Sugammadex Mylan

Authorised

This medicine is authorised for use in the European Union

sugammadex

Overview

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.

How is Sugammadex Mylan used?

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). The dose depends on the patient’s age and body weight and on how much the muscle relaxant is affecting the muscles.

Sugammadex Mylan is not recommended for use in children and adolescents for recovery after vecuronium, or for rapid recovery after any muscle relaxant.

For more information about using Sugammadex Mylan, see the package leaflet or contact your doctor or pharmacist.

How does Sugammadex Mylan work?

The active substance in Sugammadex Mylan, 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 effect of blockade of the muscles due to rocuronium and vecuronium on the muscles is reversed, and the muscles begin to work normally again, including the muscles that help the patient to breathe.

How has Sugammadex Mylan been studied?

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.

What are the benefits and risks of Sugammadex Mylan?

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

Why is Sugammadex Mylan authorised in the EU?

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.

What measures are being taken to ensure the safe and effective use of Sugammadex Mylan?

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.

Other information about Sugammadex Mylan

Sugammadex Mylan received a marketing authorisation valid throughout the EU on 15 November 2021.

Sugammadex Mylan : EPAR - Medicine overview

Reference Number: EMA/535318/2021

Sugammadex Mylan : EPAR - Risk-management-plan summary

Product information

Sugammadex Mylan : EPAR - Product information

Sugammadex Mylan : EPAR - All authorised presentations

Product details

• Name of medicine:
  Sugammadex Mylan
• 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/005403
• 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:
  Mylan Pharmaceuticals Limited

  Damastown Industrial Park,; Mulhuddart, Dublin 15,; DUBLIN; Ireland

• Opinion adopted:
  16/09/2021
• Marketing authorisation issued:
  15/11/2021
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

Sugammadex Mylan: EPAR - Procedural steps taken and scientific information after authorisation

Sugammadex Mylan: EPAR - Procedural steps taken and scientific information after authorisation (archive)

Initial marketing authorisation documents

Sugammadex Mylan : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/555625/2021

CHMP summary of positive opinion for Sugammadex Mylan

AdoptedReference Number: EMA/CHMP/493758/2021