EMEA-003292-PIP02-22 - paediatric investigation plan

diclofenac (sodium)

pyridoxine (hydrochloride)

cyanocobalamin

Key facts

• Active substance:
  • diclofenac (sodium)
  • pyridoxine (hydrochloride)
  • cyanocobalamin
• Therapeutic area:
  Pain
• Decision number:
  P/0035/2023
• PIP number:
  EMEA-003292-PIP02-22
• Pharmaceutical form(s):
  Treatment of familial Mediterranean fever
• Condition(s) / indication(s):
  • Treatment of inflammatory pain
  • Treatment of inflammatory rheumatic diseases
• Route(s) of administration:
  Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2023
• Compliance check done:
  No

Decision

P/0035/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for diclofenac (sodium) / thiamine (hydrochloride) / pyridoxine (hydrochloride) / cyanocobalamin (EMEA-003292-PIP02-22)

Adopted Reference Number: EMA/21199/2023