SONDELBAY Solution for injection Ref.[50037] Active ingredients: Teriparatide

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Accord Healthcare S.L.U., World Trade Centre, Moll de Barcelona s/n, Edifici Est, 6ยช Planta, 08039, Barcelona, Spain

Product name and form

Sondelbay 20 micrograms/80 microliters solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection (injection).

Colourless, clear solution.

Qualitative and quantitative composition

Each dose contains 20 micrograms of teriparatide* in 80 microliters. One pre-filled pen of 2.4 mL contains 600 micrograms of teriparatide. Each millilitre of the solution for injection contains 250 micrograms of teriparatide.

* Teriparatide, rhPTH(1-34), produced in Escherichia. 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
Sodium acetate (anhydrous)
Mannitol
Metacresol
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

2.4 mL solution in cartridge (siliconised Type I glass) with a plunger (bromobutyl rubber), disc seal (bromobutyl lined aluminium seals), assembled into a disposable pen.

Sondelbay is available in pack sizes of 1 pre-filled pen 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.

Marketing authorization holder

Accord Healthcare S.L.U., World Trade Centre, Moll de Barcelona s/n, Edifici Est, 6ยช Planta, 08039, Barcelona, Spain

Marketing authorization dates and numbers

EU/1/22/1628/001
EU/1/22/1628/002

Drugs

Drug Countries
SONDELBAY Austria, Estonia, Finland, France, Lithuania, Poland

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