Veterinary Medicines

Kelamoxil LA 150 mg/ml suspension for injection for cattle and pig

Not authorised
  • Amoxicillin
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Product identification

Medicine name:
Kelamoxil LA 150 mg/ml suspension for injection for cattle and pig
Kelamoxil LA 150 mg/ml Stungulyf, dreifa handa nautgripum og svínum
Active substance:
  • Amoxicillin
Target species:
  • Cattle
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Amoxicillin
    150.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        18
        day
      • Milk
        72
        hour
    • Pig
      • Meat and offal
        20
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Iceland
Package description:
  • Clear PET vial of 250 ml closed with type I laminated chlorobutyl rubber stopper and aluminium cap in a carton box
  • Clear PET vial of 100 ml closed with type I laminated chlorobutyl rubber stopper and aluminium cap in a carton box
  • Clear type II glass vial of 250 ml closed with type I laminated chlorobutyl rubber stopper and aluminium cap in a carton box.
  • Clear type II glass vial of 100 ml closed with type I laminated chlorobutyl rubber stopper and aluminium cap in a carton box.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • KELA Kempisch Laboratorium Kela Laboratoria
Marketing authorisation date:
Manufacturing sites for batch release:
  • KELA Kempisch Laboratorium Kela Laboratoria
Responsible authority:
  • Icelandic Medicines Agency
Authorisation number:
  • IS/2/23/013/01
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0390/001
Generic of:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/08/2023
Updated on: 23/08/2023
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Package Leaflet and Labelling

English (PDF)
Published on: 22/08/2023
Updated on: 23/08/2023
Download

NLV0390001DC_DCP_Kelamoxil LA Final PuAR.pdf

English (PDF)
Published on: 29/02/2024
Download