Basic Information
V03AB35
sugammadex
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.
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.
Active Substances (1)
sugammadex sodium
Documents (11)
CHMP summary of positive opinion for Sugammadex Mylan
September 17, 2021
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Sugammadex Mylan: EPAR - Procedural steps taken and scientific information after authorisation
March 12, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Sugammadex Mylan
September 17, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Sugammadex Mylan: EPAR - Procedural steps taken and scientific information after authorisation
March 12, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
Sugammadex Mylan : EPAR - Public assessment report
November 22, 2021
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Sugammadex Mylan : EPAR - Risk-management-plan summary
November 22, 2021
RISK_MANAGEMENT_PLAN_SUMMARY
Sugammadex Mylan: EPAR - Procedural steps taken and scientific information after authorisation (archive)
October 3, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
Sugammadex Mylan : EPAR - Public assessment report
November 22, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Sugammadex Mylan : EPAR - Medicine overview
November 22, 2021
OVERVIEW_DOCUMENT
Sugammadex Mylan : EPAR - Product information
November 22, 2021
DRUG_PRODUCT_INFORMATION
Sugammadex Mylan : EPAR - All authorised presentations
November 22, 2021
AUTHORISED_PRESENTATIONS
Overview Q&A (7)
Question
What are the benefits and risks of Sugammadex Mylan?
Answer
Because Sugammadex Mylan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Question
Why is Sugammadex Mylan authorised in the EU?
Answer
The European Medicines Agency concluded that, in accordance with EU requirements, Sugammadex Mylan has been shown to be comparable to Bridion. Therefore, the Agency’s view was that, as for Bridion, the benefits of Sugammadex Mylan outweigh the identified risks and it can be authorised for use in the EU.
Question
What measures are being taken to ensure the safe and effective use of Sugammadex Mylan?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sugammadex Mylan have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Sugammadex Mylan are continuously monitored. Suspected side effects reported with Sugammadex Mylan are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Sugammadex Mylan
Answer
Sugammadex Mylan received a marketing authorisation valid throughout the EU on 15 November 2021.
Question
How has Sugammadex Mylan been studied?
Answer
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Bridion, and do not need to be repeated for Sugammadex Mylan.
As for every medicine, the company provided studies on the quality of Sugammadex Mylan. There was no need for ‘bioequivalence’ studies to investigate whether Sugammadex Mylan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Sugammadex Mylan is given by injection into a vein, so the active substance is delivered straight into the bloodstream.
Question
How is Sugammadex Mylan used?
Answer
Sugammadex Mylan can only be obtained with a prescription. It is given by or under the supervision of an anaesthetist (a doctor specialised in anaesthesia). Sugammadex Mylan is given into a vein as a single ‘bolus’ injection (given all at once).
For more information about using Sugammadex Mylan, see the package leaflet or contact your doctor or pharmacist.
Question
How does Sugammadex Mylan work?
Answer
The active substance in Sugammadex Mylan, sugammadex, attaches to the muscle relaxants rocuronium and vecuronium forming , stopping them from having an effect. As a result, the muscles contract and begin to work normally again, including the muscles that help the patient to breathe.