| Product Information |
|
| Registration Number |
BR-1489
|
| Generic Name |
Respiratory Syncytial Virus Vaccine (Bivalent, Recombinant)
|
| Brand Name |
Abrysvo
|
| Dosage Strength |
Formulation:
After reconstitution, 0.5mL (one dose) contains:
RSV subgroup A stabilized prefusion F antigen 1.2
60 micrograms
RSV subgroup B stabilized prefusion F antigen 1.2
60 micrograms (RSV antigens)
1 glycoprotein F stabilized in the prefusion conformation
2 produced in Chinese Hamster Ovary cells by recombinant DNA technology.
|
| Dosage Form |
Lyophilized Powder and Solvent for
Solution for Intramuscular Injection
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Vaccine
|
| Packaging |
(1) 2 mL type I borosilicate glass vial with 13 mm vial stopper and aluminum vial seal with tamper-evident polypropylene flip off cap [vaccine] + (1) 1 mL pre-filled syringe type I borosilicate glass with plastic Luer lock adapter and a synthetic isoprene bromobutyl rubber tip cap with a plastic rigid tip cap cover and chlorobutyl rubber plunger stopper [water for injection (solvent)] + (1) 13 mm vial adapter + (1) 25G needle [Box of 1's]
|
| Manufacturer |
Pfizer Manufacturing Belgium NV
|
| Country of Origin |
Belgium
|
| Trader |
|
| Importer |
Pfizer, Inc.
|
| Distributor |
|
| Application Type |
Monitored Release
|
| Issuance Date |
18 September 2024
|
| Expiry Date |
18 September 2029
|