IMJUDO Concentrate for solution for infusion Ref.[50776] Active ingredients: Tremelimumab

Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden

Product name and form

IMJUDO 20 mg/ml concentrate for solution for infusion.

Pharmaceutical Form
Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless to slightly yellow solution, free from or practically free from visible particles. The solution has a pH of approximately 5.5 and an osmolality of approximately 285 mOsm/kg.

Qualitative and quantitative composition

Each mL of concentrate for solution for infusion contains 20 mg of tremelimumab.

One vial of 1.25 ml of concentrate contains 25 mg of tremelimumab.

One vial of 15 ml of concentrate contains 300 mg of tremelimumab.

Tremelimumab is a human anti-CTLA-4 immunoglobulin G2 IgG2a monoclonal antibody produced in murine myeloma cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Tremelimumab	Tremelimumab is a selective, fully human IgG2 antibody that blocks CTLA-4 interaction with CD80 and CD86, thus enhancing T-cell activation and proliferation, resulting in increased T-cell diversity and enhanced antitumour activity. Cytotoxic T lymphocyte-associated antigen (CTLA-4) is primarily expressed on the surface of T lymphocytes.

List of Excipients
Histidine Histidine hydrochloride monohydrate Trehalose dihydrate Disodium edetate dihydrate Polysorbate 80 Water for injections

Pack sizes and marketing

Two pack sizes of IMJUDO are available:

1.25 ml (a total of 25 mg tremelimumab) concentrate in a Type I glass vial with an elastomeric stopper and a violet flip-off aluminum seal. Pack size of 1 single-dose vial.
15 ml (a total of 300 mg tremelimumab) concentrate in a Type I glass vial with an elastomeric stopper and a dark blue flip-off aluminum seal. Pack size of 1 single-dose vial.

Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Marketing authorization dates and numbers

EU/1/22/1713/001 25 mg vial
EU/1/22/1713/002 300 mg vial

Drugs

Drug	Countries
IMJUDO	Austria, Estonia, France, Croatia, Ireland, Italy, Japan, Lithuania, Romania, United Kingdom, United States

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