File downloaded on 2026-04-21
Source URL: https://medicines.health.europa.eu/veterinary/en/600000017638
Authorised

Product identification

Medicine name:
Optomease 200mg/ml concentrate for solution for fish treatment
Active substance:
  • Benzocaine
Target species:
  • Atlantic salmon
  • Trout
Route of administration:
  • Water-borne use

Product details

Active substance and strength:
  • Benzocaine
    200.00
    milligram(s)/millilitre
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Concentrate for solution for fish treatment
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN01AX92
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • bottle of 1000 ml
  • bottle of 125 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Virbac
Marketing authorisation date:
Manufacturing sites for batch release:
  • Biofaktor Sp. z o.o.
  • Elara Pharmaservices Europe Limited
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 3885 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0370/001
Concerned member states:
  • Denmark
  • Greece
  • Ireland
  • Norway
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
Download
Spanish (PDF)
Published on: 23/02/2026

Combined File of all Documents

English (PDF)
Published on: 24/07/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 23/02/2026

Package Leaflet

English (PDF)
Published on: 26/11/2025
Download
Spanish (PDF)
Published on: 23/02/2026

eu-PUAR-optomease-200mg-ml-concentrate-for-solution-for-fish-treatment-en.pdf

English (PDF)
Published on: 12/04/2023
Download

es-puar-optomease-200mg-ml-concentrate-for-solution-for-fish-treatment-es.pdf

Spanish (PDF)
Published on: 17/03/2023
Download