| 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
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Monoclonal Antibodies
|
| Packaging |
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)
|
| Manufacturer |
Biocon Limited
|
| Country of Origin |
India
|
| Trader |
Mylan Laboratories Limited
|
| Importer |
Zuellig Pharma Corporation
|
| Distributor |
Zuellig Pharma Corporation
|
| Application Type |
Initial (from Monitored Release)
|
| Issuance Date |
18 August 2022
|
| Expiry Date |
05 October 2027
|