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ACTIVE SUBSTANCE / INN

SUGAMMADEX

Brand name(s): Sugammadex Piramal, Bridion, Sugammadex Fresenius Kabi, Sugammadex Adroiq, Sugammadex Amomed, Sugammadex Mylan, SUGAMMADEX
FDA LISTED
EMA LISTED
AUTHORISED
NONE (TENTATIVE APPROVAL)
Neuromuscular Blockade
ANDA213915
ACTIVE SUBSTANCE
Sugammadex
REGULATORS
FDA · EMA
SPONSORS / MAH
Extrovis EU Ltd, Mylan Pharmaceuticals Limited, Merck Sharp & Dohme B.V.
TOTAL APPLICATIONS
7
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SUGAMMADEXANDA213915MYLAN PHARMS INCNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Sugammadex AmomedAOP Orphan Pharmaceuticals GmbHAuthorised10/01/2023Neuromuscular Blockade
Sugammadex AdroiqExtrovis EU LtdAuthorised26/05/2023Neuromuscular Blockade
BridionMerck Sharp & Dohme B.V.Authorised25/07/2008Neuromuscular Blockade
Sugammadex PiramalPiramal Critical Care B.V.Authorised23/06/2023Neuromuscular Blockade
Sugammadex MylanMylan Pharmaceuticals LimitedAuthorised15/11/2021Neuromuscular Blockade
Sugammadex Fresenius KabiFresenius Kabi Deutschland GmbHAuthorised15/07/2022Neuromuscular Blockade

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