EMEA-000142-PIP03-23 - 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/0334/2023
• PIP number:
  EMEA-000142-PIP03-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  • Treatment of diabetic foot ulcer
  • Treatment of venous leg ulcer
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/08/2023

Decision

P/0334/2023 : EMA decision of 9 August 2023 on the granting of a product specific waiver for concentrate of proteolytic enzymes enriched in bromelain (NexoBrid), (EMEA-000142-PIP03-23)

Reference Number: EMA/352825/2023