On 30 March 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Sugammadex Adroiq, intended to reverse the effects of the muscle relaxants rocuronium and vecuronium. The applicant for this medicinal product is Extrovis EU Ltd.
Sugammadex Adroiq will be available as a 100 mg/ml solution for injection. The active substance of Sugammadex Adroiq is sugammadex, an antidote (ATC code: V03AB35). Sugammadex is a selective relaxant-binding agent which forms a complex with the muscle relaxants rocuronium and vecuronium, thereby reversing their neuromuscular blockade effect and allowing muscles to function normally again.
Sugammadex Adroiq is a generic of Bridion, which has been authorised in the EU since 25 July 2008. Studies have demonstrated the satisfactory quality of Sugammadex Adroiq. Since Sugammadex Adroiq is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product Bridion was not required. A question and answer document on generic medicines can be found here.
The full indication is:
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.
Sugammadex Adroiq should only be administered by, or under the supervision of, an anaesthetist.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
|Agency product number||
|International non-proprietary name (INN) or common name||
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.
|Date opinion adopted||