Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Theramex Ireland Limited, 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland
Eladynos 80 micrograms/dose solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Colourless, clear solution. |
Each dose (40 microliters) contains 80 micrograms of abaloparatide.
Each pre-filled pen contains 3 mg of abaloparatide in 1.5 mL of solution (corresponding to 2 milligrams per mL).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Abaloparatide |
Abaloparatide is a 34 amino acid peptide that shares 41% homology to parathyroid hormone [PTH] and 76% homology to parathyroid hormone related peptide [PTHrP(1-34)], and is an activator of the PTH1 receptor signalling pathway. Abaloparatide stimulates new bone formation on trabecular and cortical bone surfaces by stimulation of osteoblastic activity. Abaloparatide causes transient and limited increases in bone resorption and increases bone density. |
| List of Excipients |
|---|
|
Phenol |
Cartridge (siliconised Type I glass) with a plunger (chlorobutyl rubber), crimp cap (bromobutyl rubber seal)/aluminium assembled into a disposable pen.
Eladynos is available in pack sizes of 1 or 3 pre-filled pens.
Each pre-filled pen contains 1.5 mL of solution (30 doses).
Not all pack sizes may be marketed.
Theramex Ireland Limited, 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland
EU/1/22/1706/001
EU/1/22/1706/002
Date of first authorisation: 12 December 2022
| Drug | Countries | |
|---|---|---|
| ELADYNOS | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania |
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