EMEA-003339-PIP02-23 - paediatric investigation plan

diclofenac

thiocolchicoside

Key facts

• Active Substance:
  • diclofenac
  • thiocolchicoside
• Therapeutic area:
  Pain
• Decision number:
  P/0161/2023
• PIP number:
  EMEA-003339-PIP02-23
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of pain
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Verisfield Single Member S.A.

  Email: [e-mail]

  [e-mail] ; tel: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/05/2023

Decision

P/0161/2023 : EMA decision of 12 May 2023 on the granting of a product specific waiver for diclofenac / thiocolchicoside (EMEA-003339-PIP02-23)

AdoptedReference Number: EMA/170255/2023