Dienogest - paediatric investigation plan

Dienogest

Key facts

• Active Substance:
  Dienogest
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/98/2008
• PIP number:
  Dienogest
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of endometriosis
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  03/11/2008

Decision

P/98/2008: European Medicines Agency decision of 3 November 2008 on the application for agreement of a Paediatric Investigation Plan for dienogest (EMEA-000147-PIP01-07) in accordance with Regulation (EC) No 1901/2006 of...

AdoptedReference Number: EMEA/572815/2008