EMEA-002152-PIP03-19

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: nreymond@its.jnj.com
Tel.: +31 621385718

Decision type
W: decision granting a waiver in all age groups for all conditions or indications

Decision

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