EMEA-002152-PIP02-17

Key facts

Invented name
Darzalex
Active substance
Daratumumab
Therapeutic area
Oncology
Decision number
P/0264/2017
PIP number
EMEA-002152-PIP02-17
Pharmaceutical form(s)
  • Solution for injection
  • Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of 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
W: decision granting a waiver in all age groups for all conditions/indications

Decision

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