Vydura

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rimegepant

Authorised
This medicine is authorised for use in the European Union.

Overview

Vydura is a medicine used to treat migraine with or without aura (unusual visual or other sensory experiences) in adults. It is also used to prevent migraine in adults who have at least 4 migraines attacks a month.

Vydura contains the active substance rimegepant.

This EPAR was last updated on 05/06/2023

Authorisation details

Product details
Name
Vydura
Agency product number
EMEA/H/C/005725
Active substance
Rimegepant
International non-proprietary name (INN) or common name
rimegepant
Therapeutic area (MeSH)
Migraine Disorders
Anatomical therapeutic chemical (ATC) code
N02CD06
Additional monitoringAdditional 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
Pfizer Europe MA EEIG 
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
25/04/2022
Contact address

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

02/06/2023 Vydura - EMEA/H/C/005725 - IB/0011

Other EU languages available icon 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:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antimigraine preparations, calcitonin gene-related peptide (CGRP) antagonists

Therapeutic indication

Vydura is indicated for the

  • Acute treatment of migraine with or without aura in adults;
  • Preventative treatment of episodic migraine in adults who have at least 4 migraine attacks per month.

Assessment history

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