EMEA-003555-PIP01-23 - paediatric investigation plan

alrefimotide

tapderimotide

riletamotide

Key facts

• Active substance:
  • alrefimotide
  • tapderimotide
  • riletamotide
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0140/2024
• PIP number:
  EMEA-003555-PIP01-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of mesothelioma
• 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:
  06/05/2024
• Compliance check done:
  No

Decision

P/0140/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for alrefimotide / tapderimotide / riletamotide, (EMEA- 003555-PIP01-23)

Adopted Reference Number: EMA/153122/2024