EMEA-003292-PIP01-22 - paediatric investigation plan

cyanocobalamin

diclofenac (potassium)

pyridoxine (hydrochloride)

thiamine hydrochloride

Key facts

• Active substance:
  • cyanocobalamin
  • diclofenac (potassium)
  • pyridoxine (hydrochloride)
  • thiamine hydrochloride
• Therapeutic area:
  • Immunology-Rheumatology-Transplantation
  • Pain
• Decision number:
  P/0499/2022
• PIP number:
  EMEA-003292-PIP01-22
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Treatment of inflammatory pain
  • Treatment of inflammatory rheumatic diseases
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  02/12/2022
• Compliance check done:
  No

Decision

P/0499/2022 : EMA decision of 2 December 2022 on the granting of a product specific waiver for diclofenac (potassium) / thiamine (hydrochloride) / pyridoxine (hydrochloride) / cyanocobalamin (EMEA-003292-PIP01-22)

Adopted Reference Number: EMA/853429/2022