Kynamro

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mipomersen sodium

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-autorisation applicant
Genzyme Europe BV
Date of opinion
20/03/2013
Date of refusal of marketing authorisation
28/05/2013

Assessment history

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