Veterinary Medicines

ICTHIOVAC VR/PD, EMULSION FOR INJECTION FOR SEA BASS

Authorised
  • Photobacterium damselae, subsp. Piscicida, strain DI21, Inactivated
  • Vibrio anguillarum, serotype O1, Inactivated
  • Vibrio anguillarum, serotype O2b, Inactivated
  • Vibrio anguillarum, serotype O2a, Inactivated
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Product identification

Medicine name:
ICTHIOVAC VR/PD, EMULSION FOR INJECTION FOR SEA BASS
ICTHIOVAC VR/PD, emulzija za injekciju, za lubine
Active substance:
  • Photobacterium damselae, subsp. Piscicida, strain DI21, Inactivated
  • Vibrio anguillarum, serotype O1, Inactivated
  • Vibrio anguillarum, serotype O2b, Inactivated
  • Vibrio anguillarum, serotype O2a, Inactivated
Target species:
  • Seabass
Route of administration:
  • Intraperitoneal use

Product details

Active substance and strength:
  • Photobacterium damselae, subsp. Piscicida, strain DI21, Inactivated
    60.00
    Relative Percentage Survival
    /
    1.00
    Dose
  • Vibrio anguillarum, serotype O1, Inactivated
    75.00
    Relative Percentage Survival
    /
    1.00
    Dose
  • Vibrio anguillarum, serotype O2b, Inactivated
    75.00
    Relative Percentage Survival
    /
    1.00
    Dose
  • Vibrio anguillarum, serotype O2a, Inactivated
    75.00
    Relative Percentage Survival
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intraperitoneal use
    • Seabass
      • Fish meat
        0
        degree day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI10X
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Hipra S.A.
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/22-01/285
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0314/001
Concerned member states:
  • Croatia
  • Cyprus
  • Greece
  • Italy
  • Portugal
  • Spain

Documents

Summary of Product Characteristics

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Croatian (PDF)
Published on: 11/07/2022
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