| Product Information |
|
| Registration Number |
BR-1400
|
| Generic Name |
Trastuzumab
|
| Brand Name |
Trazimera
|
| Dosage Strength |
440 mg
|
| Dosage Form |
Powder for Concentrate for Solution for Infusion (IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Monoclonal Antibodies
|
| Packaging |
30 mL Type I clear glass vial with chlorobutyl
stopper sealed with aluminum and flip-off cap (drug product) + 20 mL Type I clear glass vial with bromobutyl rubber stopper sealed with aluminum and flip-off cap (Bacteriostatic Water for Injection as diluent) [Box of 1's]
|
| Manufacturer |
Pfizer Manufacturing Belgium NV
|
| Country of Origin |
Belgium
|
| Trader |
N/A
|
| Importer |
Pfizer, Inc.
|
| Distributor |
Pfizer, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
21 April 2022
|
| Expiry Date |
21 April 2027
|