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
AIMOVIG از شرکت AMGEN INC
Biologic License Application (BLA): 761077
Company: AMGEN INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AIMOVIG | ERENUMAB-AOOE | 70MG/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 |
|---|---|---|---|---|---|---|---|
| 05/17/2018 | ORIG-1 | Approval |
N/A |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761077s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/11/2021 | SUPPL-11 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761077s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761077Orig1s011ltr.pdf |
||
| 02/03/2021 | SUPPL-9 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761077s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761077Orig1s009ltr.pdf |
||
| 04/30/2020 | SUPPL-7 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761077s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761077Orig1s007ltr.pdf |
||
| 02/15/2020 | SUPPL-4 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761077s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761077Orig1s004ltr.pdf |
||
| 10/04/2019 | SUPPL-3 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761077s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761077Orig1s003ltr.pdf |
||
| 03/11/2019 | SUPPL-1 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761077s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761077Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/11/2021 | SUPPL-11 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761077s011lbl.pdf | |
| 02/03/2021 | SUPPL-9 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761077s009lbl.pdf | |
| 02/03/2021 | SUPPL-9 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761077s009lbl.pdf | |
| 02/03/2021 | SUPPL-9 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761077s009lbl.pdf | |
| 04/30/2020 | SUPPL-7 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761077s007lbl.pdf | |
| 04/30/2020 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761077s007lbl.pdf | |
| 02/15/2020 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761077s004lbl.pdf | |
| 10/04/2019 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761077s003lbl.pdf | |
| 10/04/2019 | SUPPL-3 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761077s003lbl.pdf | |
| 03/11/2019 | SUPPL-1 |
Efficacy-Manufacturing Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761077s001lbl.pdf | |
| 05/17/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761077s000lbl.pdf |
نظرات کاربران