| Product Information |
|
| Registration Number |
BR-1240
|
| Generic Name |
Trastuzumab
|
| Brand Name |
Hertraz
|
| Dosage Strength |
150 mg
|
| Dosage Form |
Powder for Concentrate for Solution for Infusion
(IV)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
Each box contains: One 15 mL USP Type I glass vial with chlorobutyl rubber stopper and aluminum seal with blue flip-off cap + One 10 mL USP Type I glass vial (1.1% bacteriostatic water for injection as diluent)
|
| Pharmacologic Category |
Monoclonal Antibodies
|
| Manufacturer |
Biocon Biologics India Limited
|
| Country of Origin |
India
|
| Trader |
Mylan Laboratories Limited
|
| Importer |
Viatris Pharmaceuticals, Inc.
|
| Distributor |
Viatris Pharmaceuticals, Inc.
|
| Application Type |
Initial (from Monitored Release)
|
| Issuance Date |
29 March 2023
|
| Expiry Date |
05 October 2027
|