EMEA-001473-PIP01-13 - paediatric investigation plan

Acetylsalicylic acid

omeprazole

Key facts

• Active Substance:
  • Acetylsalicylic acid
  • omeprazole
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0316/2013
• PIP number:
  EMEA-001473-PIP01-13
• Pharmaceutical form(s):
  Modified-release film-coated tablet
• Condition(s) / indication(s):
  • Prevention of cerebrovascular embolism and thrombosis
  • Prevention of ischaemic coronary artery disorders
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Pozen UK

  Limited United Kingdom ; E-mail: [e-mail] ; Tel. [phone] ; Fax [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/12/2013

Decision

P/0316/2013: EMA decision of 19 December 2013 on the granting of a product specific waiver for acetylsalicylic acid / omeprazole (EMEA-001473-PIP01-13)

AdoptedReference Number: EMA/693817/2013