EMEA-002745-PIP01-19 - 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/0169/2020
• PIP number:
  EMEA-002745-PIP01-19
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of Multiple Myeloma
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/05/2020
• Compliance check done:
  No

Decision

P/0169/2020: EMA decision of 13 May 2020 on the granting of a product specific waiver for 18-(p-[131I]-iodophenyl)octadecyl phosphocholine (EMEA-002745-PIP01-19)

Reference Number: EMA/241755/2020