WYOST Solution for injection Ref.[110543] Active ingredients: Denosumab

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Sandoz GmbH, Biochemiestr. 10, 6250 Kundl, Austria

Product name and form

Wyost 120 mg solution for injection.

Pharmaceutical Form

Solution for injection (injection).

Clear to slightly opalescent, colourless to slightly yellowish or slightly brownish solution with a pH between 4.9 and 5.5 and an osmolality of 245–345 mOsmol/kg.

Qualitative and quantitative composition

Each vial contains 120 mg of denosumab in 1.7 mL of solution (70 mg/mL).

Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (Chinese hamster ovary cells) by recombinant DNA technology.

Excipient with known effect: Each 1.7 mL of solution contains 78.9 mg sorbitol (E420).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Denosumab

Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing activation of its receptor, RANK, on the surface of osteoclast precursors and osteoclasts. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption in cortical and trabecular bone.
List of Excipients

Acetic acid, glacial*
Sorbitol (E420)
Polysorbate 20
Sodium hydroxide (for pH adjustment)*
Hydrochloric acid (for pH adjustment)
Water for injections

* Acetate buffer is formed by mixing acetic acid with sodium hydroxide

Pack sizes and marketing

1.7 mL solution in a single use vial (type I glass) with stopper (fluoropolymer coated elastomeric) and seal (aluminium) with flip-off cap.

Pack size of one vial.

Marketing authorization holder

Sandoz GmbH, Biochemiestr. 10, 6250 Kundl, Austria

Marketing authorization dates and numbers

EU/1/24/1812/001

Drugs

Drug Countries
WYOST Canada, Lithuania, United States
 
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