LIBTAYO Concentrate for solution for infusion Ref.[8754] Active ingredients: Cemiplimab

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Regeneron Ireland Designated Activity Company (DAC), Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland

Product name and form

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.

Qualitative and quantitative composition

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 is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma.

List of Excipients

L-histidine
L-histidine monohydrochloride monohydrate
Sucrose
L-proline
Polysorbate 80
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Regeneron Ireland Designated Activity Company (DAC), Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland

Marketing authorization dates and numbers

EU/1/19/1376/001

Date of first authorisation: 28 June 2019

Drugs

Drug Countries
LIBTAYO Austria, Brazil, Canada, Cyprus, Estonia, Finland, France, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

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