Ulipristal acetate - paediatric investigation plan

ulipristal acetate

Key facts

• Active Substance:
  ulipristal acetate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/215/2009
• PIP number:
  Ulipristal acetate
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Leiomyoma of uterus
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  PregLem SA

  E-mail: [e-mail]; Country: Switzerland; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/10/2009

Decision

P/215/2009: European Medicines Agency decision of 30 October 2009 on the refusal of a Paediatric Investigation Plan and on the refusal of a deferral and on the granting of a waiver for ulipristal acetate (EMEA-000629-PIP...

AdoptedReference Number: EMEA/687582/2009