EMEA-002152-PIP03-19 - paediatric investigation plan

Daratumumab

Key facts

• Invented name:
  Darzalex
• Active Substance:
  Daratumumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0116/2020
• PIP number:
  EMEA-002152-PIP03-19
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of systemic light chain amyloidosis
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Contact for public enquiries:

  Janssen-Cilag International N.V.

  E-mail: [e-mail]; Tel.: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  18/03/2020

Decision

P/0116/2020: EMA decision of 18 March 2020 on the granting of a product specific waiver for daratumumab (Darzalex), (EMEA-002152-PIP03-19)

AdoptedReference Number: EMA/124393/2020