PROLIA Solution for injection

Active ingredients: Denosumab

Product name and form

Prolia 60 mg solution for injection in pre-filled syringe.

Pharmaceutical Form

Solution for injection (injection).

Clear, colourless to slightly yellow solution.

Qualitative and quantitative composition

Each pre-filled syringe contains 60 mg of denosumab in 1 mL of solution (60 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: This medicine contains 47 mg sorbitol in each mL of solution.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

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*
Sodium hydroxide (for pH adjustment)*
Sorbitol (E420)
Polysorbate 20
Water for injections

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

Pack sizes and marketing

One mL solution in a single use pre-filled syringe made from type I glass with stainless steel 27 gauge needle, with or without needle guard.

The needle cover of the pre-filled syringe contains dry natural rubber, which is a derivative of latex (see section 4.4).

Pack size of one pre-filled syringe, presented in blistered (pre-filled syringe with or without a needle guard) or unblistered packaging (pre-filled syringe without a needle guard only).

Not all pack sizes may be marketed.

Marketing authorization holder

Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands

Marketing authorization dates and numbers

EU/1/10/618/001
EU/1/10/618/002
EU/1/10/618/003

Date of first authorisation: 26 May 2010
Date of latest renewal: 15 January 2015

Drugs

Drug
Countries
Austria, Australia, Brazil, Canada, Cyprus, Spain, France, Hong Kong, Ireland, Lithuania, Netherlands, Singapore, United Kingdom, United States