| Product No | EMEA/H/C/000089 |
|---|---|
| Brand Name | Caelyx pegylated liposomal |
| Nonproprietary Name | doxorubicin |
| API | doxorubicin hydrochloride |
| ATC Code | L01DB |
| Indications | Caelyx pegylated liposomal is indicated:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk;for treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen;in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant;for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts ( |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Baxter Holding B.V. |
| Status | Authorised(授权) |
| Authorization Date | 1996-06-20 |
| Version | 35 |
| 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