Lexylan

Opinion

EMA has issued an opinion on this medicine

Overview

On 13-14 February 2024, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion¹, recommending the granting of a marketing authorisation for the veterinary medicinal product Lexylan, Suspension for injection, intended for cats, cattle and dogs. The applicant for this veterinary medicinal product is Emdoka. The applicant is registered as an SME pursuant to the definition set out in Commission Recommendation 2003/361/EC.
Lexylan is a cephalosporin antibiotic containing cefalexin (ATCvet code QJ01DB01) as active substance.
Cefalexin is a cephalosporin of the first generation and belongs to the beta-lactam antibiotics.
The bactericidal effect of cefalexin is based on interference with the cell membrane synthesis by inactivation of transpeptidase.
Cefalexin is mainly active against Gram-positive organisms:

• Staphylococcus spp. (penicillin-resistant strains included),
• Streptococcus spp.
• Trueperella pyogenes

 The following Gram-negative organisms are moderately sensitive:

• Pasteurella spp.
• Escherichia coli
• Fusobacterium spp.
  Pseudomonas spp., Enterobacter spp. and other Proteus are resistant.

Lexylan is a generic of Ceporex, which has been authorised in the EU since 21 June 1988. Studies have demonstrated the satisfactory quality of Lexylan, and its bioequivalence to the reference product Ceporex. 

The full indication is: 

This veterinary medicinal product is indicated for the treatment of diseases caused by cefalexin susceptible micro-organisms at well accessible infection sites, within the limits of effective cefalexin concentrations.

Cattle:
Metritis, interdigital dermatitis, wounds and abscesses, treatment of septicemic mastitis in addition of an intramammary therapy.
Dogs:
Infections of the respiratory tract, the uro-genital system, the skin, soft tissues and the gastro-intestinal system.
Cats:
Infections of the respiratory tract, the uro-genital system, the skin and soft tissues. 

Detailed conditions for the use of this product are described in the summary of product characteristics (SPC) which will be published in the Union Product Database (UPD) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for Lexylan and therefore recommends the granting of the marketing authorisation.

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¹Summaries of opinion are published without prejudice to the Commission Decision.

CVMP summary of positive opinion for Lexylan

Reference Number: EMA/CVMP/49162/2024

Product details

• Name of medicine:
  Lexylan
• Species:
  • Cats
  • Cattle
  • Dogs
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QJ01DB01
• EMA product number:
  EMEA/V/C/006103
• Marketing authorisation applicant:
  Emdoka BVBA
• Opinion adopted:
  14/02/2024
• Opinion status:
  Positive