Eladynos (abaloparatide)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- abaloparatide
- Company
- Theramex Ireland Limited
- Status
- Authorised
- Therapeutic area
- Osteoporosis, Postmenopausal; Osteoporosis
- CHMP opinion
- Thu 13 Oct 2022
- EU approval
- Mon 12 Dec 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005928
- ATC
- H05AA04
- Official record
- www.ema.europa.eu
Indication
Treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Eladynos Refused · Radius Health Ireland Ltd
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.