Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: EUSA Pharma (Netherlands) B.V., Beechavenue 54, 1119PW Schiphol-Rijk, Netherlands
Qarziba 4.5 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. Clear, colourless liquid. |
1 mL of concentrate contains 4.5 mg dinutuximab beta.
Each vial contains 20 mg dinutuximab beta in 4.5 mL.
Dinutuximab beta is a mouse-human chimeric monoclonal IgG1 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dinutuximab |
Dinutuximab is a monoclonal chimeric antibody composed of murine variable heavy and light chain regions and the human constant region for the heavy chain IgG1 and light chain kappa. Dinutuximab reacts specifically with the ganglioside GD2, which is highly expressed on the surface of neuroblastoma cells and minimally expressed on the surface of normal human neurons, peripheral pain fibres, and skin melanocytes. |
| List of Excipients |
|---|
|
Histidine |
Clear Type I glass vial (6 mL) with a halobutyl rubber stopper and aluminium flip-off cap, containing a minimum extractable volume of 4.5 mL concentrate for solution for infusion.
Each carton contains 1 vial.
EUSA Pharma (Netherlands) B.V., Beechavenue 54, 1119PW Schiphol-Rijk, Netherlands
EU/1/17/1191/001
Date of first authorisation: 08 May 2017
| Drug | Countries | |
|---|---|---|
| QARZIBA | Austria, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom |
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