| Product Information |
|
| Registration Number |
BR-923
|
| Generic Name |
Japanese Encephalitis Vaccine (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: One box contains Type I glass vial (powder), 0.5 mL Type I glass vial (0.4% Sodium Chloride as diluent), each equipped with halobutyl stopper and an aluminum/propylene flip-off cap, with syringe and two needles. (Box of 1'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
|