Emgality
galcanezumab
Table of contents
Overview
Emgality is a medicine used to prevent migraine in adults who have migraines at least 4 days a month. It contains the active substance galcanezumab.
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List item
Emgality : EPAR - Medicine overview (PDF/100.61 KB)
First published: 14/02/2019
EMA/658658/2018 -
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List item
Emgality : EPAR - Risk-management plan summary (PDF/237.76 KB)
First published: 14/02/2019
Last updated: 07/09/2023
Authorisation details
Product details | |
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Name |
Emgality
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Agency product number |
EMEA/H/C/004648
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Active substance |
Galcanezumab
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International non-proprietary name (INN) or common name |
galcanezumab
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Therapeutic area (MeSH) |
Migraine Disorders
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Anatomical therapeutic chemical (ATC) code |
N02
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Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Eli Lilly Nederland B.V.
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Revision |
10
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Date of issue of marketing authorisation valid throughout the European Union |
14/11/2018
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Contact address |
Papendorpseweg 83 |
Product information
01/09/2023 Emgality - EMEA/H/C/004648 - R/0023
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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Analgesics
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galcanezumab
Therapeutic indication
Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.