ENFLONSIA
As listed in the register: ENFLONSIA 105 mg, solution injectable en seringue préremplie
105 mg · solution injectable
- Prescription only
- Active substance
- Clesrovimab
- Made by
- MERCK SHARP & DOHME (PAYS-BAS)
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (ENFLONSIA). It describes the substance, not this exact product.
ENFLONSIA is a monoclonal antibody with anti-RSV activity [see Microbiology (12.4) ].
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-06-20
Safety of the active substance
From the US prescribing label for the same active substance (ENFLONSIA). It describes the substance, not this exact product.
- ENFLONSIA is contraindicated in infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA [see Warnings and Precautions (5.1) and Description (11) ].
Most common adverse reactions were injection-site erythema (3.8%), injection-site swelling (2.7%) and rash (2.3%).
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
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
European UnionNo exact match for this strength and form
Spain1 matching products
CanadaNo exact match for this strength and form
Details
| Made by | MERCK SHARP & DOHME (PAYS-BAS) |
|---|---|
| Active substance | Clesrovimab |
| Strength | 105 mg |
| Form | solution injectable |
| Route | intramusculaire |
| Dispensing (as stated by the register) | liste I |
| Marketed | Yes, according to the register |
| Reinforced monitoring | Yes — under reinforced monitoring, according to the register |
| Authorisation procedure | Procédure centralisée |
| EU number | EU/1/25/1984 |
| Name in the register | ENFLONSIA 105 mg, solution injectable en seringue préremplie |
| Packs | 1 seringue préremplie en verre de 0,7 mL + 1 aiguille |
| CIS | 61116813 |
| CIP13 | 3400930328613 |
Source: Base de données publique des médicaments · 2026-09-30 · not reviewed by a clinician
Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte. Reuse terms: Licence Ouverte / Open Licence (Etalab).