Human medicines European public assessment report (EPAR): Beyfortus, nirsevimab, Date of authorisation: 31/10/2022, Revision: 14, Status: Authorised

Beyfortus RSS Authorised This medicine is authorised for use in the European Union nirsevimab Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Beyfortus is a medicine used to prevent serious lower respiratory tract (lung) disease caused by respiratory syncytial virus (RSV) in newborns and children during their first RSV season. Beyfortus contains the active substance nirsevimab. Expand section Collapse section How is Beyfortus used? The medicine can only be obtained with a prescription. Beyfortus is given as a single injection into the thigh muscle. It is given once before the RSV season starts or at birth for infants born during the RSV season. The recommended dose is 50 mg for children weighing less than 5 kg and 100 mg for children weighing 5 kg or more. For more information about using Beyfortus, see the package leaflet or contact your healthcare provider. How does Beyfortus work? The active substance in Beyfortus, nirsevimab, is a monoclonal antibody. A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen). Nirsevimab attaches to a protein called ‘F protein’ on the surface of RSV. When nirsevimab is attached to this protein, the virus becomes unable to enter the body’s cells, especially those in the lungs. This helps to prevent RSV infection. What benefits of Beyfortus have been shown in studies? Beyfortus was shown to be effective at reducing lower respiratory tract disease caused by RSV in three main studies. One study compared Beyfortus with placebo (a dummy treatment) in 1,490 healthy children born prematurely and at term (at 35 weeks gestation or more). After receiving Beyfortus during their first RSV season, 1.2% of children (12 out of 994) developed RSV-induced lung disease that required medical attention compared with 5% 1 (25 out of 496) in the placebo group. Similar results were seen in a second study comparing Beyfortus with placebo in 1,453 children born five or more weeks prematurely (between 29 and 35 weeks gestation). After receiving Beyfortus during their first RSV season, 2.6% of children (25 out of 969) developed RSV-induced lung disease that required medical attention compared with 9.5% (46 out of 484) in the placebo group. A third study compared Beyfortus with palivizumab (another medicine to prevent RSV-induced lung disease) in children who were either born prematurely, or born at full term but had heart or lung disease which put them at risk of RSV-induced lung disease. After receiving Beyfortus, 4 children (out of 616) developed RSV-induced lung disease that required medical attention compared with 3 children (out of 309) in the group who had palivizumab. 1 Correction of percentage in section “what benefits of Beyfortus have been shown in studies?”: 2.6% has been amended to 5% (25 out of 496) What are the risks associated with Beyfortus? The most common side effects with Beyfortus (which may affect up to 1 in 100 people) are rash occurring within 14 days after injection, and fever and injection site reactions occurring within 7 days after injection. For the full list of side effects and restrictions with Beyfortus, see the package leaflet. Why is Beyfortus authorised in the EU? Beyfortus was shown to be effective at preventing RSV-induced lung disease that required medical attention. In terms of safety, its side effects are considered manageable and in line with what can be expected of this class of medicines. The European Medicines Agency decided that Beyfortus’s benefits are greater than its risks and it can be authorised for use in the EU. What measures are being taken to ensure the safe and effective use of Beyfortus? Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Beyfortus have been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Beyfortus are continuously monitored. Suspected side effects reported with Beyfortus are carefully evaluated and any necessary action taken to protect patients. Other information about Beyfortus Beyfortus received a marketing authorisation valid throughout the EU on 31 October 2022. Beyfortus : EPAR - Medicine Overview Reference Number: EMA/776857/2022 English (EN) (100.35 KB - PDF) First published: 15/11/2022 Last updated: 04/09/2024 View Other languages (22) български (BG) (179.21 KB - PDF) First published: 04/09/2024 View español (ES) (153.37 KB - PDF) First published: 04/09/2024 View čeština (CS) (177.56 KB - PDF) First published: 04/09/2024 View dansk (DA) (152.68 KB - PDF) First published: 04/09/2024 View Deutsch (DE) (156.84 KB - PDF) First published: 04/09/2024 View eesti keel (ET) (151.55 KB - PDF) First published: 04/09/2024 View ελληνικά (EL) (177.42 KB - PDF) First published: 04/09/2024 View français (FR) (155.63 KB - PDF) First published: 