EMEA-001163-PIP01-11 - paediatric investigation plan

Clopidogrel (bisulfate)

Acetylsalicylic acid

Key facts

• Active Substance:
  • Clopidogrel (bisulfate)
  • Acetylsalicylic acid
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/270/2011
• PIP number:
  EMEA-001163-PIP01-11
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Prevention of cardiovascular disease
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  TEVA Pharma B.V.

  Croatia; [e-mail] ; [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/10/2011

Decision

P/270/2011: EMA decision of 28 October 2011 on the granting of a product specific waiver for clopidogrel (bisulphate) / acetylsalicylic acid (EMEA- 001163-PIP01-11)

AdoptedReference Number: EMA/849727/2011