Taltz

ixekizumab

Table of contents

Opinion

On 28 May 2020, 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 Taltz. The marketing authorisation holder for this medicinal product is Eli Lilly Nederland B.V.

The CHMP adopted a new indication as follows:1

Plaque psoriasis

Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Paediatric plaque psoriasis

Taltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for systemic therapy.

Psoriatic arthritis

Taltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies (see section 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

Name
Taltz
Agency product number
EMEA/H/C/003943
International non-proprietary name (INN) or common name
  • ixekizumab
Active substance
  • ixekizumab
Therapeutic area
Psoriasis
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
28/05/2020
Company name
Eli Lilly Nederland B.V.
Status
Positive
Application type
Post-authorisation

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