Key facts

Invented name
Darzalex
Active Substance
Daratumumab
Therapeutic area
Oncology
Decision number
P/0206/2019
PIP number
EMEA-002152-PIP02-17-M01
Pharmaceutical form(s)
  • Solution for injection
  • Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of lymphoid malignancies (except mature B-cell neoplasms)
Route(s) of administration
  • Intravenous use
  • Subcutaneous use
Contact for public enquiries

Janssen-Cilag International N.V.

E-mail: nbuhl@its.jnj.com
Tel. +353 8574 46696

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

P/0206/2019: EMA decision of 12 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for daratumumab (Darzalex) (EMEA-002152-PIP01-17-M01)

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