EMEA-000305-PIP01-08-M02 - paediatric investigation plan

ulipristal acetate

Key facts

• Invented name:
  • ellaOne
  • ellaOne
• Active substance:
  ulipristal acetate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/198/2011
• PIP number:
  EMEA-000305-PIP01-08-M02
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Contraception
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/08/2011
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-000305-PIP01-08-M02
• Compliance opinion date:
  08/11/2013
• Compliance outcome:
  Positive

Decision

P/198/2011: EMA decision of 30 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ulipristal acetate (EllaOne), (EMEA-000305-PIP01-08-M02)

Adopted Reference Number: EMA/642354/2011