Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
IMFINZI 50 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear to opalescent, colourless to slightly yellow solution, free from visible particles. The solution has a pH of approximately 6.0 and an osmolality of approximately 400 mOsm/kg. |
Each mL of concentrate for solution for infusion contains 50 mg of durvalumab.
One vial of 2.4 mL of concentrate contains 120 mg of durvalumab.
One vial of 10 mL of concentrate contains 500 mg of durvalumab.
Durvalumab is produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Durvalumab |
Durvalumab is a fully human, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that selectively blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1). Durvalumab does not induce antibody dependent cell-mediated cytotoxicity (ADCC). Selective blockade of PD-L1/PD-1 and PD-L1/CD80 interactions enhances antitumour immune responses and increases T-cell activation. |
| List of Excipients |
|---|
|
Histidine |
Two pack sizes of IMFINZI are available:
2.4 ml (a total of 120 mg durvalumab) of concentrate in a Type 1 glass vial with an elastomeric stopper and a gray flip-off aluminium seal. Pack size of 1 vial.
10 ml (a total of 500 mg durvalumab) of concentrate in a Type 1 glass vial with an elastomeric stopper and a white flip-off aluminium seal. Pack size of 1 vial.
Not all pack sizes may be marketed.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
EU/1/18/1322/002 120 mg vial
EU/1/18/1322/001 500 mg vial
Date of first authorisation: 21 September 2018
Date of latest renewal: 24 April 2023
| Drug | Countries | |
|---|---|---|
| IMFINZI | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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