Overview

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.

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.

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.

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.

Because Sugammadex Fresenius Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.

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.

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.

Sugammadex Fresenius Kabi received a marketing authorisation valid throughout the EU on 15 July 2022.

Sugammadex Fresenius Kabi : EPAR - Medicine overview

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Sugammadex Fresenius Kabi : EPAR - Risk management plan summary

Product information

Sugammadex Fresenius Kabi : EPAR - Product Information

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15/07/2022

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Sugammadex Fresenius Kabi : EPAR - All Authorised Presentations

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Product details

Name of medicine
Sugammadex Fresenius Kabi
Active substance
sugammadex sodium
International non-proprietary name (INN) or common name
sugammadex
Therapeutic area (MeSH)
Neuromuscular Blockade
Anatomical therapeutic chemical (ATC) code
V03AB35

Pharmacotherapeutic group

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.

Authorisation details

EMA product number
EMEA/H/C/005760

Generic

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.

Marketing authorisation holder
Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1,
61352 Bad Homburg v.d.Höhe
Germany

Opinion adopted
19/05/2022
Marketing authorisation issued
15/07/2022

Assessment history

Sugammadex Fresenius Kabi : EPAR - Public Assessment Report

CHMP summary of positive opinion for Sugammadex Fresenius Kabi

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