EMEA-003337-PIP01-22 - paediatric investigation plan

diclofenac

orphenadrine (citrate)

Key facts

• Active Substance:
  • diclofenac
  • orphenadrine (citrate)
• Therapeutic area:
  Pain
• Decision number:
  P/0036/2023
• PIP number:
  EMEA-003337-PIP01-22
• Pharmaceutical form(s):
  • Solution for infusion
  • Tablet
• Condition(s) / indication(s):
  Treatment of pain
• Route(s) of administration:
  • Intravenous use
  • 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:
  31/01/2023

Decision

P/0036/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for diclofenac / orphenadrine (citrate) (EMEA-003337- PIP01-22)

AdoptedReference Number: EMA/21196/2023