Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
FORSTEO 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*.
One pre-filled pen of 2.4 mL contains 600 micrograms of teriparatide (corresponding to 250 micrograms per mL).
* Teriparatide, rhPTH(1-34), produced in E. coli, 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 |
2.4 mL solution in cartridge (siliconised Type I glass) with a plunger (halobutyl rubber), disc seal (polyisoprene/bromobutyl rubber laminate)/aluminium assembled into a disposable pen.
FORSTEO is available in pack sizes of 1 or 3 pens. Each pen contains 28 doses of 20 micrograms (per 80 microliters).
Not all pack sizes may be marketed.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
EU/1/03/247/001-002
Date of first authorisation: 10 June 2003
Date of the latest renewal: 13 February 2013
| Drug | Countries | |
|---|---|---|
| FORSTEO | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom |
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