Tecvayli

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teclistamab

Authorised
This medicine is authorised for use in the European Union.

Overview

Tecvayli is a cancer medicine used to treat adults with multiple myeloma (a cancer of the bone marrow). It can be used in patients who have received at least three previous treatments for their cancer, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment.

Tecvayli contains the active substance teclistamab.

This EPAR was last updated on 20/10/2022

Authorisation details

Product details
Name
Tecvayli
Agency product number
EMEA/H/C/005865
Active substance
Teclistamab
International non-proprietary name (INN) or common name
teclistamab
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L01F
Additional monitoringAdditional 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.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
Janssen-Cilag International N.V.
Date of issue of marketing authorisation valid throughout the European Union
23/08/2022
Contact address

Turnhoutseweg 30
2340 Beerse
Antwerp
Belgium

Product information

Tecvayli - EMEA/H/C/005865 -

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

TECVAYLI is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Assessment history

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