Key facts

Active Substance
  • drospirenone
  • L-5-methyltetrahydrofolic acid, calcium salt
  • ethinylestradiol
  • betadex clathrate
Therapeutic area
Decision number
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

Country: Germany
Phone: +49 3046815333
Fax: +49 3046895333

Decision type
W: decision granting a waiver in all age groups for all conditions or indications
Decision date


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