EMEA-002102-PIP01-16 - paediatric investigation plan

Ibuprofen

pseudoephedrine

Key facts

• Active substance:
  • Ibuprofen
  • pseudoephedrine
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0159/2017
• PIP number:
  EMEA-002102-PIP01-16
• Pharmaceutical form(s):
  Oral suspension
• Condition(s) / indication(s):
  • Treatment of nasal congestion and inflammations
  • 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:
  30/06/2017
• Compliance check done:
  No

Decision

P/0159/2017: EMA decision of 30 June 2017 on the granting of a product specific waiver for ibuprofen / pseudoephedrine (EMEA-002102-PIP01-16)

Adopted Reference Number: EMA/398292/2017