Drospirenone / ethinylestradiol bethadex clathrate - paediatric investigation plan

drospirenone

ethinylestradiol bethadex clathrate

Key facts

• Invented name:
  Yaz and associated names
• Active substance:
  • drospirenone
  • ethinylestradiol bethadex clathrate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/24/2009
• PIP number:
  Drospirenone / ethinylestradiol bethadex clathrate
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Contraception
  • Treatment of acne
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  23/02/2009
• Compliance check done:
  Nej

Decision

P/24/2009: European Medicines Agency decision of 23 February 2009 on the refusal of a Paediatric Investigation Plan and on the granting of a waiver for drospirenone / ethinylestradiol bethadex clathrate, Yaz and associat...

Adopted Reference Number: EMEA/95882/2009