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MA (EU) number (Invented) Strength Pharmaceutical Route of Immediate Content Pack size

name Form Administration Packaging (concentration)

EU/1/16/1101/001 Darzalex 20 mg/ml Concentrate for Intravenous use vial (glass) 5 ml 1 vial
solution for infusion

EU/1/16/1101/002 Darzalex 20 mg/ml Concentrate for Intravenous use vial (glass) 20 ml 1 vial
solution for infusion

EU/1/16/1101/003 Darzalex 20 mg/ml Concentrate for Intravenous use Vial (glass) 5 ml + 20 ml Initiation pack: 11 vials
solution for infusion (6 x 5 ml vials + 5 x 20 ml vials)

EU/1/16/1101/004 Darzalex 1800 mg Solution for injection Subcutaneous use Vial (glass) 15 ml 1 vial
(120 mg/ml)

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