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/63.1 KB)
First published: 14/02/2019
This EPAR was last updated on 12/06/2020
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 |
5
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Date of issue of marketing authorisation valid throughout the European Union |
14/11/2018
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Contact address |
Product information
20/05/2020 Emgality - EMEA/H/C/004648 - X/0004
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Pharmacotherapeutic group
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Analgesics
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Calcitonin gene-related peptide (CGRP) antagonists
Therapeutic indication
Therapeutic indication
Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.