Equilis EHV 1+4

Application withdrawn

The application for this medicine has been withdrawn

Equine herpesvirus vaccine (inactivated)

Overview

The applicant Intervet International B.V. submitted on 26 February 2023 an application for a marketing authorisation to the European Medicines Agency (The Agency) for Equilis EHV 1+4, through the centralised procedure under Article 42(4) of Regulation (EU) 2019/6 (optional scope). 

The eligibility to the centralised procedure was agreed upon by the CVMP on 12 October 2022 as no other marketing authorisation has been granted for the veterinary medicinal product within the Union.

At the time of submission, the applicant applied for the following indications:

Active immunisation of horses to reduce the severity and duration of clinical signs of respiratory disease (rhinopneumonitis), amount and duration of virus excretion and viraemia due to infection with equine herpesvirus 1 and/or equine herpesvirus 4. 

Equilis EHV 1+4 is an inactivated vaccine containing equine herpesvirus 1, strain RAC-H and equine herpesvirus 4, strain 2252 as active substances and Iscom-matrix (containing purified saponin) as adjuvant. The target species is horse. The route of administration is intramuscular.

Equilis EHV 1+4 is presented as a suspension for injection in Type I vials of 1 ml (1 dose) or Type I glass pre-filled syringes of 1 ml (1 dose) in packs containing 10 vials or 10 pre-filled syringes with needles.

The dossier has been submitted in line with the requirements for submissions under Article 8 of Regulation (EU) 2019/6 – full application.

On 19 July 2024, Intervet International B.V. withdrew the application during the clock-stop at day 120 of the procedure. In its letter notifying the Agency of the withdrawal of application, the applicant stated that the reason for the withdrawal is that the currently available resources are not sufficient to solve the issues.

Key facts

• Name of medicine:
  Equilis EHV 1+4
• Active substance:
  equine herpesvirus 1, strain RAC-H and equine herpesvirus 4, strain 2252
• International non-proprietary name (INN) or common name:
  Equine herpesvirus vaccine (inactivated)
• Species:
  Horses
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI05AA05
• EMA product number:
  EMEA/V/C/006147
• Marketing authorisation applicant:
  Intervet International BV
• Withdrawal of application:
  19/07/2024

All documents

Withdrawal assessment report for Equilis EHV 1+4

Adopted Reference Number: EMA/362560/2025

Withdrawal letter: Equilis EHV 1+4