001529-PIP02-14-M03)

Adopted Reference Number: EMA/633001/2020