04/09/2024 View hrvatski (HR) (176.71 KB - PDF) First published: 04/09/2024 View italiano (IT) (152.92 KB - PDF) First published: 04/09/2024 View latviešu valoda (LV) (186.03 KB - PDF) First published: 04/09/2024 View lietuvių kalba (LT) (175.73 KB - PDF) First published: 04/09/2024 View magyar (HU) (177.1 KB - PDF) First published: 04/09/2024 View Malti (MT) (178.73 KB - PDF) First published: 04/09/2024 View Nederlands (NL) (153.78 KB - PDF) First published: 04/09/2024 View polski (PL) (178.22 KB - PDF) First published: 04/09/2024 View português (PT) (154.69 KB - PDF) First published: 04/09/2024 View română (RO) (174.73 KB - PDF) First published: 04/09/2024 View slovenčina (SK) (175 KB - PDF) First published: 04/09/2024 View slovenščina (SL) (174.51 KB - PDF) First published: 04/09/2024 View Suomi (FI) (151.61 KB - PDF) First published: 04/09/2024 View svenska (SV) (151.79 KB - PDF) First published: 04/09/2024 View Beyfortus : EPAR - Risk management plan English (EN) (743.44 KB - PDF) First published: 15/11/2022 Last updated: 07/10/2024 View Product information Beyfortus : EPAR - Product Information English (EN) (456.83 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View Other languages (24) български (BG) (638.36 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View español (ES) (330.71 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View čeština (CS) (546.77 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View dansk (DA) (527.58 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View Deutsch (DE) (652.77 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View eesti keel (ET) (459.47 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View ελληνικά (EL) (621.49 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View français (FR) (685.24 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View hrvatski (HR) (611.18 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View íslenska (IS) (661.67 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View italiano (IT) (458.24 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View latviešu valoda (LV) (504.95 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View lietuvių kalba (LT) (469.64 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View magyar (HU) (553.63 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View Malti (MT) (625.17 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View Nederlands (NL) (598.67 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View norsk (NO) (541.26 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View polski (PL) (544.4 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View português (PT) (448.92 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View română (RO) (685.01 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View slovenčina (SK) (517.64 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View slovenščina (SL) (541.8 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View Suomi (FI) (605.16 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View svenska (SV) (619.26 KB - PDF) First published: 15/11/2022 Last updated: 01/04/2026 View Latest procedure affecting product information: VR/0000319983 12/03/2026 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). Beyfortus : EPAR - All authorised presentations English (EN) (25.07 KB - PDF) First published: 15/11/2022 View Other languages (24) български (BG) (30.06 KB - PDF) First published: 15/11/2022 View español (ES) (24.98 KB - PDF) First published: 15/11/2022 View čeština (CS) (26.64 KB - PDF) First published: 15/11/2022 View dansk (DA) (26.34 KB - PDF) First published: 15/11/2022 View Deutsch (DE) (28.87 KB - PDF) First published: 15/11/2022 View eesti keel (ET) (23.53 KB - PDF) First published: 15/11/2022 View ελληνικά (EL) (29.53 KB - PDF) First published: 15/11/2022 View français (FR) (25.88 KB - PDF) First published: 15/11/2022 View hrvatski (HR) (27.38 KB - PDF) First published: 15/11/2022 View íslenska (IS) (26.77 KB - PDF) First published: 15/11/2022 View italiano (IT) (24.89 KB - PDF) First published: 15/11/2022 View latviešu valoda (LV) (25.42 KB - PDF) First published: 15/11/2022 View lietuvių kalba (LT) (25.44 KB - PDF) First published: 15/11/2022 View magyar (HU) (28.59 KB - PDF) First published: 15/11/2022 View Malti (MT) (28.54 KB - PDF) First published: 15/11/2022 View Nederlands (NL) (24.65 KB - PDF) First published: 15/11/2022 View norsk (NO) (26.31 KB - PDF) First published: 15/11/2022 View polski (PL) (28.38 KB - PDF) First published: 15/11/2022 View português (PT) (25.47 KB - PDF) First published: 15/11/2022 View română (RO) (27.14 KB - PDF) First published: 15/11/2022 View slovenčina (SK) (25.32 KB - PDF) First published: 15/11/2022 View slovenščina (SL) (24.16 KB - PDF) First published: 15/11/2022 View Suomi (FI) (23.86 KB - PDF) First published: 15/11/2022 View svenska (SV) (25.14 KB - PDF) First published: 15/11/2022 View Product details Name of medicine Beyfortus Active substance nirsevimab International non-proprietary name (INN) or common name nirsevimab Anatomical therapeutic chemical (ATC) code J06BD08 Pharmacotherapeutic group Immune sera and immunoglobulins Therapeutic indication Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in: i. Neonates and infants during their first RSV season. ii. