Basic Information
Sugammadex Mylan
Regulatory Information
EMEA/H/C/005403
November 15, 2021
September 16, 2021
6
March 12, 2025
Company Information
Ireland
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN
MYLAN PHARMACEUTICALS PRIVATE LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.