EMEA-002152-PIP01-17

Key facts

Invented name
Darzalex
Active substance
Daratumumab
Therapeutic area
Oncology
Decision number
P/0180/2018
PIP number
EMEA-002152-PIP01-17
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
  • Subcutaneous use
  • Intravenous use
Contact for public enquiries
Janssen-Cilag International N.V.

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

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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