Sugammadex Piramal
sugammadex
Table of contents
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.
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List item
Sugammadex Piramal : EPAR - Medicine Overview (PDF/142.74 KB)
Adopted
First published: 18/07/2023
EMA/207906/2023 -
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List item
Sugammadex Piramal : EPAR - Risk management plan summary (PDF/528.41 KB)
First published: 18/07/2023
Authorisation details
Product details | |
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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 | |
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Marketing-authorisation holder |
Piramal Critical Care B.V.
|
Date of issue of marketing authorisation valid throughout the European Union |
23/06/2023
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Contact address |
Rouboslaan 32 |
Product information
23/06/2023 Sugammadex Piramal - EMEA/H/C/006083 -
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.
Pharmacotherapeutic group
Therapeutic indication
Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.