| Product Information |
|
| Registration Number |
BRP-113
|
| Generic Name |
Trastuzumab
|
| Brand Name |
Ogivri
|
| Dosage Strength |
420 mg
|
| Dosage Form |
Lyophilized Powder for Concentrate for Solution
for Infusion (IV)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
Single dose. 50 mL Type I glass vial with grey chlorobutyl rubber stopper sealed with aluminum and lavender plastic flip-off cap (Box of l’s)
|
| Pharmacologic Category |
Monoclonal Antibodies (HER2 Inhibitors)
|
| Manufacturer |
Biocon Biologics India Limited
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Mylan Philippines, Inc.
|
| Distributor |
Mylan Philippines, Inc.
|
| Application Type |
Initial (Re-application)
|
| Issuance Date |
22 July 2022
|
| Expiry Date |
22 July 2027
|