P/0321/2014 - paediatric investigation plan

Urofollitropin

Key facts

• Active Substance:
  Urofollitropin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0321/2014
• PIP number:
  P/0321/2014
• Condition(s) / indication(s):
  • Treatment of hypogonadotrophic hypogonadism
  • Treatment of female infertility
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Regiomedica GmbH

  Germany ; E-mail: [e-mail] ; Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/12/2014

Decision

P/0321/2014: EMA decision of 19 December 2014 on the granting of a product specific waiver for urofollitropin (EMEA-001655-PIP01-14)

AdoptedReference Number: EMA/755898/2014