| Product Information |
|
| Registration Number |
BR-1483
|
| Generic Name |
Meningococcal group B Vaccine (rDNA, component,
adsorbed)
|
| Brand Name |
Bexsero
|
| Dosage Strength |
Formulation:
One dose (0.5 mL) contains:
Recombinant Neisseria meningitidis group B NHBA fusion protein1.2.3 -50 mcg Recombinant Neisseria meningitidis-group B NadA protein1.2.3- 50 mcg
Recombinant Neisseria meningitidis group B fHbp fusion protein1.2.3 -50 mcg
Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain 25 mcg
NZ98/254 measured as amount of total protein containing the PorA P1.42
produced in E. coli cells by recombinant DNA technology
2Adsorbed on Aluminum hydroxide (0.5 mg Al1)
'NHBA (Neisseria Heparin Binding Antigen), NadA (Neisseria adhesin A). (Hbp
(factor H binding protein)
|
| Dosage Form |
Suspension for Injection (IM)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Meningococcal Vaccines
|
| Packaging |
0.5 mL in 1.25 mL Luer Lock hydrolytic Type I pre-filled glass syringe with a bromobutyl plunger stopper and rubber tip cap packed with 23G 1 (25mm) and 25G 5/8 (16mm) needles (Box of 1's)
|
| Manufacturer |
GlaxoSmithKline Vaccines S.r.1
|
| Country of Origin |
Italy
|
| Trader |
|
| Importer |
GlaxoSmithKline Philippines, Inc.
|
| Distributor |
|
| Application Type |
Monitored Release (MR)
|
| Issuance Date |
21 May 2024
|
| Expiry Date |
21 May 2029
|