Emgality

galcanezumab

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

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.

: Emgality is injected under the skin using a pre-filled syringe or pen. Patients can inject the medicine themselves after being trained.
Treatment should be started with the injection of the content of 2 syringes (or pens), followed a month later by single injections given every month. Doctors should review treatment after 3 months and only continue it if patients benefit from it.
Emgality can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of migraine. For more information about using Emgality, see the package leaflet or contact your doctor or pharmacist.

: A substance called CGRP has been shown to be involved in the development of migraine by widening blood vessels in the brain. The active substance of Emgality, galcanezumab, is a monoclonal antibody (a type of protein) designed to attach to and block CGRP, thereby helping blood vessels to return to their normal size. This will stop the symptoms of migraine.

: Emgality was shown to be effective at reducing the number of days patients suffer migraines in 3 main studies. Overall, Emgality led to 2 fewer days with migraines per month compared with placebo (a dummy treatment).
In two studies involving 1,784 patients who had migraines between 4 and 14 days a month, those treated with Emgality had 4 or 5 fewer days with migraines per month, compared with 2 to 3 fewer days for patients on a placebo injection.
In a third study of 1,117 patients who had migraines for more than 15 days a month on average (chronic migraine), those treated with Emgality had on average around 5 fewer days with migraines per month compared with around 3 fewer days for patients on placebo.

: The most common side effects with Emgality (which may affect more than 1 in 10 people) are reactions at the site of injection such as pain, redness, itching, bruising or swelling.
For the full list of side effects and restrictions of Emgality, see the package leaflet.

: Emgality was shown to be more effective than placebo at reducing the number of days of migraine, although the size of the effect is limited particularly for patients with chronic migraine.
The side effects seen with Emgality are considered manageable with most being mild or moderate in severity.
The European Medicines Agency therefore decided that Emgality’s benefits are greater than its risks and it can be authorised for use in the EU.

: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emgality have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Emgality are continuously monitored. Side effects reported with Emgality are carefully evaluated and any necessary action taken to protect patients.

: Emgality received a marketing authorisation valid throughout the EU on 14 November 2018.

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Emgality : EPAR - Medicine overview (PDF/100.61 KB)

First published: 14/02/2019
EMA/658658/2018
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  (PDF/98.09 KB)
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- Danish
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- German
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- Hungarian
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- Italian
  (PDF/71.79 KB)
- Latvian
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- Lithuanian
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- Maltese
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- Polish
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Emgality : EPAR - Risk-management plan summary (PDF/63.1 KB)

First published: 14/02/2019

More detail is available in the summary of product characteristics

This EPAR was last updated on 12/06/2020

Authorisation details

Product details
Name	Emgality
Agency product number	EMEA/H/C/004648
Active substance	Galcanezumab
International non-proprietary name (INN) or common name	galcanezumab
Therapeutic area (MeSH)	Migraine Disorders
Anatomical therapeutic chemical (ATC) code	N02
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
Marketing-authorisation holder	Eli Lilly Nederland B.V.
Revision	5
Date of issue of marketing authorisation valid throughout the European Union	14/11/2018
Contact address	Papendorpseweg 83 3528 BJ Utrecht Netherlands

Product information

20/05/2020 Emgality - EMEA/H/C/004648 - X/0004

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Emgality : EPAR - Product information (PDF/1.02 MB)

First published: 14/02/2019
Last updated: 28/04/2020
- Bulgarian
  (PDF/1.19 MB)
- Croatian
  (PDF/1.14 MB)
- Czech
  (PDF/1.07 MB)
- Danish
  (PDF/1 MB)
- Dutch
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- Estonian
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- Finnish
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- French
  (PDF/1.24 MB)
- German
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- Greek
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- Hungarian
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- Icelandic
  (PDF/980.05 KB)
- Italian
  (PDF/1.05 MB)
- Latvian
  (PDF/1013.28 KB)
- Lithuanian
  (PDF/1.08 MB)
- Maltese
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- Norwegian
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- Polish
  (PDF/1.33 MB)
- Portuguese
  (PDF/1.06 MB)
- Romanian
  (PDF/1.27 MB)
- Slovak
  (PDF/1.13 MB)
- Slovenian
  (PDF/1.05 MB)
- Spanish
  (PDF/959.5 KB)
- Swedish
  (PDF/971.73 KB)

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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Emgality : EPAR - All authorised presentations (PDF/18.45 KB)

