Eladynos

RSS

abaloparatide

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 22 March 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Eladynos, intended for the treatment of osteoporosis (a disease that makes bones fragile). The company that applied for authorisation is Radius International Ltd.

The company requested a re‑examination of the initial opinion. After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 26 July 2018.

This EPAR was last updated on 14/02/2019

Application details

Product details
Name
Eladynos
Active substance
abaloparatide
International non-proprietary name (INN) or common name
abaloparatide
Therapeutic area (MeSH)
Osteoporosis
Anatomical therapeutic chemical (ATC) code
H05AA
Application details
Marketing-authorisation applicant
Radius International Ltd
Date of opinion
26/07/2018
Date of refusal of marketing authorisation
07/01/2019

Assessment history

How useful was this page?

Add your rating