Bovilis Lumpyvax

Opinion

EMA has issued an opinion on this medicine

Lumpy skin disease vaccine (live)

Overview

On 8 October 2026, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the veterinary medicinal product Bovilis Lumpyvax, lyophilisate and solvent for suspension for injection, intended for cattle. The applicant for this veterinary medicinal product is Intervet International B.V.

Bovilis Lumpyvax is an immunological veterinary medicinal product containing live lumpy skin disease virus (LSDV), strain Neethling (ATCvet code QI02AD11) as the active substance and it is intended to stimulate active immunity against LSDV in cattle.

The benefit of Bovilis Lumpyvax is its efficacy in providing active immunisation of cattle to reduce clinical signs and viraemia caused by LSDV.

Injection site swelling, milk production decrease and anorexia are adverse events uncommonly found (1 to 10 animals / 1 000 animals treated).

The full indication is: ‘Active immunisation of cattle to reduce clinical signs and viraemia caused by lumpy skin disease virus (LSDV).

Onset of immunity: 3 weeks.

Duration of immunity: 1 year’ 

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 Bovilis Lumpyvax and therefore recommends the granting of the marketing authorisation under exceptional circumstances.

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Notes: 

• Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.

• Marketing authorisation under exceptional circumstances refers to the fact that in exceptional circumstances an authorisation may be granted subject to certain specific obligations, to be reviewed annually.

CVMP summary of positive opinion for Bovilis Lumpyvax

Adopted Reference Number: EMA/CVMP/219258/2026

Product details

• Name of medicine:
  Bovilis Lumpyvax
• Active substance:
  Lumpy skin disease virus, strain Neethling, live
• International non-proprietary name (INN) or common name:
  Lumpy skin disease vaccine (live)
• Species:
  Cattle
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI02AD11
• EMA product number:
  EMEA/V/C/007001
• Marketing authorisation applicant:
  Intervet International B.V.
• Opinion adopted:
  08/10/2026
• Opinion status:
  Positive