Clesrovimab: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 28, 2026🚩 Report this page

Clesrovimab

Antiviral Monoclonal Antibodies

Sold as Enflonsia

GB MHRAEU EMACA Health Canada

Drug class: Antiviral Monoclonal Antibodies
Availability: See label
Routes: Intramuscular
Markets covered: 3
Products on record: 3

Overview

Clesrovimab is an active pharmaceutical ingredient in the Antiviral Monoclonal Antibodies group (J06BD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	1	April 28, 2026
EU European Union	EMA	1	April 22, 2026
CA Canada	Health Canada	1	April 20, 2026

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised April 28, 2026[1]

ENFLONSIA is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season. ENFLONSIA should be used in accordance with official recommendations.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised April 22, 2026[2]

Enflonsia is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season. Enflonsia should be used in accordance with official recommendations.

How to take

CACanada· Health Canada

1 product

1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (1)

ENFLONSIAMERCK CANADA INC

Sources & citations

[1]MHRA (UK) · PL530950109 · revised April 28, 2026
[2]European Medicines Agency · EMEA/H/C/006497 · revised April 22, 2026
[3]Health Canada (DPD) · 02565145 · revised April 20, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised April 28, 2026[1]

3%). Most (> 96%) of the adverse reactions were mild or moderate. 1). Table 1 presents the adverse reactions reported in 2 409 preterm and full-term infants (GA ≥ 29 weeks) who received clesrovimab. Adverse reactions reported with clesrovimab are listed by MedDRA system organ class and in decreasing order of frequency.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), and very rare (< 1/10 000) and not known (cannot be estimated from available data). 1) was similar to palivizumab (450 infants) and consistent with the safety profile of clesrovimab in infants in Study 004.
Serious adverse events reported in early preterm infants GA < 29 weeks were similar in number and pattern between recipients of clesrovimab (21/97 participants) and palivizumab (31/108 participants). 1) across the age- groups in each study.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised April 28, 2026[1]

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity including anaphylaxis If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, appropriate treatment and/or supportive therapy should be initiated.
Individuals with thrombocytopenia and coagulation disorders As with any other intramuscular injections, clesrovimab should be given with caution to infants with thrombocytopenia or any coagulation disorder, because bleeding or bruising may occur following an intramuscular administration in these individuals.
14 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised April 22, 2026[2]

3%). Most (> 96%) of the adverse reactions were mild or moderate. 1). Table 1 presents the adverse reactions reported in 2 409 preterm and full-term infants (GA ≥ 29 weeks) who received clesrovimab. Adverse reactions reported with clesrovimab are listed by MedDRA system organ class and in decreasing order of frequency.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), and very rare (< 1/10 000) and not known (cannot be estimated from available data). 1) was similar to palivizumab (450 infants) and consistent with the safety profile of clesrovimab in infants in Study 004.
Serious adverse events reported in early preterm infants GA < 29 weeks were similar in number and pattern between recipients of clesrovimab (21/97 participants) and palivizumab (31/108 participants). 1) across the age-groups in each study.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised April 22, 2026[2]

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity including anaphylaxis If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, appropriate treatment and/or supportive therapy should be initiated.
Individuals with thrombocytopenia and coagulation disorders As with any other intramuscular injections, clesrovimab should be given with caution to infants with thrombocytopenia or any coagulation disorder, because bleeding or bruising may occur following an intramuscular administration in these individuals.
14 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

GBUnited Kingdom· MHRA

EUEuropean Union· EMA

CACanada· Health Canada

Drugs in the same class

Sources & citations