Lympreva

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dasiprotimut-t

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 23 April 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Lympreva, intended for the treatment of patients with follicular non-Hodgkin’s lymphoma.

The company that applied for authorisation is Biovest Europe Ltd. It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.

This EPAR was last updated on 17/07/2015

Application details

Product details
Name
Lympreva
Active substance
dasiprotimut-t
International non-proprietary name (INN) or common name
dasiprotimut-t
Therapeutic area (MeSH)
Lymphoma, Non-Hodgkin
Anatomical therapeutic chemical (ATC) code
L03AX
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Application details
Marketing-autorisation applicant
Biovest Europe Ltd
Date of opinion
23/04/2015
Date of refusal of marketing authorisation
03/07/2015

Assessment history

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