Solution for injection in pre-filled pen for the treatment of osteoporosis in postmenopausal women at high risk for fracture
Public Summary SwissPAR dated 28.06.2024
Tymlos® (active substance: abaloparatide)
Authorisation in Switzerland: 7 March 2024
Information on authorisation
The medicinal product Tymlos, containing the active substance abaloparatide, is used for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
Osteoporosis a widespread disease characterised by reduced bone density, compromised bone strength, and an increased risk of fracture.
In deciding whether to authorise the medicinal product Tymlos, Swissmedic took into account the assessments of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), and the corresponding medicinal product information texts.
Since the assessment of the clinical data was based on the assessment reports of the foreign authorities, the preconditions for a SwissPAR (Swiss Public Assessment Report – a detailed report for professionals) and a resulting Public Summary SwissPAR are not met. Swissmedic refers to the authorisation of the foreign reference authorities.
Further information on the medicinal product
At the time of publication of the Public Summary SwissPAR for Tymlos, the Information for healthcare professionals and the Patient information (package leaflet) were not yet available. As soon as the medicine becomes available in Switzerland, the Information for healthcare professionals and the Patient information will be made available on the following website: www.swissmedicinfo.ch
Healthcare professionals can answer any further questions.
Printable version
Tymlos® (active substance: abaloparatide) (PDF, 403 kB, 28.06.2024)First authorisation
The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Public Summary SwissPAR.
Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals.
New findings that could impair the quality, efficacy or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.