EMEA-002745-PIP02-20 - paediatric investigation plan

18-(p-[131I]-iodophenyl)octadecyl phosphocholine

Key facts

• Active substance:
  18-(p-[131I]-iodophenyl)octadecyl phosphocholine
• Therapeutic area:
  Oncology
• Decision number:
  P/0011/2021
• PIP number:
  EMEA-002745-PIP02-20
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of lymphoplasmacytic lymphoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/01/2021
• Compliance check done:
  No

Decision

P/0011/2021 : 28 January 2021 on the granting of a product specific waiver for 18-(p-[131I]-iodophenyl)octadecyl phosphocholine (EMEA-002745-PIP02-20)

Adopted Reference Number: EMA/694634/2020