EMEA-000829-PIP01-09 - paediatric investigation plan

levonorgestrel

ethinylestradiol

Key facts

• Active substance:
  • levonorgestrel
  • ethinylestradiol
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/135/2010
• PIP number:
  EMEA-000829-PIP01-09
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Contraception
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/07/2010
• Compliance check done:
  No

Decision

P/135/2010: European Medicines Agency decision of 28 July 2010 on the granting of a product specific waiver for levonorgestrel/ethinylestradiol (EMEA-000829-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of t...

Adopted Reference Number: EMA/463871/2010