Dienogest / ethinylestradiol (as betadex clathrate) / L-5-methyltetrahydrofolic acid, calcium salt - paediatric investigation plan

Dienogest

ethinylestradiol (as betadex clathrate)

L-5-methyltetrahydrofolic acid, calcium salt

Key facts

• Active Substance:
  • Dienogest
  • ethinylestradiol (as betadex clathrate)
  • L-5-methyltetrahydrofolic acid, calcium salt
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/121/2009
• PIP number:
  Dienogest / ethinylestradiol (as betadex clathrate) / L-5-methyltetrahydrofolic acid, calcium salt
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Contraception
  • Inappropriate diet and eating habits
  • Treatment of acne vulgaris
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Bayer Schering Pharma AG

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/06/2009

Decision

P/121/2009: European Medicines Agency decision of 15 June 2009 on the refusal of a Paediatric Investigation Plan and on the granting of a waiver for dienogest / ethinylestradiol (as betadex clathrate) / L-5-methyltetrahy...

AdoptedReference Number: EMEA/351771/2009