EMEA-000826-PIP01-09 - paediatric investigation plan

phentermine

Topiramate

Key facts

• Active Substance:
  • phentermine
  • Topiramate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/223/2010
• PIP number:
  EMEA-000826-PIP01-09
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of obesity
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/10/2010

Decision

P/223/2010: European Medicines Agency decision of 29 October 2010 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for phentermine / topiramate, (EMEA-000...

AdoptedReference Number: EMA/654862/2010