EMEA-001558-PIP01-13 - paediatric investigation plan

Diclofenac sodium

thiocolchicoside

Key facts

• Invented name:
  Muscoplus
• Active Substance:
  • Diclofenac sodium
  • thiocolchicoside
• Therapeutic area:
  Pain
• Decision number:
  P/0056/2014
• PIP number:
  EMEA-001558-PIP01-13
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of musculoskeletal and connective tissue pain
• Route(s) of administration:
  Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/03/2014

Decision

P/0056/2014: European Medicines Agency decision of 7 March 2014 on the granting of a product specific waiver for diclofenac sodium / thiocolchicoside (EMEA-001558-PIP01-13)

AdoptedReference Number: EMA/53679/2014