EMEA-002547-PIP01-19 - paediatric investigation plan

Human chorionic gonadotrophin

Key facts

• Active Substance:
  Human chorionic gonadotrophin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0283/2019
• PIP number:
  EMEA-002547-PIP01-19
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of female infertility
• Route(s) of administration:
  • Intramuscular use
  • Subcutaneous use
• Contact for public enquiries:

  Regulis Consulting Europe Ltd

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/08/2019

Decision

P/0283/2019: EMA decision of 16 August 2019 on the granting of a product specific waiver for human chorionic gonadotrophin, (EMEA-002547-PIP01-19)

AdoptedReference Number: EMA/441032/2019