ENFLONSIA Solution for injection Ref.[116536] Active ingredients: Clesrovimab

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

Enflonsia 105 mg solution for injection in pre-filled syringe.

Pharmaceutical Form

Solution for injection (injection).

Clear to slightly opalescent, colourless to slightly yellow solution, with a pH of 5.5–6.5, and an osmolality of 320–420 mOsm/kg.

Qualitative and quantitative composition

Each pre-filled syringe contains 105 mg of clesrovimab in 0.7 mL.

Clesrovimab is a fully human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.

Excipient with known effect:

This medicinal product contains 0.14 mg of polysorbate 80 in each 105 mg (0.7 mL) dose.

For the full list of excipients, see section 6.1.

Active Ingredient

Clesrovimab is a fully human immunoglobulin G1 kappa (IgG1κ) neutralising monoclonal antibody with a triple amino acid substitution (YTE) in the Fc region which increases binding to the neonatal Fc receptor leading to an extended serum half-life. Clesrovimab provides passive immunity by targeting the RSV outer membrane fusion (F) protein to prevent viral entry into cells.
List of Excipients

Histidine
Histidine hydrochloride monohydrate
Arginine hydrochloride
Sucrose
Polysorbate 80 (E433)
Water for injections

Pack sizes and marketing

0.7 mL solution in pre-filled syringe (Type I glass) with a plunger stopper and a tip cap with or without needles.

Enflonsia is available in the following pack sizes:

  • 1 pre-filled syringe
  • 1 pre-filled syringe + 1 needle
  • 1 pre-filled syringe + 2 needles
  • 10 pre-filled syringes
  • 10 pre-filled syringes + 10 needles
  • 10 pre-filled syringes + 20 needles
  • Multipacks containing 50 (5 packs of 10) pre-filled syringes

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

EU/1/25/1984/001
EU/1/25/1984/002
EU/1/25/1984/003
EU/1/25/1984/004
EU/1/25/1984/005
EU/1/25/1984/006
EU/1/25/1984/007

Drugs

Drug Countries
ENFLONSIA United Kingdom, United States
 
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