| Product Information |
|
| Registration Number |
BRP-120
|
| Generic Name |
Trastuzumab
|
| Brand Name |
Ogivri
|
| Dosage Strength |
420 mg
|
| Dosage Form |
Powder for Concentrate for Solution for Infusion (IV)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
Packaging: Multidose. 50 mL Type I borosilicate glass vial with grey chlorobutyl rubber stopper sealed with lavender aluminum and propylene flip-off cap + 20 mL Type I borosilicate glass vial with grey chlorobutyl rubber stopper sealed with red aluminum and propylene flip-off cap [Bacteriostatic Water for Injection (BWFI) as diluent] (Box of l's).
|
| Pharmacologic Category |
-
|
| Manufacturer |
Biocon Biologics India Limited
|
| Country of Origin |
India
|
| Trader |
Mylan Pharmaceuticals Private Limited
|
| Importer |
Viatris Pharmaceuticals, Inc.
|
| Distributor |
Viatris Pharmaceuticals, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
24 January 2023
|
| Expiry Date |
24 January 2028
|