Veterinary Medicines

FIXR Rota Corona Coli, emulsion for injection for cattle

Authorised
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
  • Escherichia coli, serotype O8:K35 (fimbrial adhesin F5), strain 3014 and serotype O9:K35 (fimbrial adhesin F5), strain 3015 and serotype O101:K30 (fimbrial adhesin F5), strain 3016, Inactivated
  • Bovine coronavirus, strain C-197, Inactivated
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Product identification

Medicine name:
FIXR Rota Corona Coli, emulsion for injection for cattle
Fixr Rota Corona Coli, emulsie voor injectie voor runderen
Active substance:
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
  • Escherichia coli, serotype O8:K35 (fimbrial adhesin F5), strain 3014 and serotype O9:K35 (fimbrial adhesin F5), strain 3015 and serotype O101:K30 (fimbrial adhesin F5), strain 3016, Inactivated
  • Bovine coronavirus, strain C-197, Inactivated
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O8:K35 (fimbrial adhesin F5), strain 3014 and serotype O9:K35 (fimbrial adhesin F5), strain 3015 and serotype O101:K30 (fimbrial adhesin F5), strain 3016, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Bovine coronavirus, strain C-197, Inactivated
    1.00
    unit(s)
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • All relevant tissues
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AL01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • 50 ml (25 doses) hydrolytic class II glass vial with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • 50 ml (25 doses) HDPE vial with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • 100 ml (50 doses) hydrolytic class II glass vial with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • Cardboard box containing 10 x 10 ml (10 x 5 doses) HDPE vials with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • 100 ml (50 doses) HDPE vial with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • 10 ml (5 doses) hydrolytic class I glass vial with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • 10 ml (5 doses) HDPE vial with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • Cardboard box containing 2 x 2 ml (2 x 1 dose) hydrolytic class I glass vials with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • Cardboard box containing 12 x 50 ml (12 x 25 doses) hydrolytic class II glass vials with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • Cardboard box containing 12 x 50 ml (12 x 25 doses) HDPE vials with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • Cardboard box containing 12 x 100 ml (12 x 50 doses) hydrolytic class II glass vials with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • Cardboard box containing 12 x 100 ml (12 x 50 doses) HDPE vials with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • Cardboard box containing 24 x 50 ml (24 x 25 doses) HDPE vials with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • Cardboard box containing 20 x 2 ml (20 x 1 dose) hydrolytic class I glass vials with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • Cardboard box containing 20 x 100 ml (20 x 50 doses) hydrolytic class II glass vials with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • Cardboard box containing 20 x 100 ml (20 x 50 doses) HDPE vials with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • Cardboard box containing 5 x 10 ml (5 x 5 doses) hydrolytic class I glass vials with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • Cardboard box containing 5 x 10 ml (5 x 5 doses) HDPE vials with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • Cardboard box containing 24 x 50 ml (24 x 25 doses) hydrolytic class II glass vials with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • Cardboard box containing 10 x 10 ml (10 x 5 doses) hydrolytic class I glass vials with a chlorobutyl pierceable stopper sealed with an aluminium cap
  • Cardboard box containing 10 x 2 ml (10 x 1 dose) hydrolytic class I glass vials with a chlorobutyl pierceable stopper sealed with an aluminium cap

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Similar biological application (Article 13(4) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Kernfarm B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 127867
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0361/001
Concerned member states:
  • Belgium

Documents

Combined File of all Documents

English (PDF)
Published on: 29/03/2022
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Dutch (PDF)
Published on: 4/04/2022
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FIXR Rota Corona Coli_PuAR - FINAL.pdf

English (PDF)
Published on: 29/03/2022
Download