Overview

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.

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 either a single injection of 140 mg or 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.

A chemical messenger called CGRP has been shown to be involved in the development of migraine. The active substance in Aimovig, erenumab, 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.

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.

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.

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.

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.

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

Aimovig : EPAR - Summary for the public

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Aimovig : EPAR - Risk-management-plan summary

Product information

Aimovig : EPAR - Product Information

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Latest procedure affecting product information: IAIN/0029/G

10/08/2023

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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).

Aimovig : EPAR - All Authorised presentations

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Product details

Name of medicine
Aimovig
Active substance
erenumab
International non-proprietary name (INN) or common name
erenumab
Therapeutic area (MeSH)
Migraine Disorders
Anatomical therapeutic chemical (ATC) code
N02CD01

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.

Authorisation details

EMA product number
EMEA/H/C/004447

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.

Marketing authorisation holder
Novartis Europharm Limited

Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Opinion adopted
01/06/2018
Marketing authorisation issued
26/07/2018
Revision
11

Assessment history

Aimovig : EPAR - Procedural steps taken and scientific information after authorisation

Aimovig-H-C-PSUSA-00010699-201911 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Aimovig-H-C-PSUSA-00010699-201905 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Aimovig-H-C-PSUSA-00010699-201811 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Aimovig-H-C-4447-X-0001 : EPAR - Assessment report

Aimovig : EPAR - Public assessment report

CHMP summary of positive opinion for Aimovig

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