Veterinary Medicines

AquaVac Relera Concentrate for Dip Suspension or Suspension for Injection for Rainbow Trout

Authorised
  • Yersinia ruckeri, serotype O1, strain Hagerman, Inactivated
  • Yersinia ruckeri, biotype 2, strain EX5, Inactivated
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Product identification

Medicine name:
AquaVac Relera Concentrate for Dip Suspension or Suspension for Injection for Rainbow Trout
AquaVac Relera concentrato per sospensione per immersione o sospensione iniettabile per la trota iridea
AquaVac Relera concentrato per sospensione per immersione o sospensione iniettabile per la trota iridea
Active substance:
  • Yersinia ruckeri, serotype O1, strain Hagerman, Inactivated
  • Yersinia ruckeri, biotype 2, strain EX5, Inactivated
Target species:
  • Trout - Golden/Rainbow/Redband/Steelhead
Route of administration:
  • Dipping
  • Intraperitoneal use

Product details

Active substance and strength:
  • Yersinia ruckeri, serotype O1, strain Hagerman, Inactivated
    75.00
    Relative Percentage Survival
    /
    1.00
    millilitre(s)
  • Yersinia ruckeri, biotype 2, strain EX5, Inactivated
    75.00
    Relative Percentage Survival
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Concentrate for dip suspension
Withdrawal period by route of administration:
  • Dipping
    • Trout - Golden/Rainbow/Redband/Steelhead
      • Meat
        0
        degree day
  • Intraperitoneal use
    • Trout - Golden/Rainbow/Redband/Steelhead
      • Meat
        0
        degree day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI10BB03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • bottle of 1 L

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • MSD Animal Health S.r.l.
Marketing authorisation date:
Manufacturing sites for batch release:
  • MSD Animal Health UK Limited
  • Merck Sharp & Dohme Animal Health S.L.
  • VMD
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 104045
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0309/001
Concerned member states:
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Norway
  • Portugal
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 7/04/2022
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Summary of Product Characteristics

English (PDF)
Published on: 5/04/2023
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