Basic Information
Sugammadex Amomed
Regulatory Information
EMEA/H/C/005935
January 10, 2023
November 10, 2022
3
September 23, 2024
Company Information
Austria
Leopold-Ungar-Platz 2 1190 Vienna
AOP Orphan Pharmaceuticals GmbH
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication 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.
Overview Summary
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](https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-generic-medicines_en.pdf).