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 | |
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Marketing-authorisation applicant |
Radius Health Ireland Ltd
|
Date of opinion |
26/07/2018
|
Date of refusal of marketing authorisation |
07/01/2019
|