EMA/PE/0000235991 - paediatric investigation plan

etimumotide

imsamotide

Key facts

• Active substance:
  • etimumotide
  • imsamotide
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  EMA/PE/0000235991
• PIP number:
  EMA/PE/0000235991
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of melanoma
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Compliance check done:
  Nej

Decision

EMA/PE/0000235991 : EMA decision of 14 April 2025 on the granting of a product specific waiver for etimumotide, imsamotide

Adopted Reference Number: EMADOC-1700519818-2035298