EMEA-002580-PIP01-19 - paediatric investigation plan

Diclofenac (sodium)

thiocolchicoside

Key facts

• Active Substance:
  • Diclofenac (sodium)
  • thiocolchicoside
• Therapeutic area:
  Pain
• Decision number:
  P/0397/2019
• PIP number:
  EMEA-002580-PIP01-19
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of pain
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  Win Medica S.A.

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/12/2019

Decision

P/0397/2019: EMA decision of 4 December 2019 on the granting of a product specific waiver for diclofenac (sodium) / thiocolchicoside (EMEA-002580-PIP01-19)

AdoptedReference Number: EMA/606270/2019