Overview

Ajovy is a medicine used to prevent migraine in adults who have migraines at least 4 days a month. The active substance contained in Ajovy is fremanezumab.

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

The recommended dose is either 225 mg every month or 675 mg every three months. For the 675 mg dose, three injections of 225 mg have to be injected one after another, each in a different place.

Ajovy 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 Ajovy, see the package leaflet or contact your doctor or pharmacist.

A chemical messenger called CGRP contributes to the development of migraine. Ajovy is a monoclonal antibody (a type of protein) designed to attach to CGRP and prevent it from binding to its target on the body’s cells thereby helping to prevent migraines from occurring.

Ajovy was shown to reduce the number of days patients have moderate to severe headaches and migraines in 2 main studies.

In a study of 1,130 patients who had moderate to severe headaches 13 days a month on average, those treated with Ajovy had between 4 and 5 fewer days with moderate to severe headaches per month compared with 2 to 3 fewer days for patients on placebo (a dummy treatment), during the 12 week-study.

In a study with 875 patients who had migraines 9 days a month on average, those treated with Ajovy had between 3 and 4 fewer days with migraines per month compared with around 2 fewer days for patients on placebo, during the 12 week-study.

The most common side effects with Ajovy (which may affect more than 1 in 10 people) are reactions at the site of injection: pain, hardening (induration) and reddening of the skin (erythema).

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

Ajovy can reduce the number of days patients have moderate to severe headaches and migraines. As most of the side effects are manageable and mild or moderate in severity, the European Medicines Agency decided that Ajovy’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 Ajovy have been included in the summary of product characteristics and the package leaflet.

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

Ajovy received a marketing authorisation valid throughout the EU on 28/03/2019.

Ajovy : EPAR - Medicine overview

Ajovy : EPAR - Risk-management-plan summary

Product information

Ajovy : EPAR - Product Information

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română (RO) (1.29 MB - PDF)
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Suomi (FI) (1.07 MB - PDF)
svenska (SV) (1.09 MB - PDF)

Latest procedure affecting product information: R/0044

06/11/2023

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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).

Ajovy : EPAR - All Authorised presentations

български (BG) (36.85 KB - PDF)
español (ES) (12.41 KB - PDF)
čeština (CS) (35.01 KB - PDF)
dansk (DA) (12.5 KB - PDF)
Deutsch (DE) (12.37 KB - PDF)
eesti keel (ET) (15.46 KB - PDF)
ελληνικά (EL) (36.07 KB - PDF)
français (FR) (12.49 KB - PDF)
hrvatski (HR) (21.35 KB - PDF)
íslenska (IS) (12.4 KB - PDF)
italiano (IT) (16.25 KB - PDF)
latviešu valoda (LV) (36.5 KB - PDF)
lietuvių kalba (LT) (22.19 KB - PDF)
magyar (HU) (30.39 KB - PDF)
Malti (MT) (34.18 KB - PDF)
Nederlands (NL) (12.3 KB - PDF)
norsk (NO) (12.55 KB - PDF)
polski (PL) (34.55 KB - PDF)
português (PT) (12.81 KB - PDF)
română (RO) (34.52 KB - PDF)
slovenčina (SK) (32.61 KB - PDF)
slovenščina (SL) (21.38 KB - PDF)
Suomi (FI) (12.26 KB - PDF)
svenska (SV) (12.56 KB - PDF)

Product details

Name of medicine
Ajovy
Active substance
fremanezumab
International non-proprietary name (INN) or common name
fremanezumab
Therapeutic area (MeSH)
Migraine Disorders
Anatomical therapeutic chemical (ATC) code
N02CD03

Pharmacotherapeutic group

Calcitonin gene-related peptide (CGRP) antagonists

Therapeutic indication

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

Authorisation details

EMA product number
EMEA/H/C/004833
Marketing authorisation holder
Teva GmbH

Graf-Arco-Straße 3
D-89079 Ulm
Germany

Opinion adopted
31/01/2019
Marketing authorisation issued
28/03/2019
Revision
10

Assessment history

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

Ajovy-H-C-PSUSA-00010758-202103 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Ajovy- H-C-PSUSA-00010758-202003: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Ajovy : EPAR - Public assessment report

CHMP summary of positive opinion for Ajovy

Topics

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