IMFIZI Concentrate for solution for infusion Ref.[8680] Active ingredients: Durvalumab

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden

Product name and form

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.

Qualitative and quantitative composition

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). 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
Histidine hydrochloride monohydrate
Trehalose dihydrate
Polysorbate 80
Water for injections

Pack sizes and marketing

2.4 mL of concentrate in a Type 1 glass vial with an elastomeric stopper and a gray flip-off aluminium seal containing 120 mg durvalumab. Pack size of 1 vial.

10 mL of concentrate in a Type 1 glass vial with an elastomeric stopper and a white flip-off aluminium seal containing 500 mg durvalumab. Pack size of 1 vial.

Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Marketing authorization dates and numbers

EU/1/18/1322/002 120 mg vial
EU/1/18/1322/001 500 mg vial

Date of first authorisation: 21 September 2018

Drugs

Drug Countries
IMFINZI Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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