Estradiol valerate / Dienogest - paediatric investigation plan

Estradiol valerate

Dienogest

Key facts

• Invented name:
  Qlaira
• Active substance:
  • Estradiol valerate
  • Dienogest
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/140/2009
• PIP number:
  Estradiol valerate / Dienogest
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Excessive, frequent and irregular menstruation
  • Contraception
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/07/2009
• Compliance check done:
  No

Decision

P/140/2009: European Medicines Agency decision of 15 July 2009 on the refusal of a Paediatric Investigation Plan and on the refusal of a deferral and on the granting of a waiver for estradiol valerate / dienogest (Qlaira...

Adopted Reference Number: EMEA/387209/2009