Veterinary Medicines

Suvaxyn Parvo–E Amphigen

Not authorised
  • Porcine parvovirus, strain S-80, Inactivated
  • Erysipelothrix rhusiopathiae, serotype 2, Inactivated
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Product identification

Medicine name:
Suvaxyn Parvo–E Amphigen
Suvaxyn Parvo/Ery Inaktywowany parwowirus świń, szczep S-80 HI ≥ 94,1*;Inaktywowane bakterie Erysipelothrix rhusiopathiae, serotyp 2, szczep B-7 RP 1-13,5**.(*)Średnia geometryczna miana przeciwciał hamujących hemaglutynację po szczepieniu królików jednądawką stanowiącą połowę rozcieńczenia szczepionki badanej **Moc względna w porównaniu dosurowicy referencyjnej otrzymanej po immunizacji świń szczepionką, która zapewnia wystarczającąochronę,(***) 60% (13,8 mg ) stanowi parafina ciekła Emulsja do wstrzykiwań
Active substance:
  • Porcine parvovirus, strain S-80, Inactivated
  • Erysipelothrix rhusiopathiae, serotype 2, Inactivated
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Porcine parvovirus, strain S-80, Inactivated
    94.10
    haemagglutination inhibiting unit(s)
    /
    2.00
    millilitre(s)
  • Erysipelothrix rhusiopathiae, serotype 2, Inactivated
    13.50
    relative potency
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AL01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Poland
Package description:
  • box containing 1 vial of 50 ml (25 doses)
  • box containing 1 vial of 20 ml (10 doses)

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:
  • Zoetis Polska Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Manufacturing & Research Spain S.L.
  • The Veterinary Medicines Directorate
  • Paul-Ehrlich-Institut
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2682
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0266/001

Documents

Labelling

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Polish (PDF)
Published on: 4/02/2022
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Summary of Product Characteristics

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Polish (PDF)
Published on: 4/02/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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