Veterinary Medicines

Respiporc FLU3 (--) - Suspension for injection

Authorised
  • Swine influenza virus, A/swine/Haselünne/IDT2617/2003 (H1N1), Inactivated
  • Swine influenza virus, A/swine/Bakum/IDT1769/2003 (H3N2), Inactivated
  • Swine influenza virus, A/swine/Bakum/1832/2000 (H1N2), Inactivated
Download as PDF

Product identification

Medicine name:
Respiporc FLU3 (--) - Suspension for injection
Active substance:
  • Swine influenza virus, A/swine/Haselünne/IDT2617/2003 (H1N1), Inactivated
  • Swine influenza virus, A/swine/Bakum/IDT1769/2003 (H3N2), Inactivated
  • Swine influenza virus, A/swine/Bakum/1832/2000 (H1N2), Inactivated
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Swine influenza virus, A/swine/Haselünne/IDT2617/2003 (H1N1), Inactivated
    Presentation_strength:min. 10.22 log₂ GMNU Reference:Hse Index:0
  • Swine influenza virus, A/swine/Bakum/IDT1769/2003 (H3N2), Inactivated
    Presentation_strength:min. 10.53 log₂ GMNU Reference:Hse Index:1
  • Swine influenza virus, A/swine/Bakum/1832/2000 (H1N2), Inactivated
    Presentation_strength:min. 12.34 log₂ GMNU Reference:Hse Index:2
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Not applicable
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AA03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
Package description:
  • Packaging:Vial (PET), Package_size:8 vials, Content:500 ml (250 doses)
  • Packaging:Vial (PET), Package_size:1 vial, Content:100 ml (50 doses)
  • Packaging:Vial (PET), Package_size:1 vial, Content:50 ml (25 doses)
  • Packaging:Vial (PET), Package_size:1 vial, Content:20 ml (10 doses)
  • Packaging:Vial (glass), Package_size:1 vial, Content:100 ml (50 doses)
  • Packaging:Vial (glass), Package_size:1 vial, Content:50 ml (25 doses)
  • Packaging:Vial (glass), Package_size:1 vial, Content:20 ml (10 doses)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • CEVA Santé Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • IDT Biologika GmbH
  • Ceva-Phylaxia Veterinary Biologicals Co. Ltd.
Responsible authority:
  • European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:

Documents

Combined File of all Documents

English (PDF)
Published on: 29/02/2024
Download
Bulgarian (PDF)
Published on: 29/02/2024
Download
Croatian (PDF)
Published on: 29/02/2024
Download
Czech (PDF)
Published on: 29/02/2024
Download
Danish (PDF)
Published on: 29/02/2024
Download
Dutch (PDF)
Published on: 29/02/2024
Download
Estonian (PDF)
Published on: 29/02/2024
Download
Finnish (PDF)
Published on: 29/02/2024
Download
French (PDF)
Published on: 29/02/2024
Download
German (PDF)
Published on: 29/02/2024
Download
Greek (PDF)
Published on: 29/02/2024
Download
Hungarian (PDF)
Published on: 29/02/2024
Download
Icelandic (PDF)
Published on: 29/02/2024
Download
Italian (PDF)
Published on: 29/02/2024
Download
Latvian (PDF)
Published on: 29/02/2024
Download
Lithuanian (PDF)
Published on: 29/02/2024
Download
Maltese (PDF)
Published on: 29/02/2024
Download
Norwegian (PDF)
Published on: 29/02/2024
Download
Polish (PDF)
Published on: 29/02/2024
Download
Portuguese (PDF)
Published on: 29/02/2024
Download
Romanian (PDF)
Published on: 29/02/2024
Download
Slovak (PDF)
Published on: 29/02/2024
Download
Slovenian (PDF)
Published on: 29/02/2024
Download
Spanish (PDF)
Published on: 29/02/2024
Download
Swedish (PDF)
Published on: 29/02/2024
Download

ema-puar-respiporc-flu3-v-153-par-en.pdf

English (PDF)
Published on: 15/03/2023
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."