EMA — authorised 3 April 2018
- Application: EMEA/H/C/004157
- Marketing authorisation holder: Radius Health Ireland Ltd
- Local brand name: Eladynos
- Indication: Treatment of osteoporosis.
- Status: rejected
🇪🇺 Tymlos in European Union
EMA authorised Tymlos on 3 April 2018
Marketing authorisations
EMA — authorised 12 December 2022
- Marketing authorisation holder: Radius Health Ireland Ltd
- Status: approved
EMA — authorised 12 December 2022
- Application: EMEA/H/C/005928
- Marketing authorisation holder: Theramex Ireland Limited
- Local brand name: Eladynos
- Indication: Treatment of osteoporosis in postmenopausal women at increased risk of fracture.
- Status: approved
Tymlos in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Bone approved in European Union
Frequently asked questions
Is Tymlos approved in European Union?
Yes. EMA authorised it on 3 April 2018; EMA authorised it on 12 December 2022; EMA authorised it on 12 December 2022.
Who is the marketing authorisation holder for Tymlos in European Union?
Radius Health Ireland Ltd holds the EU marketing authorisation.