Palonosetron Accord (palonosetron)
- Region
- 🇪🇺 EU
- Active substance
- palonosetron
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Vomiting; Nausea; Cancer
- CHMP opinion
- Thu 31 Mar 2016
- EU approval
- Thu 26 May 2016
- Designations
- Generic
- Application
- EMEA/H/C/004129
- ATC
- A04AA05
- Official record
- www.ema.europa.eu
Indication
Palonosetron Accord is indicated in adults for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Palonosetron Accord is indicated in paediatric patients 1 month of age and older for: The prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Akynzeo Authorised · Helsinn Birex Pharmaceuticals Ltd
- 🇪🇺 Aloxi Authorised · Helsinn Birex Pharmaceuticals Ltd.
- 🇪🇺 Palonosetron Hospira Withdrawn · Pfizer Europe MA EEIG
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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.