EMA/PE/0000183758 - paediatric investigation plan

zimislecel

Key facts

• Active substance:
  zimislecel
• Therapeutic area:
  Endocrine disorders
• Decision number:
  EMA/PE/0000183758
• PIP number:
  EMA/PE/0000183758
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of type 1 diabetes in individuals with impaired awareness of hypoglycaemia resulting in recurrent severe hypoglycaemia
• Route(s) of administration:
  Intraportal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000183758 : EMA decision of 6 December 2024 on the granting of a product specific waiver for zimislecel

Adopted Reference Number: EMADOC-1700519818-1793563