| Product Information |
BR-1266_PI_01.pdf
|
| Registration Number |
BR-1266
|
| Generic Name |
Evolocumab
|
| Brand Name |
Repatha
|
| Dosage Strength |
140 mg/mL
|
| Dosage Form |
Solution for Injection in Pre-filled Autoinjector
|
| Classification |
Prescription Drug (Rx)
|
| Packaging |
Prefilled autoinjector/pen (AI/Pen)
with a Type 1 glass prefilled
syringe (PFS)
|
| Pharmacologic Category |
Anti-PCSK9 Monoclonal Antibody
|
| Manufacturer |
Amgen Manufacturing Ltd.
|
| Country of Origin |
U.S.A.
|
| Trader |
|
| Importer |
|
| Distributor |
ZUELLIG PHARMA CORPORATION
|
| Application Type |
Monitored Release
|
| Issuance Date |
23 April 2018
|
| Expiry Date |
23 April 2025
|