Sugammadex Amomed 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 Amomed is used to speed up the recovery from the muscle relaxant, usually at the end of the operation.
Sugammadex Amomed can be used in adults who have received rocuronium and vecuronium, and in children aged 2 years or older who have received rocuronium.
Sugammadex Amomed contains the active substance sugammadex and is a ‘generic medicine’. This means that Sugammadex Amomed contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Sugammadex Amomed is called Bridion. For more information on generic medicines, see the question-and-answer document here.
Sugammadex Amomed : EPAR - Medicine overview (PDF/143.46 KB)
First published: 13/01/2023
Sugammadex Amomed : EPAR - Risk-Management-Plan summary (PDF/140.18 KB)
First published: 13/01/2023
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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.
AOP Orphan Pharmaceuticals GmbH
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06/07/2023 Sugammadex Amomed - EMEA/H/C/005935 - IB/0001
This medicine’s product information is available in all official EU languages.
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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.
All other therapeutic products
Reversal of neuromuscular blockade induced by rocuronium or vecuronium.
For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.