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/90/2009
• 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
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  18/05/2009
• Compliance check done:
  No

Decision

P/90/2009: 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 methyltetrahydro...

Adopted Reference Number: EMEA/272662/2009