Beyfortus
- Prescription status not stated
- Antibiotics, antivirals and antifungals taken into the body
- Active substance
- Nirsevimab
- Made by
- Sanofi Winthrop Industrie
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- 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.
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (BEYFORTUS). It describes the substance, not this exact product.
BEYFORTUS is a monoclonal antibody with anti-RSV activity [see Microbiology (12.4) ].
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-07-13
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Sanofi Winthrop Industrie |
|---|---|
| Active substance | Nirsevimab |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Classification | J06BD08 · Antibiotics, antivirals and antifungals taken into the body |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2022-10-31 |
| Last updated by the regulator | 2026-04-24 |
| EMA product number | EMEA/H/C/005304 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).