Nexviadyme

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Avalglucosidase alfa

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

Overview

Nexviadyme is an enzyme replacement therapy used to treat patients with Pompe disease, a rare inherited disorder caused by the lack of an enzyme called alpha-glucosidase. Patients with Pompe disease have a build-up of glycogen (complex sugars) in body tissues, including the heart, lung and skeletal muscles, causing enlarged heart, breathing difficulties and muscle weakness.

Nexviadyme contains the active substance avalglucosidase alfa.

This EPAR was last updated on 02/08/2022

Authorisation details

Product details
Name
Nexviadyme
Agency product number
EMEA/H/C/005501
Active substance
Avalglucosidase alfa
International non-proprietary name (INN) or common name
Avalglucosidase alfa
Therapeutic area (MeSH)
Glycogen Storage Disease Type II
Anatomical therapeutic chemical (ATC) code
A16
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
Genzyme Europe BV
Date of issue of marketing authorisation valid throughout the European Union
24/06/2022
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
Netherlands

Product information

24/06/2022 Nexviadyme - EMEA/H/C/005501 -

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

Other alimentary tract and metabolism products

Therapeutic indication

Nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid α-glucosidase deficiency).

Assessment history

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