Veterinary Medicines

ICTHIOVAC-PD PASTEURELLOSIS DORADA

Authorised
  • Photobacterium damselae, subsp. Piscicida, strain DI21, Inactivated
  • Photobacterium damselae, subsp. Piscicida, strain It-1, Inactivated
Download as PDF

Product identification

Medicine name:
ICTHIOVAC-PD >=60% RPS ΕΝΑΙΩΡΗΜΑ ΕΜΒΑΠΤΙΣΗΣ
ICTHIOVAC-PD PASTEURELLOSIS DORADA
Active substance:
  • Photobacterium damselae, subsp. Piscicida, strain DI21, Inactivated
  • Photobacterium damselae, subsp. Piscicida, strain It-1, Inactivated
Target species:
  • Gilthead
Route of administration:
  • Dipping

Product details

Active substance and strength:
  • Photobacterium damselae, subsp. Piscicida, strain DI21, Inactivated
    60.00
    percent
    /
    1.00
    millilitre(s)
  • Photobacterium damselae, subsp. Piscicida, strain It-1, Inactivated
    60.00
    percent
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Concentrate for dip suspension
Withdrawal period by route of administration:
  • Dipping
    • Gilthead
      • Meat
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI10X
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Greece
Package description:
  • bottle of 1 L

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:
  • National Organization For Medicines
Authorisation number:
  • 103207/19-10-2020/K-0215101
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0215/001
Concerned member states:
  • Croatia
  • Cyprus
  • France
  • Greece
  • Italy
  • Portugal

Documents

Summary of Product Characteristics

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

Labelling

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

eu-PUAR-icthiovac-pd-pasteurellosis-dorada-en.pdf

English (PDF)
Published on: 5/04/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."