Sugammadex Mylan

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sugammadex

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

Overview

Sugammadex Mylan is a medicine used to reverse the effect of the muscle relaxants rocuronium and vecuronium. Muscle relaxants are medicines used during some types of operation to make the muscles relax, including the muscles that help the patient to breathe. Muscle relaxants make it easier for the surgeon to do the operation. Sugammadex Mylan is used to speed up the recovery from the muscle relaxant, usually at the end of the operation.

Sugammadex Mylan can be used in adults who have received rocuronium and vecuronium, and in children aged 2 years or older who have received rocuronium.

Sugammadex Mylan contains the active substance sugammadex and is a ‘generic medicine’. This means that Sugammadex Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Bridion.

This EPAR was last updated on 03/10/2022

Authorisation details

Product details
Name
Sugammadex Mylan
Agency product number
EMEA/H/C/005403
Active substance
sugammadex sodium
International non-proprietary name (INN) or common name
sugammadex
Therapeutic area (MeSH)
Neuromuscular Blockade
Anatomical therapeutic chemical (ATC) code
V03AB35
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Mylan Ireland Limited
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
15/11/2021
Contact address

Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland

Product information

02/06/2021 Sugammadex Mylan - EMEA/H/C/005403 - IB/0001

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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

All other therapeutic products

Therapeutic indication

Reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults.

For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Assessment history

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