Drospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic acid, calcium salt - paediatric investigation plan

drospirenone

L-5-methyltetrahydrofolic acid, calcium salt

ethinylestradiol

betadex clathrate

Key facts

• Active Substance:
  • drospirenone
  • L-5-methyltetrahydrofolic acid, calcium salt
  • ethinylestradiol
  • betadex clathrate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/89/09
• PIP number:
  Drospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic acid, calcium salt
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Contraception
  • Inappropriate diet and eating habits
• 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:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  18/05/2009

Decision

P/89/09: European medicines agency decision of 18 May 2009 on the refusal of a Paediatric Investigation Plan and on the granting of a waiver for drospirenone / ethinylestradiol, betadex clathrate / L-5 methyltetrahydrofo...

AdoptedReference Number: EMEA/272661/2009