Veterinary Medicines

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

Authorised
  • Yersinia ruckeri, serotype O1, biotype 1, strain Hagerman, Inactivated
  • Yersinia ruckeri, serotype O1, biotype 2 (EX5), strain SP/07/04, Inactivated
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Product identification

Medicine name:
AquaVac Relera Concentrate for Dip Suspension or Suspension for Injection for Rainbow Trout
Aquavac Relera
Active substance:
  • Yersinia ruckeri, serotype O1, biotype 1, strain Hagerman, Inactivated
  • Yersinia ruckeri, serotype O1, biotype 2 (EX5), strain SP/07/04, Inactivated
Target species:
  • Trout - Golden/Rainbow/Redband/Steelhead
Route of administration:
  • Dipping
  • Intraperitoneal use

Product details

Active substance and strength:
  • Yersinia ruckeri, serotype O1, biotype 1, strain Hagerman, Inactivated
    75.00
    Relative Percentage Survival
    /
    1.00
    millilitre(s)
  • Yersinia ruckeri, serotype O1, biotype 2 (EX5), strain SP/07/04, 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:
  • Germany
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:
  • Intervet Deutschland GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • MSD Animal Health UK Ltd
  • MERCK SHARP & DOHME ANIMAL HEALTH, S.L.
  • The Veterinary Medicines Directorate
Responsible authority:
  • Paul-Ehrlich-Institut
Authorisation number:
  • PEI.V.03634.01.1
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

Labelling

English (PDF)
Published on: 21/10/2024
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Combined File of all Documents

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German (PDF)
Published on: 24/01/2025
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