EMA — authorised 24 February 2009
- Marketing authorisation holder: Dr. Friedrich Eberth Arzneimittel GmbH
- Status: approved
🇪🇺 Fablyn in European Union
EMA authorised Fablyn on 24 February 2009
Marketing authorisations
EMA — authorised 24 February 2009
- Application: EMEA/H/C/000977
- Marketing authorisation holder: Dr. Friedrich Eberth Arzneimittel GmbH
- Local brand name: Fablyn
- Indication: Fablyn is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1). When determining the choice of Fablyn or other therapies, including oestrogens, for a postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
- Status: withdrawn
Fablyn 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 Fablyn approved in European Union?
Yes. EMA authorised it on 24 February 2009; EMA authorised it on 24 February 2009.
Who is the marketing authorisation holder for Fablyn in European Union?
Dr. Friedrich Eberth Arzneimittel GmbH holds the EU marketing authorisation.