Veterinary Medicines

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

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 suspenzija za injiciranje za govedo in prašiče
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:
  • Valid
Authorised in:
  • Slovenia
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:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • DC/V/0786/001
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0390/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
This information is not available for this product.

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/08/2023
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Slovenian (PDF)
Published on: 16/11/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 16/11/2023
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 16/11/2023
Download

Package Leaflet and Labelling

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

NLV0390001DC_DCP_Kelamoxil LA Final PuAR.pdf

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