Sugammadex Amomed

Authorised

This medicine is authorised for use in the European Union

sugammadex

Overview

Sugammadex Amomed 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 Amomed is used to speed up the recovery from the muscle relaxant, usually at the end of the operation.

Sugammadex Amomed can be used in adults who have received rocuronium and vecuronium, and in children from birth who have received rocuronium.

Sugammadex Amomed contains the active substance sugammadex and is a ‘generic medicine’. This means that Sugammadex Amomed contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Sugammadex Amomed is Bridion.

How is Sugammadex Amomed used?

Sugammadex Amomed can only be obtained with a prescription. It is given by or under the supervision of an anaesthetist (a doctor specialised in anaesthesia). Sugammadex Amomed is given into a vein as a single bolus injection (given all at once).

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

How does Sugammadex Amomed work?

The active substance in Sugammadex Amomed, sugammadex, attaches to the muscle relaxants rocuronium and vecuronium 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.

How has Sugammadex Amomed 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 Amomed.

As for every medicine, the company provided data on the quality of Sugammadex Amomed. There was no need for ‘bioequivalence’ studies to investigate whether Sugammadex Amomed is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Sugammadex Amomed 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 Amomed?

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

Why is Sugammadex Amomed authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Sugammadex Amomed has been shown to be comparable to Bridion. Therefore, the Agency’s view was that, as for Bridion, the benefits of Sugammadex Amomed 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 Amomed?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sugammadex Amomed have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Sugammadex Amomed are continuously monitored. Suspected side effects reported with Sugammadex Amomed are carefully evaluated and any necessary action taken to protect patients.

Other information about Sugammadex Amomed

Sugammadex Amomed received a marketing authorisation valid throughout the EU on 10 January 2023.

Sugammadex Amomed : EPAR - Medicine overview

Reference Number: EMADOC-1829012207-25025

Sugammadex Amomed : EPAR - Risk Management Plan

Product information

Sugammadex Amomed : EPAR - Product information

Sugammadex Amomed : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Sugammadex Amomed
• 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.

For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in paediatric patients from birth to 17 years.

Authorisation details

• EMA product number:
  EMEA/H/C/005935
• 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:
  AOP Orphan Pharmaceuticals GmbH

  Leopold-Ungar-Platz 2; 1190 Vienna; Austria

• Opinion adopted:
  10/11/2022
• Marketing authorisation issued:
  10/01/2023
• Revision:
  5

Assessment history

Changes since initial authorisation of medicine

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

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

Initial marketing authorisation documents

Sugammadex Amomed : EPAR - Public assessment report

Reference Number: EMA/CHMP/906354/2022

CHMP summary of positive opinion for Sugammadex Amomed

Reference Number: EMA/CHMP/855683/2022