Veterinary Medicines

Fenflor 300 mg/ml solution for injection for pigs

Authorised
  • Florfenicol
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Product identification

Medicine name:
Fenflor 300 mg/ml solution for injection for pigs
Fenflor 300 mg/ml Injektionslösung für Schweine
Active substance:
  • Florfenicol
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Florfenicol
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        18
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01BA90
Legal status of supply:
  • Medicinal product on medical prescription for non-renewable delivery
Authorisation status:
  • Valid
Authorised in:
  • Austria
Package description:
  • (ID3): 1 unspecified outer container with 1 Vial (Glass) with 250 millilitre(s) (250 millilitre(s))
  • (ID2): 1 unspecified outer container with 1 Vial (Glass) with 100 millilitre(s) (100 millilitre(s))
  • (ID1): 1 unspecified outer container with 1 Vial (Glass) with 50 millilitre(s) (50 millilitre(s))

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:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • Krka d.d. Novo Mesto
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 8-00770
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0195/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Ireland
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 21/06/2013
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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: 21/06/2013
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Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 21/06/2013
Download
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