| Product Information |
|
| Registration Number |
BR-1434
|
| Generic Name |
Rotavirus Vaccine, (Live
Attenuated)
|
| Brand Name |
Rotasiil-Liquid
|
| Dosage Strength |
Formulation:
Each dose (2 mL) contains:
Live, Attenuated Bovine - Human Rotavirus Reassortant
[G1, G2, G3, G4, and G9]*
*Grown on Vero cells
**FFU= Focus-forming Unit
***CCID= Cell culture infectious disease
≥105.6 FFU**/serotype (NLT 6.30 log10 CCID 50*** per dose)
|
| Dosage Form |
Oral Suspension
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
Single dose. 5 mL (net content: 2 mL) LDPE plastic ampoule with Vaccine Vial Monitor (VVM) (Box of 1's an and 50's).
|
| Manufacturer |
Serum Institute of India Private Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Faberco Life Sciences, Inc.
|
| Distributor |
Faberco Life Sciences, Inc.
|
| Application Type |
Monitored Release
|
| Issuance Date |
28 November 2022
|
| Expiry Date |
28 November 2027
|