| Product Information |
|
| Registration Number |
BR-1289
|
| Generic Name |
Rotavirus Vaccine (Live, Attenuated)
|
| Brand Name |
Rotasiil
|
| Dosage Strength |
Formulation: After reconstitution, each dose (2.5 mL) contains:
Live Attenuated Bovine-Human Rotavirus Reassortant [G1, G2, G3, G4 and G9]* >10^5.6 FFU/Serotype *Grown on vero cells
|
| Dosage Form |
Freeze-dried Powder for Oral Suspension
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
Type I clear tubular glass vial + Type I glass vial x 2.5 mL (Citrate Bicarbonate buffer solution as diluent) (Box of 1's)
|
| Manufacturer |
Serum Institute of India Private Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Faberco Life Sciences Inc.
|
| Distributor |
N/A
|
| Application Type |
-
|
| Issuance Date |
18 March 2022
|
| Expiry Date |
08 February 2027
|