Solumarv

RSS

insulin human

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
BiosimilarBiosimilar

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

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