Eravac

Withdrawn

This medicine's authorisation has been withdrawn

rabbit haemorrhagic disease vaccine (inactivated)

Overview

The marketing authorisation for this product has been withdrawn at the request of the marketing authorisation holder.

Eravac : EPAR - Medicine overview

Product information

Eravac : EPAR - Product Information

Eravac : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Eravac
• Active substance:
  inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strainV-1037
• International non-proprietary name (INN) or common name:
  rabbit haemorrhagic disease vaccine (inactivated)

Pharmacotherapeutic group

Inactivated viral vaccines

Authorisation details

• EMA product number:
  EMEA/V/C/004239
• Withdrawal of marketing authorisation:
  23/10/2026

Assessment history

Changes since initial authorisation of medicine

Eravac : EPAR - Procedural steps taken and scientific information after authorisation

Eravac-V-C-4239-II-0005-G : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/685111/2019

Eravac-V-C-4239-II-0003-G : EPAR - Assessment Report - Variation

Reference Number: EMA/101049/2018

CVMP post-authorisation summary of positive opinion for Eravac

Adopted Reference Number: EMA/CVMP/21684/2018

Initial marketing authorisation documents

Eravac : EPAR - Public assessment report

Adopted Reference Number: EMA/485590/2016

CVMP summary of positive opinion for Eravac

Adopted Reference Number: EMA/CVMP/410201/2016