EMEA-001323-PIP01-12 - paediatric investigation plan

Elagolix

Key facts

• Active Substance:
  Elagolix
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0296/2012
• PIP number:
  EMEA-001323-PIP01-12
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of uterine leiomyoma
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  AbbVie Ltd

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  18/12/2012

Decision

P/0296/2012: EMA decision of 18 December 2012 on the granting of a product-specific waiver for elagolix (EMEA-001323-PIP01-12)

AdoptedReference Number: EMA/802225/2012