EMEA-002626-PIP01-19 - paediatric investigation plan

loxoprofen (sodium hydrate)

Key facts

• Active substance:
  loxoprofen (sodium hydrate)
• Therapeutic area:
  Pain
• Decision number:
  P/0417/2019
• PIP number:
  EMEA-002626-PIP01-19
• Pharmaceutical form(s):
  Medicated plaster
• Condition(s) / indication(s):
  Treatment of pain
• Route(s) of administration:
  Topical use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/12/2019
• Compliance check done:
  No

Decision

P/0417/2019: EMA decision of 4 December 2019 on the granting of a product specific waiver for loxoprofen (sodium hydrate) (EMEA-002626-PIP01-19)

Adopted Reference Number: EMA/606267/2019