Refused
This medicine was refused authorisation for use in the European Union.
Overview
On 19 November 2015, the Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of the marketing authorisation for the medicinal product Solumarv, intended for the treatment of diabetes.
The company that applied for authorisation is Marvel Lifesciences Ltd. It can request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
This EPAR was last updated on 16/02/2016
Application details
Product details | |
---|---|
Name |
Solumarv
|
Active substance |
insulin human
|
International non-proprietary name (INN) or common name |
insulin human
|
Therapeutic area (MeSH) |
Diabetes Mellitus
|
Anatomical therapeutic chemical (ATC) code |
A10AB01
|
Biosimilar |
This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines. |
Application details | |
---|---|
Marketing-authorisation applicant |
Marvel Lifesciences Ltd
|
Date of opinion |
19/11/2015
|
Date of refusal of marketing authorisation |
11/02/2016
|
Assessment history
-
List item
Solumarv : EPAR - Public assessment report (PDF/1.55 MB)
Adopted
First published: 16/02/2016
Last updated: 16/02/2016
EMA/596513/2015 -
List item
Questions and answers on refusal of the marketing authorisation for Solumarv (insulin human) (PDF/71.87 KB)
Adopted
First published: 20/11/2015
Last updated: 20/11/2015
EMA/765377/2015 -