EMGALITY Solution for injection Ref.[7656] Active ingredients: Galcanezumab

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, The Netherlands

Product name and form

Emgality 120 mg solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection (injection).

The solution is clear and colourless to slightly yellow.

Qualitative and quantitative composition

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
L-histidine hydrochloride monohydrate
Polysorbate 80
Sodium chloride
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, The Netherlands

Marketing authorization dates and numbers

EU/1/18/1330/001

EU/1/18/1330/002

EU/1/18/1330/005

Date of first authorisation: 14 November 2018

Drugs

Drug Countries
EMGALITY Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, New Zealand, Poland, Romania, Turkey, United Kingdom, United States, South Africa

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