EMEA-000007-PIP04-12 - paediatric investigation plan

Ezetimibe

Key facts

• Invented name:
  Ezetrol and associated names
• Active Substance:
  Ezetimibe
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0135/2012
• PIP number:
  EMEA-000007-PIP04-12
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Prevention of coronary heart disease
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  20/07/2012

Decision

P/0135/2012: EMA decision of 20 July 2012 on the granting of a product specific waiver for ezetimibe (Ezetrol and associated names) (EMEA- 000007-PIP04-12)

AdoptedReference Number: EMA/452159/2012