AIMOVIG از شرکت AMGEN INC

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

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761077s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761077Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761077Orig1s000TOC.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/11/2021 SUPPL-11 Supplement

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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
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