| Product Information |
|
| Registration Number |
BR-1448
|
| Generic Name |
Rotavirus Vaccine (Live, Attenuated)
|
| Brand Name |
Rotarix
|
| Dosage Strength |
NLT 106.0 CCID50/1.5 mL
|
| Dosage Form |
Oral Suspension
|
| Classification |
Prescription (RX) Drug
|
| Packaging |
1.75 mL (Net content; 1.5 mL) Type I glass syringe with Type I bromobutyl plunger stopper, polystyrene plunger rod, and polypropylene backstop device (Box of 1's and 10's)
|
| Pharmacologic Category |
-
|
| Manufacturer |
GlaxoSmithKline Biologicals SA (GSK Biolpgicals)
|
| Country of Origin |
Belgium
|
| Trader |
N/A
|
| Importer |
GlaxoSmithKline Philippines, Inc
|
| Distributor |
GlaxoSmithKline Philippines, Inc
|
| Application Type |
Initial
|
| Issuance Date |
18 August 2023
|
| Expiry Date |
18 August 2028
|