Ibuprofen / Famotidine - paediatric investigation plan

Ibuprofen

Famotidine

Key facts

• Active substance:
  • Ibuprofen
  • Famotidine
• Therapeutic area:
  Pain
• Decision number:
  P/201/2009
• PIP number:
  Ibuprofen / Famotidine
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Chronic pain due to arthropathies
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/10/2009
• Compliance check done:
  No

Decision

P/201/2009: European Medicines Agency decision of 9 October 2009 on the granting of a product specific waiver for ibuprofen / famotidine (EMEA-000616-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the Europ...

Adopted Reference Number: EMEA/617482/2009