Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
Overview Summary
Comprehensive product overview and regulatory summary
Sugammadex Piramal 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 Piramal is used to speed up the recovery from the muscle relaxant, usually at the end of the operation.
Sugammadex Piramal can be used in adults who have received rocuronium and vecuronium, and in children aged 2 years or older who have received rocuronium.
Sugammadex Piramal is a ‘generic medicine’. This means that Sugammadex Piramal 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 Piramal is Bridion.
Sugammadex Piramal contains the active substance sugammadex.
Active Substances (1)
sugammadex sodium
Documents (10)
CHMP summary of positive opinion for Sugammadex Piramal
April 26, 2023
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Sugammadex Piramal : EPAR - Product Information
July 18, 2023
DRUG_PRODUCT_INFORMATION
Sugammadex Piramal : EPAR - Public Assessment Report
July 18, 2023
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Sugammadex Piramal : EPAR - Risk management plan summary
July 18, 2023
RISK_MANAGEMENT_PLAN_SUMMARY
Sugammadex Piramal: EPAR - Procedural steps taken and scientific information after authorisation
April 14, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
Sugammadex Piramal : EPAR - Medicine Overview
July 18, 2023
OVERVIEW_DOCUMENT
Sugammadex Piramal : EPAR - All authorised presentations
July 18, 2023
AUTHORISED_PRESENTATIONS
Sugammadex Piramal: EPAR - Procedural steps taken and scientific information after authorisation (archive)
February 26, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
Sugammadex Piramal : EPAR - Public Assessment Report
July 18, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Sugammadex Piramal
April 26, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (7)
Question
What are the benefits and risks of Sugammadex Piramal?
Answer
Because Sugammadex Piramal is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.
For the list of side effects and restrictions with Sugammadex Piramal, see the package leaflet.
Question
How is Sugammadex Piramal used?
Answer
The medicine can only be obtained with a prescription. It is given by or under the supervision of an anaesthetist (a doctor specialised in anaesthesia). Sugammadex Piramal is given into a vein as a single bolus injection (given all at once).
For more information about using Sugammadex Piramal, see the package leaflet or contact your doctor or pharmacist.
Question
How does Sugammadex Piramal work?
Answer
The active substance in Sugammadex Piramal, 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.
Question
Why is Sugammadex Piramal authorised in the EU?
Answer
The European Medicines Agency concluded that, in accordance with EU requirements, Sugammadex Piramal has been shown to be comparable to Bridion. Therefore, the Agency’s view was that, as for Bridion, the benefits of Sugammadex Piramal 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 Piramal?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sugammadex Piramal have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Sugammadex Piramal are continuously monitored. Suspected side effects reported with Sugammadex Piramal are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Sugammadex Piramal
Answer
Sugammadex Piramal received a marketing authorisation valid throughout the EU on 23 June 2023.
Question
How has Sugammadex Piramal been studied?
Answer
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Bridion, and do not need to be repeated for Sugammadex Piramal.
As for every medicine, the company provided studies on the quality of Sugammadex Piramal. There was no need for ‘bioequivalence’ studies to investigate whether Sugammadex Piramal is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Sugammadex Piramal is given by injection into a vein, so the active substance is delivered straight into the bloodstream.