First published: 14/02/2019
Last updated: 01/03/2019
- Bulgarian
  (PDF/55.57 KB)
- Croatian
  (PDF/29.35 KB)
- Czech
  (PDF/38.79 KB)
- Danish
  (PDF/17.57 KB)
- Dutch
  (PDF/19.33 KB)
- Estonian
  (PDF/20.22 KB)
- Finnish
  (PDF/19.54 KB)
- French
  (PDF/18.05 KB)
- German
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- Greek
  (PDF/38.17 KB)
- Hungarian
  (PDF/35.08 KB)
- Icelandic
  (PDF/16.48 KB)
- Italian
  (PDF/19.8 KB)
- Latvian
  (PDF/40.79 KB)
- Lithuanian
  (PDF/27.83 KB)
- Maltese
  (PDF/35.22 KB)
- Norwegian
  (PDF/20.26 KB)
- Polish
  (PDF/37.26 KB)
- Portuguese
  (PDF/20.29 KB)
- Romanian
  (PDF/52.3 KB)
- Slovak
  (PDF/37.46 KB)
- Slovenian
  (PDF/25.98 KB)
- Spanish
  (PDF/17.66 KB)
- Swedish
  (PDF/48.21 KB)

Pharmacotherapeutic group

Analgesics
Calcitonin gene-related peptide (CGRP) antagonists

Therapeutic indication

Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.

Assessment history

Changes since initial authorisation of medicine

List item

Emgality : EPAR - Procedural steps taken and scientific information after authorisation (PDF/158.31 KB)

First published: 01/03/2019
Last updated: 28/04/2020
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Questions and answers on the refusal of a change to the marketing authorisation for Emgality (galcanezumab) (PDF/116.49 KB)

Adopted

First published: 28/02/2020
Last updated: 12/06/2020
EMA/95744/2020
- Bulgarian
  (PDF/145.79 KB)
- Croatian
  (PDF/142.49 KB)
- Czech
  (PDF/144.07 KB)
- Danish
  (PDF/122.05 KB)
- Dutch
  (PDF/121.21 KB)
- Estonian
  (PDF/120.02 KB)
- Finnish
  (PDF/120.21 KB)
- French
  (PDF/123.15 KB)
- German
  (PDF/124.24 KB)
- Greek
  (PDF/147.82 KB)
- Hungarian
  (PDF/171.29 KB)
- Italian
  (PDF/120.6 KB)
- Latvian
  (PDF/162.84 KB)
- Lithuanian
  (PDF/145.98 KB)
- Maltese
  (PDF/144.98 KB)
- Polish
  (PDF/142.94 KB)
- Portuguese
  (PDF/122.76 KB)
- Romanian
  (PDF/141.83 KB)
- Slovak
  (PDF/143.9 KB)
- Slovenian
  (PDF/140.5 KB)
- Spanish
  (PDF/121.79 KB)
- Swedish
  (PDF/121.28 KB)
List item

Emgality-H-C-PSUSA-00010733-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/68.14 KB)

First published: 11/12/2019
EMA/601092/2019

Emgality

Table of contents

Overview

Emgality : EPAR - Medicine overview (PDF/100.61 KB)

Emgality : EPAR - Risk-management plan summary (PDF/63.1 KB)

Authorisation details

Product information

Emgality : EPAR - Product information (PDF/1.02 MB)

Contents

Emgality : EPAR - All authorised presentations (PDF/18.45 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Emgality : EPAR - Procedural steps taken and scientific information after authorisation (PDF/158.31 KB)

Questions and answers on the refusal of a change to the marketing authorisation for Emgality (galcanezumab) (PDF/116.49 KB)

Emgality-H-C-PSUSA-00010733-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/68.14 KB)

Initial marketing-authorisation documents

Emgality-H-C-04648-X-0004 : EPAR - Refusal public assessment report (PDF/3.3 MB)

Emgality : EPAR - Public assessment report (PDF/5.48 MB)

Summary of opinion for Emgality (PDF/105.73 KB)

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Emgality

Table of contents

Overview

Emgality : EPAR - Medicine overview (PDF/100.61 KB)

Emgality : EPAR - Risk-management plan summary (PDF/63.1 KB)

Authorisation details

Product information

Emgality : EPAR - Product information (PDF/1.02 MB)

Contents

Emgality : EPAR - All authorised presentations (PDF/18.45 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Emgality : EPAR - Procedural steps taken and scientific information after authorisation (PDF/158.31 KB)

Questions and answers on the refusal of a change to the marketing authorisation for Emgality (galcanezumab) (PDF/116.49 KB)

Emgality-H-C-PSUSA-00010733-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/68.14 KB)

Initial marketing-authorisation documents

Emgality-H-C-04648-X-0004 : EPAR - Refusal public assessment report (PDF/3.3 MB)

Emgality : EPAR - Public assessment report (PDF/5.48 MB)

Summary of opinion for Emgality (PDF/105.73 KB)

News

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