Veterinary Medicines

FIXR PRRS inac

Authorised
  • Porcine reproductive and respiratory syndrome virus, type 1, strain Bio-60, Inactivated
  • Porcine reproductive and respiratory syndrome virus, type 2, strain Bio-61, Inactivated
Download as PDF

Product identification

Medicine name:
FIXR PRRS inac
FIXR PRRS inac, emulsie voor injectie voor varkens
Active substance:
  • Porcine reproductive and respiratory syndrome virus, type 1, strain Bio-60, Inactivated
  • Porcine reproductive and respiratory syndrome virus, type 2, strain Bio-61, Inactivated
Target species:
  • Pig (sow)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Porcine reproductive and respiratory syndrome virus, type 1, strain Bio-60, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Porcine reproductive and respiratory syndrome virus, type 2, strain Bio-61, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig (sow)
      • All relevant tissues
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AA05
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • 1 × 10 ml (1 x 5 doses ) - glass vials hydrolytic class I or plastic HDPE vials closed with chlorobutyl rubber stoppers, sealed with aluminum caps in a cardboard box.
  • 10 x 10 ml (10 x 5 doses) - glass vials hydrolytic class I or plastic HDPE vials closed with chlorobutyl rubber stoppers, sealed with aluminum caps in a cardboard box with a grid or PVC box.
  • 1 × 50 ml (1 x 25 doses) - glass vials hydrolytic class II or plastic HDPE vials closed with chlorobutyl rubber stoppers, sealed with aluminum caps in a cardboard box.
  • 1 × 100 ml (1 x 50 doses) - glass vials hydrolytic class II or plastic HDPE vials closed with chlorobutyl rubber stoppers, sealed with aluminum caps in a cardboard box.

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:
  • Kernfarm B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 125906
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0342/001
Concerned member states:
  • Belgium
  • France
  • Germany
  • Portugal
  • Spain

Documents

Combined File of all Documents

English (PDF)
Published on: 18/02/2025
Download
Dutch (PDF)
Published on: 18/02/2025
Download

FIXR PRRS inac_PuAR - update FEB2025.pdf

English (PDF)
Published on: 18/02/2025
Download