| Product No | EMEA/H/C/004069 |
|---|---|
| Brand Name | Palonosetron Hospira |
| Nonproprietary Name | palonosetron |
| API | palonosetron hydrochloride |
| ATC Code | A04AA05 |
| Indications | Palonosetron Hospira 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 Hospira 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. |
| Orphan Drug | no |
| Generics | yes |
| Marketing Authorization Holder | Pfizer Europe MA EEIG |
| Status | Withdrawn |
| Authorization Date | 2016-04-08 |
| Version | 4 |
| Condition Approval | no |
| Exceptions | no |
| Biosimilar | no |
| Details | 查看 (公众评估报告、授权细节、产品规格/剂型、标签、历史评估信息) |
Extended Information