Ibuprofen, diphenhydramine hydrochloride - paediatric investigation plan

Ibuprofen

diphenhydramine hydrochloride

Key facts

• Active Substance:
  • Ibuprofen
  • diphenhydramine hydrochloride
• Therapeutic area:
  Pain
• Decision number:
  P/118/2008
• PIP number:
  Ibuprofen, diphenhydramine hydrochloride
• Pharmaceutical form(s):
  Capsule (soft)
• Condition(s) / indication(s):
  Mild to moderate pain with sleeplessness
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2008

Decision

P/118/2008: European Medicines Agency decision of 1 December 2008 on the application for product specific waiver ibuprofen, diphenhydramine hydrochloride (EMEA-000220-PIP01-08) in accordance with Regulation (EC) No 1901/...

AdoptedReference Number: EMEA/623766/2008