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 Fresenius Kabi 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 Fresenius Kabi is used to speed up the recovery from the muscle relaxant, usually at the end of the operation.
Sugammadex Fresenius Kabi can be used in adults who have received rocuronium and vecuronium, and in children aged 2 years or older who have received rocuronium.
Sugammadex Fresenius Kabi contains the active substance sugammadex and is a ‘generic medicine’. This means that Sugammadex Fresenius Kabi contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Bridion. For more information on generic medicines, see the question-and-answer document here.
Active Substances (1)
sugammadex sodium
Documents (7)
CHMP summary of positive opinion for Sugammadex Fresenius Kabi
May 20, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
Sugammadex Fresenius Kabi : EPAR - Public Assessment Report
July 21, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
Sugammadex Fresenius Kabi : EPAR - Product Information
July 21, 2022
DRUG_PRODUCT_INFORMATION
Sugammadex Fresenius Kabi : EPAR - Procedural steps taken and scientific information after the authorisation
March 25, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
Sugammadex Fresenius Kabi : EPAR - Risk management plan summary
July 21, 2022
RISK_MANAGEMENT_PLAN_SUMMARY
Sugammadex Fresenius Kabi : EPAR - All Authorised Presentations
July 21, 2022
AUTHORISED_PRESENTATIONS
Sugammadex Fresenius Kabi : EPAR - Medicine overview
July 21, 2022
OVERVIEW_DOCUMENT
Overview Q&A (7)
Question
How is Sugammadex Fresenius Kabi used?
Answer
Sugammadex Fresenius Kabi can only be obtained with a prescription. It is given by or under the supervision of an anaesthetist (a doctor specialised in anaesthesia). Sugammadex Fresenius Kabi is given into a vein as a single ‘bolus’ injection (given all at once). The dose depends on the patient’s body weight and on how much the muscle relaxant is affecting the muscles.
For more information about using Sugammadex Fresenius Kabi, see the package leaflet or contact your doctor or pharmacist.
Question
How does Sugammadex Fresenius Kabi work?
Answer
The active substance in Sugammadex Fresenius Kabi, sugammadex, is a ‘selective relaxant binding agent’. This means that it attaches to the muscle relaxants rocuronium and vecuronium forming a ‘complex’ that inactivates the muscle relaxants and stops them having an effect. As a result, the muscles contract and begin to work normally again, including the muscles that help the patient to breathe.
Question
Why is Sugammadex Fresenius Kabi authorised in the EU?
Answer
The European Medicines Agency concluded that, in accordance with EU requirements, Sugammadex Fresenius Kabi has been shown to be comparable to Bridion. Therefore, the Agency’s view was that, as for Bridion, the benefits of Sugammadex Fresenius Kabi 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 Fresenius Kabi?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sugammadex Fresenius Kabi have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Sugammadex Fresenius Kabi are continuously monitored. Suspected side effects reported with Sugammadex Fresenius Kabi are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Sugammadex Fresenius Kabi
Answer
Sugammadex Fresenius Kabi received a marketing authorisation valid throughout the EU on 15 July 2022.
Question
What are the benefits and risks of Sugammadex Fresenius Kabi?
Answer
Because Sugammadex Fresenius Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Question
How has Sugammadex Fresenius Kabi 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 Fresenius Kabi.
As for every medicine, the company provided data on the quality of Sugammadex Fresenius Kabi. There was no need for ‘bioequivalence’ studies to investigate whether Sugammadex Fresenius Kabi is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Sugammadex Fresenius Kabi is given by injection into a vein, so the active substance is delivered straight into the bloodstream.