اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BAVENCIO از شرکت EMD SERONO INC
Biologic License Application (BLA): 761049
Company: EMD SERONO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BAVENCIO | AVELUMAB | 20MG/ML | INJECTABLE;INJECTION | Prescription |
None |
No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/23/2017 | ORIG-1 | Approval |
N/A; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/30/2020 | SUPPL-9 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761049Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761049Orig1s009.pdf |
||
| 05/14/2019 | SUPPL-6 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761049s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761049Orig1s006ltr.pdf |
||
| 11/10/2020 | SUPPL-5 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761049Orig1s005ltr.pdf |
||
| 10/19/2018 | SUPPL-3 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761049s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761049Orig1s003ltr.pdf |
||
| 10/12/2017 | SUPPL-2 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s002ltr.pdf |
||
| 04/25/2017 | SUPPL-1 | Supplement |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/10/2020 | SUPPL-5 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s005lbl.pdf | |
| 11/10/2020 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s005lbl.pdf | |
| 06/30/2020 | SUPPL-9 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s009lbl.pdf | |
| 05/14/2019 | SUPPL-6 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761049s006lbl.pdf | |
| 10/19/2018 | SUPPL-3 |
Efficacy-New Dosing Regimen |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761049s003lbl.pdf | |
| 10/12/2017 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s002lbl.pdf | |
| 03/23/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s000lbl.pdf |
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