Sugammadex Piramal (sugammadex)
Generic
- Region
- 🇪🇺 EU
- Active substance
- sugammadex
- Company
- Piramal Critical Care B.V.
- Status
- Authorised
- Therapeutic area
- Neuromuscular Blockade
- CHMP opinion
- Wed 26 Apr 2023
- EU approval
- Fri 23 Jun 2023
- Designations
- Generic
- Application
- EMEA/H/C/006083
- 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 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 Amomed Authorised · AOP Orphan Pharmaceuticals GmbH
- 🇪🇺 Sugammadex Adroiq Authorised · Extrovis EU Ltd
- 🇪🇺 Bridion Authorised · Merck Sharp & Dohme 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- 🇪🇺 Sugammadex Lorien Application withdrawn · LABORATORIOS LORIEN, S.L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.