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)
|
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]
|
Pharmacologic Category |
Monoclonal Antibodies
|
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
|