Sugammadex Mylan
sugammadex
Table of contents
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.
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Sugammadex Mylan : EPAR - Medicine overview (PDF/143.16 KB)
First published: 22/11/2021
EMA/535318/2021 -
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Sugammadex Mylan : EPAR - Risk-management-plan summary (PDF/82.72 KB)
First published: 22/11/2021
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
|
Generic |
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 | |
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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 |
Product information
02/06/2021 Sugammadex Mylan - EMEA/H/C/005403 - IB/0001
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).
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.