Sugammadex Amomed (sugammadex)
Generic
- Region
- 🇪🇺 EU
- Active substance
- sugammadex
- Company
- AOP Orphan Pharmaceuticals GmbH
- Status
- Authorised
- Therapeutic area
- Neuromuscular Blockade
- CHMP opinion
- Thu 10 Nov 2022
- EU approval
- Tue 10 Jan 2023
- Designations
- Generic
- Application
- EMEA/H/C/005935
- ATC
- V03AB35
- Official record
- www.ema.europa.eu
Indication
Reversal of neuromuscular blockade induced by rocuronium or vecuronium. For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in paediatric patients from birth to 17 years.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Sugammadex Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Sugammadex Adroiq Authorised · Extrovis EU Ltd
- 🇪🇺 Bridion Authorised · Merck Sharp & Dohme B.V.
- 🇪🇺 Sugammadex Piramal Authorised · Piramal Critical Care B.V.
- 🇪🇺 Sugammadex Fresenius Kabi Authorised · Fresenius Kabi Deutschland GmbH
- 🇪🇺 Sugammadex Lorien Application withdrawn · LABORATORIOS LORIEN, S.L
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.