EMEA-003611-PIP01-24 - paediatric investigation plan

diclofenac (sodium)

thiocolchicoside

Key facts

• Active substance:
  • diclofenac (sodium)
  • thiocolchicoside
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  P/0251/2024
• PIP number:
  EMEA-003611-PIP01-24
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of musculoskeletal and connective tissue pain and discomfort
• Route(s) of administration:
  Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/07/2024
• Compliance check done:
  No

Decision

P/0251/2024: EMA decision of 19 July 2024 on the granting of a product specific waiver for diclofenac (sodium) / thiocolchicoside (EMEA-003611- PIP01-24)

Adopted Reference Number: EMA/296527/2024