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On 25 March 2021, 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 Benlysta. The marketing authorisation holder for this medicinal product is GlaxoSmithKline (Ireland) Limited.

The CHMP adopted a new indication as follows:1

Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti dsDNA and low complement) despite standard therapy (see section 5.1).

Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (see sections 4.2 and 5.1).

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.

1 New text in bold


Key facts

Agency product number
International non-proprietary name (INN) or common name
  • belimumab
Active substance
  • belimumab
Therapeutic area
Lupus Erythematosus, Systemic
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Date opinion adopted
Company name
GlaxoSmithKline (Ireland) Limited
Application type

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