EMEA-000142-PIP02-09-M11 - paediatric investigation plan

concentrate of proteolytic enzymes in bromelain

Key facts

• Invented name:
  NexoBrid
• Active substance:
  concentrate of proteolytic enzymes in bromelain
• Therapeutic area:
  Other
• Decision number:
  P/0189/2021
• PIP number:
  EMEA-000142-PIP02-09-M11
• Pharmaceutical form(s):
  Powder and gel for gel
• Condition(s) / indication(s):
  Treatment for burns
• Route(s) of administration:
  Cutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/05/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMA/PE/0000182558
• Compliance opinion date:
  18/10/2024
• Compliance outcome:
  Positive

Decision

P/0189/2021 : EMA decision of 10 May 2021 on the acceptance of a modification of an agreed paediatric investigation plan for concentrate of proteolytic enzyme enriched in bromelain (NexoBrid), (EMEA-000142-PIP02-09-M11)

Adopted Reference Number: EMA/245223/2021