| Product No | EMEA/H/C/003853 |
|---|---|
| Brand Name | Ibrance |
| Nonproprietary Name | palbociclib |
| API | palbociclib |
| ATC Code | L01XE33 |
| Indications | Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer:in combination with an aromatase inhibitor;in combination with fulvestrant in women who have received prior endocrine therapy.In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist. |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Pfizer Europe MA EEIG? |
| Status | Authorised(授权) |
| Authorization Date | 2016-11-09 |
| Version | 14 |
| 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