SAPHNELO Concentrate for solution for infusion Ref.[50047] Active ingredients: Anifrolumab

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: AstraZeneca AB, SE-151 85, Södertälje, Sweden

Product name and form

Saphnelo 300 mg concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion (sterile concentrate).

Clear to opalescent, colourless to slightly yellow, pH 5.9 solution.

Qualitative and quantitative composition

Each mL of concentrate for solution for infusion contains 150 mg of anifrolumab.

One vial of 2.0 mL of concentrate contains 300 mg of anifrolumab (150 mg/mL).

Anifrolumab is a human, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in mouse myeloma cells (NS0) by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Anifrolumab

Anifrolumab is a human immunoglobulin G1 kappa monoclonal antibody that binds to subunit 1 of the type I interferon receptor (IFNAR1) with high specificity and affinity. This binding inhibits type I IFN signalling thereby blocking the biologic activity of type I IFNs. Inhibition of type I IFN blocks plasma cell differentiation and normalises peripheral T-cell subsets, restoring the balance between adaptive and innate immunity that is dysregulated in SLE.
List of Excipients

Histidine
Histidine hydrochloride monohydrate
Lysine hydrochloride
Trehalose dihydrate
Polysorbate 80
Water for injections

Pack sizes and marketing

2.0 mL of concentrate in a clear type I glass vial with an elastomeric stopper and a gray flip-off aluminium seal.

Pack size of 1 vial.

Marketing authorization holder

AstraZeneca AB, SE-151 85, Södertälje, Sweden

Marketing authorization dates and numbers

EU/1/21/1623/001

Drugs

Drug Countries
SAPHNELO Austria, Australia, Canada, Estonia, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United States
 
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