Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Abrysvo powder and solvent for solution for injection.
Respiratory syncytial virus vaccine (bivalent, recombinant).
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection. The powder is white. The solvent is a clear, colourless liquid. |
After reconstitution, one dose (0.5 mL) contains:
RSV subgroup A stabilised prefusion F antigen1,2 60 micrograms
RSV subgroup B stabilised prefusion F antigen1,2 60 micrograms
(RSV antigens)
1 glycoprotein F stabilised in the prefusion conformation
2 produced in Chinese Hamster Ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| RSV glycoprotein F antigen |
RSV glycoprotein F antigen is designed to enhance antigen-specific cellular immune response and neutralizing antibodies response in individuals with pre-existing immunity against RSV. The adjuvant AS01E facilitates the recruitment and activation of antigen presenting cells carrying vaccine-derived antigens in the draining lymph node, which in turn leads to the generation of RSVPreF3-specific CD4+ T cells. |
| List of Excipients |
|---|
|
Powder: Trometamol Solvent: Water for injections |
Vial of antigens for Abrysvo (powder) and pre-filled syringe of solvent:
Powder for 1 dose in a vial (type 1 glass or equivalent) with a stopper (synthetic chlorobutyl rubber) and a flip off cap.
Solvent for 1 dose in a pre-filled syringe (type 1 glass) with a stopper (synthetic chlorobutyl rubber) and a tip cap (synthetic isoprene/bromobutyl blend rubber).
Vial adaptor.
Vial of antigens for Abrysvo (powder) and vial of solvent:
Powder for 1 dose in a vial (type 1 glass or equivalent) with a stopper (synthetic chlorobutyl rubber) and a flip off cap.
Solvent for 1 dose in a vial (type 1 glass or equivalent) with a stopper (bromobutyl rubber) and a flip off cap.
Pack sizes:
Pack containing 1 vial of powder (antigens), 1 pre-filled syringe of solvent, 1 vial adaptor with 1 needle or without needles (1 dose pack).
Pack containing 5 vials of powder (antigens), 5 pre-filled syringes of solvent, 5 vial adaptors with 5 needles or without needles (5 dose pack).
Pack containing 10 vials of powder (antigens), 10 pre-filled syringes of solvent, 10 vial adaptors with 10 needles or without needles (10 dose pack).
Pack containing 5 vials of powder (antigens) and 5 vials of solvent (5 dose pack).
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Date of first authorisation: 23 August 2023
| Drug | Countries | |
|---|---|---|
| ABRYSVO | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Romania, United States |
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