Sugammadex Piramal

sugammadex

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

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.

: 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.

: 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.

: 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.

: 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.

: 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.

: 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.

: Sugammadex Piramal received a marketing authorisation valid throughout the EU on 23 June 2023.

List item

Sugammadex Piramal : EPAR - Medicine Overview (PDF/142.74 KB)

Adopted

First published: 18/07/2023
EMA/207906/2023
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Sugammadex Piramal : EPAR - Risk management plan summary (PDF/528.41 KB)

First published: 18/07/2023

This EPAR was last updated on 18/07/2023

Authorisation details

Product details
Name	Sugammadex Piramal
Agency product number	EMEA/H/C/006083
Active substance	sugammadex sodium
International non-proprietary name (INN) or common name	sugammadex
Therapeutic area (MeSH)	Neuromuscular Blockade
Anatomical therapeutic chemical (ATC) code	V03AB35
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.

Publication details
Marketing-authorisation holder	Piramal Critical Care B.V.
Date of issue of marketing authorisation valid throughout the European Union	23/06/2023
Contact address	Rouboslaan 32 2252 TR Voorschoten Netehrlands

Product information

23/06/2023 Sugammadex Piramal - EMEA/H/C/006083 -

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Sugammadex Piramal : EPAR - Product Information (PDF/398.33 KB)

First published: 18/07/2023
- Bulgarian
  (PDF/362.76 KB)
- Croatian
  (PDF/479.81 KB)
- Czech
  (PDF/485.18 KB)
- Danish
  (PDF/420.84 KB)
- Dutch
  (PDF/419 KB)
- Estonian
  (PDF/398.84 KB)
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  (PDF/406.04 KB)
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  (PDF/410.85 KB)
- Italian
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- Latvian
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- Maltese
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  (PDF/496.86 KB)
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- Romanian
  (PDF/522.27 KB)
- Slovak
  (PDF/492.74 KB)
- Slovenian
  (PDF/513.82 KB)
- Spanish
  (PDF/396.42 KB)
- Swedish
  (PDF/405.83 KB)

Other EU languages available icon 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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

List item

Sugammadex Piramal : EPAR - All authorised presentations (PDF/23.64 KB)

First published: 18/07/2023
- Bulgarian
  (PDF/46.89 KB)
- Croatian
  (PDF/43.28 KB)
- Czech
  (PDF/48.02 KB)
- Danish
  (PDF/21.73 KB)
- Dutch
  (PDF/23.17 KB)
- Estonian
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- Finnish
  (PDF/23.18 KB)
- French
  (PDF/23.64 KB)
- German
  (PDF/22.9 KB)
- Greek
  (PDF/46.04 KB)
- Hungarian
  (PDF/33.07 KB)
- Icelandic
  (PDF/24.74 KB)
- Italian
  (PDF/23.64 KB)
- Latvian
  (PDF/46.23 KB)
- Lithuanian
  (PDF/43.49 KB)
- Maltese
  (PDF/43.39 KB)
- Norwegian
  (PDF/24.01 KB)
- Polish
  (PDF/46.57 KB)
- Portuguese
  (PDF/24.94 KB)
- Romanian
  (PDF/45.51 KB)
- Slovak
  (PDF/45.68 KB)
- Slovenian
  (PDF/32.43 KB)
- Spanish
  (PDF/23.84 KB)
- Swedish
  (PDF/24.24 KB)

Pharmacotherapeutic group

sugammadex

Therapeutic indication

Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.

Assessment history

Initial marketing-authorisation documents

News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 2023

26/04/2023

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Sugammadex Piramal

Table of contents

Overview