On 25 January 2024 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Aspaveli. The marketing authorisation holder for this medicinal product is Swedish Orphan Biovitrum AB (publ).
The CHMP adopted an extension to the existing indication to include patients with paroxysmal nocturnal haemoglobinuria who have haemolytic anaemia and have not had previous treatment with a C5 inhibitor. For information, the full indication will therefore be as follows:
Aspaveli is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least 3 months have haemolytic anaemia.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1New text in bold, removed text as strikethrough
CHMP summary of positive opinion for Aspaveli
English (EN) (129.3 KB - PDF)