Clopidogrel - paediatric investigation plan

clopidogrel

Key facts

• Invented name:
  • Clopidogrel Winthrop
  • Clopidogrel Zentiva (previously Clopidogrel Winthrop)
• Active substance:
  clopidogrel
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/189/2009
• PIP number:
  Clopidogrel
• Pharmaceutical form(s):
  • Age appropriate oral formulation
  • Film-coated tablet
• Condition(s) / indication(s):
  Thromboembolic events
• 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:
  22/09/2009
• Compliance check done:
  No

Decision

P/189/2009: European Medicines Agency decision of 22 September 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for clopidogrel (Clopidogrel Winth...

Adopted Reference Number: EMEA/PDCO/583267