Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Theramex Ireland Limited, 3rd Floor Kilmore House, Park Lane, Spencer Dock, DO1 YE64 Dublin 1, Ireland
Livogiva 20 micrograms/80 microliters solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection. Colourless, clear solution. |
Each dose of 80 microliters contains 20 micrograms of teriparatide*.
Each pre-filled pen of 2.7 mL contains 675 micrograms of teriparatide (corresponding to 250 micrograms per mL).
* Teriparatide, rhPTH(1-34), produced in P. fluorescens, using recombinant DNA technology, is identical to the 34 N-terminal amino acid sequence of endogenous human parathyroid hormone.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Teriparatide |
Teriparatide (rhPTH(1-34)) is the active fragment (1-34) of endogenous human parathyroid hormone. Teriparatide is a bone formation agent to treat osteoporosis. The skeletal effects of teriparatide depend upon the pattern of systemic exposure. |
| List of Excipients |
|---|
|
Glacial acetic acid |
2.7 mL solution in cartridge (siliconised Type I glass) sealed at one end with a bromobutyl rubber plunger and at the other end crimp-sealed with a bi-layer combi-seal (polyisoprene/bromobutyl rubber laminate with aluminium over cap). The cartridges are an integral and non-replaceable part of the pen injector.
The pen injector is composed of a clear cartridge holder, white protective cap to cover the cartridge holder and injector body with a black injection button.
Livogiva is available in pack sizes of 1 or 3 pre-filled pens. Each pre-filled pen contains 28 doses of 20 micrograms (per 80 microliters).
Not all pack sizes may be marketed.
Theramex Ireland Limited, 3rd Floor Kilmore House, Park Lane, Spencer Dock, DO1 YE64 Dublin 1, Ireland
EU/1/20/1462/001-002
| Drug | Countries | |
|---|---|---|
| LIVOGIVA | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland |
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