| Product Information |
|
| Registration Number |
BR-1437
|
| Generic Name |
Casirivimab + Imdevimab
|
| Brand Name |
Ronapreve
|
| Dosage Strength |
120 mg/mL
|
| Dosage Form |
Concentrate for Solution for Injection
(SC)/Infusion (IV)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
Co-packaged 6 mL single-use vials Casirivimab: 2.5 mL in 6 mL Type I colorless glass vial with butyl rubber stopper and aluminum seal with dark blue flip-off button. Each casirivimab 6 mL vial contains 300 mg of casirivimab per 2.5 mL (120 mg/mL).
Imdevimab: 2.5 mL in 6 mL Type I colorless glass vial with butyl rubber stopper and aluminum seal with green flip-off button. Each imdevimab 6 mL vial contains 300 mg imdevimab per 2.5 mL (120 mg/mL).
|
| Manufacturer |
Genentech, Inc.
|
| Country of Origin |
United States of America
|
| Trader |
F. Hoffman La Roche Ltd.
|
| Importer |
Roche (Philippines), Inc.
|
| Distributor |
Roche (Philippines), Inc.
|
| Application Type |
Monitored Release (MR)
|
| Issuance Date |
17 January 2023
|
| Expiry Date |
17 January 2028
|