EMEA-002017-PIP01-16 - paediatric investigation plan

Ibuprofen

Key facts

• Active substance:
  Ibuprofen
• Therapeutic area:
  Other
• Decision number:
  P/0366/2016
• PIP number:
  EMEA-002017-PIP01-16
• Pharmaceutical form(s):
  Prolonged-release tablet
• Condition(s) / indication(s):
  • Treatment of febrile disorders
  • 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:
  20/12/2016
• Compliance check done:
  No

Decision

P/0366/2016: EMA decision of 21 December 2016 on the granting of a product specific waiver for ibuprofen (EMEA-002017-PIP01-16)

Adopted Reference Number: EMA/757985/2016