Eladynos Theramex Ireland Limited · Authorised · authorised 12 Dec 2022 · ATC H05AA04
Therapeutic indication (EMA)
Treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Active substance
Abaloparatide
- SFDA 1
- US FDA 1
- EMA 2
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Tymlos | 2 mg/ml | Solution for injection in pre-filled pen · Subcutaneous use | 1 Cartridge | SAR 1564.15 | NCE · Prescription | Labatec- Pharma S.A | Valid |
Indications — CHI Daman Drug Formulary
OSTEOPOROSIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| TYMLOS | 3.12MG/1.56ML (2MG/ML) | solution · subcutaneous | RADIUS | Prescription | 28 Apr 2017 |
EMA European Union — centrally authorised medicines
Eladynos Radius Health Ireland Ltd · Refused · ATC H05AA
Therapeutic indication (EMA)
Treatment of osteoporosis.
Safety signals and safety-related labeling changes
- US FDA 3 Aug 2026 TYMLOS — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.