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