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
• Contact for public enquiries:

  Verisfield Single Member S.A.

  Email: [e-mail]; tel: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  02/12/2022

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)

AdoptedReference Number: EMA/853429/2022