Refused
This medicine was refused authorisation for use in the European Union.
Overview
On 13 December 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Kynamro, intended for the treatment of patients with certain forms of familial hypercholesterolaemia. The company that applied for authorisation is Genzyme Europe B.V.
The applicant requested a re-examination of the opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 21 March 2013.
This EPAR was last updated on 17/06/2013
Application details
Product details | |
---|---|
Name |
Kynamro
|
Active substance |
mipomersen sodium
|
International non-proprietary name (INN) or common name |
mipomersen sodium
|
Therapeutic area (MeSH) |
Hypercholesterolemia
|
Anatomical therapeutic chemical (ATC) code |
C10AX11
|
Application details | |
---|---|
Marketing-authorisation applicant |
Genzyme Europe BV
|
Date of opinion |
21/03/2013
|
Date of refusal of marketing authorisation |
29/05/2013
|
Assessment history
-
List item
Kynamro : EPAR - Public assessment report (PDF/3.24 MB)
Adopted
First published: 17/06/2013
Last updated: 17/06/2013 -
List item
Questions and answers on the refusal of the marketing authorisation for Kynamro - Outcome of re-examination (PDF/142.74 KB)
Adopted
First published: 22/03/2013
Last updated: 22/03/2013
EMA/177547/2013 -
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List item
Questions and answers on refusal of the marketing authorisation for Kynamro (mipomersen) (PDF/92.46 KB)
First published: 14/12/2012
Last updated: 14/12/2012
EMA/792736/2012