| Product Information |
|
| Registration Number |
BR-1000
|
| Generic Name |
Japanese Encephalitis Virus (Live, Attenuated)
|
| Brand Name |
Imojev
|
| Dosage Strength |
Formulation: After reconstitution, one dose (0.5 mL) contains 4.0-5.8 log Plaque Forming Units (PFU) live, attenuated, recombinant Japanese Encephalitis Virus.
|
| Dosage Form |
Powder for Suspension for Injection (SC)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
Packaging: Multi-dose vial (four doses). One box contains Type I glass vial with VVM (powder), 2 mL Type I glass vial (0.9% Sterile Sodium Solution as diluent), each equipped with halobutyl stopper and flip-off cap. (Box of 10's).
|
| Pharmacologic Category |
-
|
| Manufacturer |
Government Pharmaceutical Organization - Merieux Biological Products Co., Ltd.
|
| Country of Origin |
Thailand
|
| Trader |
N/A
|
| Importer |
Zuellig Pharma Corporation
|
| Distributor |
Zuellig Pharma Corporation
|
| Application Type |
Initial (Variation)
|
| Issuance Date |
13 July 2022
|
| Expiry Date |
13 July 2027
|