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section 5.1). Beyfortus should be used in accordance with official recommendations. Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in: i. Neonates and infants during their first RSV season. ii. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section 5.1). Beyfortus should be used in accordance with official recommendations. Authorisation details EMA product number EMEA/H/C/005304 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 . PRIME: priority medicine This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines . Marketing authorisation holder Sanofi Winthrop Industrie 82 Avenue Raspail 94250 Gentilly FRANCE Opinion adopted 15/09/2022 Marketing authorisation issued 31/10/2022 Revision 14 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Beyfortus : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (160.39 KB - PDF) First published: 14/02/2025 Last updated: 01/04/2026 View Beyfortus : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (180.41 KB - PDF) First published: 21/03/2023 Last updated: 24/06/2025 View Beyfortus-H-C-005304-II-0005 : EPAR - Assessment report - Variation Reference Number: EMA/355992/2024 English (EN) (7.86 MB - PDF) First published: 24/09/2024 View CHMP post-authorisation summary of positive opinion for Beyfortus (II-05) Adopted Reference Number: EMA/CHMP/37430/2024 English (EN) (209.76 KB - PDF) First published: 28/06/2024 View Beyfortus : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan Reference Number: EMA/182502/2024 English (EN) (92.88 KB - PDF) First published: 05/06/2024 View Beyfortus-H-C-005304-P46-006 : EPAR - Assessment Report English (EN) (881.13 KB - PDF) First published: 15/01/2024 View Initial marketing authorisation documents Beyfortus : EPAR - Public assessment report Adopted Reference Number: EMA/786523/2022 English (EN) (7.24 MB - PDF) First published: 15/11/2022 View News on Beyfortus Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024 28/06/2024 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2024 26/01/2024 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022 16/09/2022 New medicine to protect babies and infants from respiratory syncytial virus (RSV) infection 16/09/2022 Product information – with tracked changes The approved product information for this medicine is available below showing the changes since the previous procedure affecting the product information. The same document without tracked changes is above under 'Product information'. Beyfortus : EPAR – Product information - tracked changes English (EN) (196.38 KB - DOCX) First published: 17/06/2025 View Other languages (24) български (BG) (186.88 KB - DOCX) First published: 17/06/2025 View español (ES) (186.62 KB - DOCX) First published: 17/06/2025 View čeština (CS) (193.26 KB - DOCX) First published: 17/06/2025 View dansk (DA) (236.73 KB - DOCX) First published: 17/06/2025 View Deutsch (DE) (230.53 KB - DOCX) First published: 17/06/2025 View eesti keel (ET) (193.54 KB - DOCX) First published: 17/06/2025 View ελληνικά (EL) (186.83 KB - DOCX) First published: 17/06/2025 View français (FR) (351.3 KB - DOCX) First published: 17/06/2025 View hrvatski (HR) (205.27 KB - DOCX) First published: 17/06/2025 View íslenska (IS) (253.03 KB - DOCX) First published: 17/06/2025 View italiano (IT) (202.59 KB - DOCX) First published: 17/06/2025 View latviešu valoda (LV) (193.74 KB - DOCX) First published: 17/06/2025 View lietuvių kalba (LT) (264 KB - DOCX) First published: 17/06/2025 View magyar (HU) (205.38 KB - DOCX) First published: 17/06/2025 View Malti (MT) (367.88 KB - DOCX) First published: 17/06/2025 View Nederlands (NL) (175.29 KB - DOCX) First published: 17/06/2025 View norsk (NO) (372.53 KB - DOCX) First published: 17/06/2025 View polski (PL) (195.56 KB - DOCX) First published: 17/06/2025 View português (PT) (159.24 KB - DOCX) First published: 17/06/2025 View română (RO) (188.85 KB - DOCX) First published: 17/06/2025 View slovenčina (SK) (250.39 KB - DOCX) First published: 17/06/2025 View slovenščina (SL) (168.47 KB - DOCX) First published: 17/06/2025 View Suomi (FI) (171.78 KB - DOCX) First published: 17/06/2025 View svenska (SV) (170.29 KB - DOCX) First published: 17/06/2025 View More information on Beyfortus EMEA-001784-PIP01-15-M04 - paediatric investigation plan This page was last updated on 01/04/2026 Share this page