Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, The Netherlands
Emgality 120 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
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Solution for injection (injection). The solution is clear and colourless to slightly yellow. |
Each pre-filled pen contains 120 mg of galcanezumab in 1 mL.
Galcanezumab is a recombinant humanised monoclonal antibody produced in Chinese Hamster Ovary cells.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Galcanezumab |
Galcanezumab is a humanised IgG4 monoclonal antibody that binds calcitonin gene-related peptide (CGRP) thus preventing its biological activity. Elevated blood concentrations of CGRP have been associated with migraine attacks. |
| List of Excipients |
|---|
|
L-histidine |
1 mL of solution in a type I clear glass syringe. The syringe is encased in a disposable, single-dose pen. Packs of 1, 2 or 3 pre-filled pens. Not all pack sizes may be marketed.
The needle included in the pack is only suitable for sub-cutaneous injection.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, The Netherlands
EU/1/18/1330/001
EU/1/18/1330/002
EU/1/18/1330/005
Date of first authorisation: 14 November 2018
| Drug | Countries | |
|---|---|---|
| EMGALITY | Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, New Zealand, Poland, Romania, Turkey, United Kingdom, United States, South Africa |
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