Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark
VYEPTI 100 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Concentrate for solution for infusion. The concentrate for solution for infusion is clear to slightly opalescent, colourless to brownish-yellow with a pH of 5.5-6.1 and osmolality of 290-350 mOsm/kg. |
Each vial of concentrate contains 100 mg eptinezumab per mL.
Eptinezumab is a humanized monoclonal antibody produced in Pichia pastoris yeast cells.
Excipient(s) with known effect:
This medicinal product contains 40.5 mg of sorbitol in each mL.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Eptinezumab |
Eptinezumab is a recombinant humanized immunoglobulin G1 (IgG1) antibody that binds to α- and β-forms of human calcitonin gene-related peptide (CGRP) ligand with low picomolar affinity. Eptinezumab prevents the activation of the CGRP receptors and hence the downstream cascade of physiological events linked to initiation of migraine attacks. |
| List of Excipients |
|---|
|
Sorbitol (E420) |
4 mL type I glass vial with chlorobutyl rubber stopper. The vial stopper is made without natural rubber latex.
Each carton contains one vial.
H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark
EU/1/21/1599/001
| Drug | Countries | |
|---|---|---|
| VYEPTI | Austria, Estonia, Spain, France, Israel, Lithuania, Poland, Romania, United States |
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