EMEA-003616-PIP01-24 - paediatric investigation plan

tarumase

Key facts

• Active substance:
  tarumase
• Therapeutic area:
  Injury, poisoning and procedural complications
• Decision number:
  P/0310/2024
• PIP number:
  EMEA-003616-PIP01-24
• Pharmaceutical form(s):
  Gel
• Condition(s) / indication(s):
  Treatment of chronic wounds
• Route(s) of administration:
  Cutaneous use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  16/08/2024
• Compliance check done:
  No

Decision

P/0310/2024: EMA decision of 16 August 2024 on the refusal of a product specific waiver for tarumase (EMEA-003616-PIP01-24)

Adopted Reference Number: EMA/364891/2024