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SUIGEN ROTA COLI, EMULSION FOR INJECTION FOR PIGS

Authorised
  • Escherichia coli, serotype K85:987P (fimbrial adhesin F6), Inactivated
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), Inactivated
  • Escherichia coli, serotype O149:K88 (fimbrial adhesin F4ac), Inactivated
  • Porcine rotavirus A, strain OSU 6, Inactivated
  • Escherichia coli, serotype O101:K99 (fimbrial adhesin F5), Inactivated
  • Escherichia coli, serotype O147:K88 (fimbrial adhesin F4ab), Inactivated
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Product identification

Medicine name:
SUIGEN ROTA COLI, EMULSION FOR INJECTION FOR PIGS
Active substance:
  • Escherichia coli, serotype K85:987P (fimbrial adhesin F6), Inactivated
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), Inactivated
  • Escherichia coli, serotype O149:K88 (fimbrial adhesin F4ac), Inactivated
  • Porcine rotavirus A, strain OSU 6, Inactivated
  • Escherichia coli, serotype O101:K99 (fimbrial adhesin F5), Inactivated
  • Escherichia coli, serotype O147:K88 (fimbrial adhesin F4ab), Inactivated
Target species:
  • Pig (for reproduction)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Escherichia coli, serotype K85:987P (fimbrial adhesin F6), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O149:K88 (fimbrial adhesin F4ac), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Porcine rotavirus A, strain OSU 6, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O101:K99 (fimbrial adhesin F5), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O147:K88 (fimbrial adhesin F4ab), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig (for reproduction)
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AL02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Available in:
  • Germany
Package description:
  • Cardboard box 1 × 10 ml (1 x 5 doses) in 10 ml glass vial hydrolytic class I
  • Cardboard box 1 × 50 ml (1 x 25 doses) in 50 ml glass vial hydrolytic class II
  • Cardboard box 1 × 50 ml (1 x 25 doses) in 60 ml HDPE plastic vial
  • Cardboard box 1 × 100 ml (1 x 50 doses) in 100 ml glass vial hydrolytic class II
  • Cardboard box 1 × 100 ml (1 x 50 doses) in 120 ml HDPE plastic vial
  • Cardboard box 1 × 250 ml (1 x 125 doses) in 250 ml HDPE plastic bottle
  • Plastic box 10 × 10 ml (10 x 5 doses) in 10 ml glass vial hydrolytic class I

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:
  • Virbac
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Paul-Ehrlich-Institut
Authorisation number:
  • PEI.V.12117.01.1
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0446/001
Concerned member states:
  • Germany

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 15/08/2022
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 15/08/2022
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Combined File of all Documents

English (PDF)
Published on: 14/03/2026
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eu-puar-frv0446001-mr-rpe703-en.pdf

English (PDF)
Published on: 13/03/2026
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7005808-paren-20220601.pdf

English (PDF)
Published on: 17/09/2024
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