Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Regeneron Ireland Designated Activity Company (DAC), One Warrington Place, Dublin 2, D02 HH27, Ireland
LIBTAYO 350 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless to pale yellow solution with a pH of 6.0 and osmolality between 300 and 360 mmol/kg. The solution may contain trace amounts of translucent to white particles in a single-use vial. |
One ml of concentrate contains 50 mg of cemiplimab.
Each vial contains 350 mg of cemiplimab in 7 ml of solution.
Cemiplimab is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Cemiplimab |
Cemiplimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with its ligands PD-L1 and PD-L2. Cemiplimab potentiates T cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands. |
| List of Excipients |
|---|
|
L-histidine |
LIBTAYO is provided in a 10 ml clear Type 1 glass vial, with a grey chlorobutyl stopper with FluroTec coating and seal cap with a flip-off button.
Each carton contains 1 vial.
Regeneron Ireland Designated Activity Company (DAC), One Warrington Place, Dublin 2, D02 HH27, Ireland
EU/1/19/1376/001
Date of first authorisation: 28 June 2019
Date of latest renewal: 01 July 2022
| Drug | Countries | |
|---|---|---|
| LIBTAYO | Austria, Brazil, Canada, Cyprus, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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