Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
DARZALEX 20 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. The solution is colourless to yellow. |
Each 5 mL vial contains 100 mg of daratumumab (20 mg daratumumab per mL).
Each 20 mL vial contains 400 mg of daratumumab (20 mg daratumumab per mL).
Daratumumab is a human monoclonal IgG1Îș antibody against CD38 antigen, produced in a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology.
Excipients with known effect: Each 5 mL and 20 mL vial of DARZALEX contains 0.4 mmol and 1.6 mmol (9.3 mg and 37.3 mg) sodium, respectively.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Daratumumab |
Daratumumab is an IgG1Îș human monoclonal antibody (mAb) that binds to the CD38 protein expressed at a high level on the surface of multiple myeloma tumour cells, as well as other cell types and tissues at various levels. CD38 protein has multiple functions such as receptor mediated adhesion, signalling and enzymatic activity. Daratumumab has been shown to potently inhibit the in vivo growth of CD38-expressing tumour cells. |
| List of Excipients |
|---|
|
Glacial acetic acid |
5 mL concentrate in a Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 100 mg of daratumumab. Pack size of 1 vial.
20 mL concentrate in a Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 400 mg of daratumumab. Pack size of 1 vial.
DARZALEX is also supplied as an initiation pack containing 11 vials: (6 × 5 mL vials + 5 × 20 mL vials).
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
EU/1/16/1101/001
EU/1/16/1101/002
EU/1/16/1101/003
Date of first authorisation: 20 May 2016
Date of latest renewal: 24 April 2017
| Drug | Countries | |
|---|---|---|
| DARZALEX | Austria, Australia, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States |
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