Aimovig

erenumab

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An overview of Aimovig and why it is authorised in the EU

What is Aimovig and what is it used for?

Aimovig is a medicine used to prevent migraine in adults who have migraines at least 4 days a month.

Aimovig contains the active substance erenumab.

How is Aimovig used?

Aimovig is injected under the skin using a pre-filled syringe or pen. Patients can inject the medicine themselves after being trained.

The recommended dose is 70 mg every 4 weeks as a single injection. Some patients may benefit from a dose of 140 mg every 4 weeks, given as two injections of 70 mg.

Aimovig can only be obtained with a prescription and treatment should be started by a doctor experienced in the diagnosis and treatment of migraine. For more information about using Aimovig, see the package leaflet or contact your doctor or pharmacist.

How does Aimovig work?

A chemical messenger called CGRP has been shown to be involved in the development of migraine. Aimovig is a monoclonal antibody (a type of protein) designed to attach to a receptor (target) for CGRP on body’s cells. By attaching to this receptor, the medicine stops CGRP from attaching to it and causing migraine.

What benefits of Aimovig have been shown in studies?

Aimovig is effective at reducing the number of days patients suffer migraines. In a study of 667 patients who had migraines 18 days a month on average, those treated with Aimovig had 7 fewer days with migraines per month, compared with 4 fewer days for patients on placebo.

In a second study of 955 patients who had migraines 8 days a month on average, those treated with Aimovig had on average 3 to 4 fewer days with migraines per month compared with around 2 fewer days for patients on placebo.

What are the risks associated with Aimovig?

The most common side effects with Aimovig (which may affect up to 1 in 10 people) are reactions at the site of injection, constipation, muscle spasms and itching.

For the full list of side effects and restrictions of Aimovig, see the package leaflet.

Why is Aimovig authorised in the EU?

Aimovig was shown to be effective at reducing the number of days patients have migraines. Only patients with migraines at least 4 days a month were included in the studies as patients with less frequent migraines are not usually eligible for preventative treatment.

Most of the side effects are mild or moderate in severity. The European Medicines Agency therefore decided that Aimovig’s benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Aimovig?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aimovig have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Aimovig are continuously monitored. Side effects reported with Aimovig are carefully evaluated and any necessary action taken to protect patients.

Other information about Aimovig

Aimovig received a marketing authorisation valid throughout the EU on 26 July 2018.

Name Language First published Last updated
Aimovig : EPAR - Summary for the public BG = bălgarski 2018-08-08  
Aimovig : EPAR - Summary for the public ES = español 2018-08-08  
Aimovig : EPAR - Summary for the public CS = čeština 2018-08-08  
Aimovig : EPAR - Summary for the public DA = dansk 2018-08-08  
Aimovig : EPAR - Summary for the public DE = Deutsch 2018-08-08  
Aimovig : EPAR - Summary for the public ET = eesti keel 2018-08-08  
Aimovig : EPAR - Summary for the public EL = elliniká 2018-08-08  
Aimovig : EPAR - Summary for the public EN = English 2018-08-08  
Aimovig : EPAR - Summary for the public FR = français 2018-08-08  
Aimovig : EPAR - Summary for the public IT = italiano 2018-08-08  
Aimovig : EPAR - Summary for the public LV = latviešu valoda 2018-08-08  
Aimovig : EPAR - Summary for the public LT = lietuvių kalba 2018-08-08  
Aimovig : EPAR - Summary for the public HU = magyar 2018-08-08  
Aimovig : EPAR - Summary for the public MT = Malti 2018-08-08  
Aimovig : EPAR - Summary for the public NL = Nederlands 2018-08-08  
Aimovig : EPAR - Summary for the public PL = polski 2018-08-08  
Aimovig : EPAR - Summary for the public PT = português 2018-08-08  
Aimovig : EPAR - Summary for the public RO = română 2018-08-08  
Aimovig : EPAR - Summary for the public SK = slovenčina 2018-08-08  
Aimovig : EPAR - Summary for the public SL = slovenščina 2018-08-08  
Aimovig : EPAR - Summary for the public FI = suomi 2018-08-08  
Aimovig : EPAR - Summary for the public SV = svenska 2018-08-08  
Aimovig : EPAR - Summary for the public HR = Hrvatski 2018-08-08  
Name Language First published Last updated
Aimovig : EPAR - Risk-management-plan summary (English only) 2018-08-08  

This EPAR was last updated on 08/08/2018 .

Authorisation details

Product details

Product details for Aimovig
NameAimovig
Agency product numberEMEA/H/C/004447
Active substance

erenumab

International non-proprietary name (INN) or common name

erenumab

Therapeutic area Migraine Disorders
Anatomical therapeutic chemical (ATC) code N02CX07
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Aimovig
Marketing-authorisation holder

Novartis Europharm Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union26/07/2018

Contact address:

Novartis Europharm Limited
Vista Building Elm Park
Merrion Road
Dublin 4
Ireland

Product information

Product information

26/07/2018  Aimovig -EMEA/H/C/004447 --

Name Language First published Last updated
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  
Aimovig : EPAR - Product Information EN = English 2018-08-08  

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

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.


Name Language First published Last updated
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  
Aimovig : EPAR - All Authorised presentations EN = English 2018-08-08  

Pharmacotherapeutic group

Analgesics

Therapeutic indication

Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month when initiating treatment with Aimovig.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Aimovig : EPAR - Public assessment report EN = English 2018-08-08  
CHMP summary of positive opinion for Aimovig EN = English 2018-06-01