Abrysvo
Respiratory syncytial virus vaccine (bivalent, recombinant)
Table of contents
Overview
Abrysvo is a vaccine for protecting against lower respiratory tract disease (LRTD; diseases of the lungs such as bronchitis or pneumonia) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.
It is also for use in mothers during pregnancy to protect their infants against LRTD from birth through 6 months of age.
Abrysvo contains versions of two proteins found on the surface of the virus called RSV subgroup A stabilised prefusion F and RSV subgroup B stabilised prefusion F.
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Abrysvo : EPAR - Medicine Overview (PDF/121.91 KB) (new)
First published: 15/09/2023
EMA/385861/2023 -
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Abrysvo : EPAR - Risk Management Plan (PDF/1.15 MB) (new)
First published: 15/09/2023
Authorisation details
Product details | |
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Name |
Abrysvo
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Agency product number |
EMEA/H/C/006027
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Active substance |
Respiratory syncytial virus, subgroup A, stabilized prefusion F protein / Respiratory syncytial virus, subgroup B, stabilized prefusion F protein
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International non-proprietary name (INN) or common name |
Respiratory syncytial virus vaccine (bivalent, recombinant)
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Therapeutic area (MeSH) |
Respiratory Syncytial Virus Infections
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Anatomical therapeutic chemical (ATC) code |
J07BX05
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Accelerated assessment |
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment. |
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
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Date of issue of marketing authorisation valid throughout the European Union |
23/08/2023
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Contact address |
Boulevard de la Plaine 17 |
Product information
Abrysvo - EMEA/H/C/006027 -
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Vaccines
Therapeutic indication
Abrysvo is indicated for:
- Passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy. See sections 4.2 and 5.1.
- Active immunisation of individuals 60 years of age and older for the prevention of lower respiratory tract disease caused by RSV.
The use of this vaccine should be in accordance with official recommendations.