EMEA-000250-PIP01-08-M02 - paediatric investigation plan

Nomegestrol acetate

17 beta-estradiol

Key facts

• Active Substance:
  • Nomegestrol acetate
  • 17 beta-estradiol
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/61/2010
• PIP number:
  EMEA-000250-PIP01-08-M02
• Pharmaceutical form(s):
  Film-coated 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:
  09/03/2010
• Compliance procedure number:
  EMEA-C-000250-PIP01-08-M02
• Compliance opinion date:
  21/05/2010
• Compliance outcome:
  Positive

Decision

P/61/2010: European Medicines Agency decision on the acceptance of a modification of an agreed paediatric investigation plan for nomegestrol acetate / 17 beta - estradiol (EMEA-000250-PIP01-08-M02)

AdoptedReference Number: EMA/216040/2010