EMEA-000049-PIP01-07-M03 - paediatric investigation plan

clopidogrel

Key facts

• Invented name:
  • Plavix
  • Plavix
• Active substance:
  clopidogrel
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/233/2010
• PIP number:
  EMEA-000049-PIP01-07-M03
• Pharmaceutical form(s):
  • Oral formulation
  • Film-coated tablet
• Condition(s) / indication(s):
  Prevention of thromboembolic events
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  26/11/2010
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000049-PIP01-07-M03
• Compliance opinion date:
  10/12/2010
• Compliance outcome:
  Positive

Decision

P/233/2010: EMA decision of 26 November 2010 on the acceptance of a modification of an agreed paediatric investigation plan for clopidogrel (Plavix) (EMEA-000049-PIP01-07-M03)

Adopted Reference Number: EMA/706562/2010