Veterinary Medicines

Suibiovac Ery Inaktywowane bakterie:-Erysipelothrix rhusiopathiae szczep OV1 (serotyp 1) R.P* ≥ 1-Erysipelothrix rhusiopathiae szczep OV2 (serotyp 2) R.P* ≥ 1(*) względna moc oznaczona metodą in-vitro w porównaniu do szczepionki referencyjnej zgodnie zFarmakopeą Europejską. Zawiesina do wstrzykiwań

Authorised
  • Erysipelothrix rhusiopathiae, serotype 1, strain OV1, Inactivated
  • Erysipelothrix rhusiopathiae, serotype 2, strain OV2, Inactivated
Download as PDF

Product identification

Medicine name:
Suibiovac Ery Inaktywowane bakterie:-Erysipelothrix rhusiopathiae szczep OV1 (serotyp 1) R.P* ≥ 1-Erysipelothrix rhusiopathiae szczep OV2 (serotyp 2) R.P* ≥ 1(*) względna moc oznaczona metodą in-vitro w porównaniu do szczepionki referencyjnej zgodnie zFarmakopeą Europejską. Zawiesina do wstrzykiwań
Active substance:
  • Erysipelothrix rhusiopathiae, serotype 1, strain OV1, Inactivated
  • Erysipelothrix rhusiopathiae, serotype 2, strain OV2, Inactivated
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Erysipelothrix rhusiopathiae, serotype 1, strain OV1, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Erysipelothrix rhusiopathiae, serotype 2, strain OV2, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AB03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Biowet Drwalew Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Drwalewskie Zaklady Przemyslu Bioweterynaryjnego S.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2077
Date of authorisation status change:

Documents

Labelling

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

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
Download

Summary of Product Characteristics

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