EMEA-000085-PIP01-07 - paediatric investigation plan

Flibanserin

Key facts

• Active substance:
  Flibanserin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/20/2008
• PIP number:
  EMEA-000085-PIP01-07
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Hypoactive Sexual Desire Disorder in Women
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/04/2008
• Compliance check done:
  Ne

Decision

P/20/2008: European medicines agency decision of 28 April 2008 on the application for product specific waiver for flibanserin, EMEA-000085-PIP01-07 in accordance with Regulation (EC) No 1901/2006 of the European Parliam...

Adopted Reference Number: EMEA/212132/2008