Source: European Medicines Agency (EU) Revision Year: 2023 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 |
Powder:
Powder for 1 dose in a vial (type 1 glass or equivalent) with a stopper (synthetic chlorobutyl rubber) and a flip off cap.
Solvent:
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:
Sterile vial adaptor.
Pack size:
Pack containing 1 vial of powder, 1 pre-filled syringe of solvent, 1 vial adaptor with 1 needle or without needles.
Pack containing 5 vials of powder, 5 pre-filled syringes of solvent, 5 vial adaptors with 5 needles or without needles.
Pack containing 10 vials of powder, 10 pre-filled syringes of solvent, 10 vial adaptors with 10 needles or without needles.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/23/1752/001 – 1 vial, 1 vial adaptor, 1 pre-filled syringe, 1 needle
EU/1/23/1752/002 – 1 vial, 1 vial adaptor, 1 pre-filled syringe
EU/1/23/1752/003 – 5 vials, 5 vial adaptors, 5 pre-filled syringes, 5 needles
EU/1/23/1752/004 – 5 vials, 5 vial adaptors, 5 pre-filled syringes
EU/1/23/1752/005 – 10 vials, 10 vial adaptors, 10 pre-filled syringes, 10 needles
EU/1/23/1752/006 – 10 vials, 10 vial adaptors, 10 pre-filled syringes
| Drug | Countries | |
|---|---|---|
| ABRYSVO | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Romania, United States |
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