| Product Information |
|
| Registration Number |
BR-1241
|
| Generic Name |
Trastuzumab
|
| Brand Name |
Hertraz
|
| Dosage Strength |
440 mg
|
| Dosage Form |
Powder For Concentrate For Solution For Infusion (IV)
|
| Classification |
Prescription Drug (Rx)
|
| Packaging |
Each box contains: One 50 mL USP Type I glass vial
Each box contains: One 50 mL USP Type I glass vial with chlorobutyl rubber stopper and aluminum seal with blue flip-off cap (drug product) + Two 15 mL (Net content: 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 Pharmaceuticals Private Limited
|
| Importer |
Viatris Pharmaceuticals, Inc
|
| Distributor |
|
| Application Type |
Initial (from Monitored Relase) (Correction)
|
| Issuance Date |
22 April 2024
|
| Expiry Date |
05 October 2027
|