Libtayo

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cemiplimab

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

Overview

Libtayo is a cancer medicine used on its own to treat adults with a type of skin cancer called cutaneous squamous cell carcinoma when the cancer is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). It is used in patients who cannot have surgery or treatment with radiation to cure their disease.

Libtayo contains the active substance cemiplimab.

This EPAR was last updated on 30/10/2019

Authorisation details

Product details
Name
Libtayo
Agency product number
EMEA/H/C/004844
Active substance
Cemiplimab
International non-proprietary name (INN) or common name
cemiplimab
Therapeutic area (MeSH)
Carcinoma, Squamous Cell
Anatomical therapeutic chemical (ATC) code
L01XC
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
Regeneron Ireland U.C.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
28/06/2019
Contact address

Europa House
Block 9 Harcourt Centre
Harcourt Street
Dublin
Ireland

Product information

06/09/2019 Libtayo - EMEA/H/C/004844 - IB/0001/G

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Libtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.

Assessment history

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