Aloxi (palonosetron)
- Region
- 🇪🇺 EU
- Active substance
- palonosetron
- Company
- Helsinn Birex Pharmaceuticals Ltd.
- Status
- Authorised
- Therapeutic area
- Vomiting; Cancer
- EU approval
- Tue 22 Mar 2005
- Application
- EMEA/H/C/000563
- ATC
- A04AA05
- Official record
- www.ema.europa.eu
Indication
Aloxi 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. Aloxi 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
- 🇪🇺 Palonosetron Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Palonosetron Hospira Withdrawn · Pfizer Europe MA EEIG
Follow Aloxi
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.