Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
Terrosa 20 micrograms/80 microliters solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Colourless, clear solution for injection with a pH of 3.8–4.5. |
Each dose of 80 microliters contains 20 micrograms of teriparatide*.
One cartridge of 2.4 mL of solution 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 |
3 mL cartridge (siliconised Type I glass), with a plunger stopper and disc seal (aluminium and rubber liner seals), packed in a plastic tray sealed with lid foil and packed in a carton.
Each cartridge contains 2.4 mL of solution corresponding to 28 doses of 20 micrograms (per 80 microliters).
Terrosa 20 micrograms/80 microliters solution for injection:
1 or 3 cartridges.
Terrosa cartridge and pen pack:
1 carton of Terrosa cartridge (containing 1 cartridge) and 1 carton of Terrosa Pen (containing 1 pen).
Not all pack sizes may be marketed.
Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
EU/1/16/1159/001 [1 cartridge]
EU/1/16/1159/002 [3 cartridges]
EU/1/16/1159/003 [cartridge and pen pack]
Date of first authorisation: 04 January 2017
| Drug | Countries | |
|---|---|---|
| TERROSA | Austria, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom |
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