EMEA-001361-PIP01-12 - paediatric investigation plan

ketoprofen

omeprazole

Key facts

• Active substance:
  • ketoprofen
  • omeprazole
• Therapeutic area:
  Pain
• Decision number:
  P/0148/2013
• PIP number:
  EMEA-001361-PIP01-12
• Pharmaceutical form(s):
  • Capsule, hard
  • Modified release capsule
• Condition(s) / indication(s):
  Treatment of pain
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/07/2013
• Compliance check done:
  No

Decision

P/0148/2013: EMA decision of 3 July 2013 on the granting of a product-specific waiver for ketoprofen / omeprazole (EMEA-001361-PIP01-12)

Adopted Reference Number: EMA/316683/2013