Bridion

RSS

sugammadex

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Bridion. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Bridion.

This EPAR was last updated on 05/11/2018

Authorisation details

Product details
Name
Bridion
Agency product number
EMEA/H/C/000885
Active substance
sugammadex
International non-proprietary name (INN) or common name
sugammadex
Therapeutic area (MeSH)
Neuromuscular Blockade
Anatomical therapeutic chemical (ATC) code
V03AB35
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
25/07/2008
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

30/07/2018 Bridion - EMEA/H/C/000885 - T/0030

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ALL OTHER THERAPEUTIC PRODUCTS

Therapeutic indication

Reversal of neuromuscular blockade induced by rocuronium or vecuronium.

For the peadiatric population: sugammadex is only recommended for routine reversal of rocuronium-induced blockade in children and adolescents.

Assessment history

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