DARZALEX 20 mg / mL concentrate for solution for infusion

Licence status
Authorised: 20/05/2016
Active substances
Daratumumab
Dosage Form
Concentrate for solution for infusion
Licence number
EU/1/16/1101/001-003
Licence holder
Janssen-Cilag International NV

Product documents

Licence information

ATC code
L01XC24 ZZZ Daratumumab
Legal supply status
Product subject to prescription which may not be renewed (A)
Place of sale
Supply through pharmacies only
Conditions of Licence
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing availability
Unknown
Advertising conditions
Advertising to healthcare professionals only
Licence issued
20/05/2016

Educational materials for healthcare professionals

Educational materials for patients