Sugammadex Mylan (sugammadex)
Generic
- Region
- 🇪🇺 EU
- Active substance
- sugammadex
- Company
- Mylan Pharmaceuticals Limited
- Status
- Authorised
- Therapeutic area
- Neuromuscular Blockade
- CHMP opinion
- Thu 16 Sep 2021
- EU approval
- Mon 15 Nov 2021
- Designations
- Generic
- Application
- EMEA/H/C/005403
- ATC
- V03AB35
- Official record
- www.ema.europa.eu
Indication
Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults. For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Sugammadex Amomed Authorised · AOP Orphan Pharmaceuticals GmbH
- 🇪🇺 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- 🇪🇺 Sugammadex Lorien Application withdrawn · LABORATORIOS LORIEN, S.L
Follow Sugammadex Mylan
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.