Veterinary Medicine Information website

Novomate 277.8 mg/ml powder and solvent for suspension for injection for cattle

Authorised
  • Penethamate hydriodide

Product identification

Medicine name:
Novomate 277.8 mg/ml powder and solvent for suspension for injection for cattle
Active substance:
  • Penethamate hydriodide
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Penethamate hydriodide
    277.80
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Powder and solvent for suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        10
        day
      • Milk
        96
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CE90
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Available in:
  • Belgium
Package description:
  • Powder:Colourless, glass vials (siliconised) (50 ml) (type II) closed with rubber stoppers (bromobutyl) and aluminium caps.Solvent:Colourless, glass vials (50 ml) (type II) closed with rubber stoppers (bromobutyl) and aluminium caps.Pack sizes:Cardboard box with 1 pair of vials (10 g powder and 30 ml solvent)
  • Powder:Colourless, glass vials (siliconised) (30 ml) (type I) closed with rubber stoppers (bromobutyl) and aluminium caps.Solvent:Colourless, glass vials (20 ml) (type I) closed with rubber stoppers (bromobutyl) and aluminium caps.Pack sizes:Cardboard box with 6 pairs of vials (5 g powder and 15 ml solvent)
  • Powder:Colourless, glass vials (siliconised) (30 ml) (type I) closed with rubber stoppers (bromobutyl) and aluminium caps.Solvent:Colourless, glass vials (20 ml) (type I) closed with rubber stoppers (bromobutyl) and aluminium caps.Pack sizes:Cardboard box with 2 pairs of vials (5 g powder and 15 ml solvent)
  • Powder:Colourless, glass vials (siliconised) (30 ml) (type I) closed with rubber stoppers (bromobutyl) and aluminium caps.Solvent:Colourless, glass vials (20 ml) (type I) closed with rubber stoppers (bromobutyl) and aluminium caps.Pack sizes:Cardboard box with 1 pair of vials (5 g powder and 15 ml solvent)
  • Powder:Colourless, glass vials (siliconised) (50 ml) (type II) closed with rubber stoppers (bromobutyl) and aluminium caps.Solvent:Colourless, glass vials (50 ml) (type II) closed with rubber stoppers (bromobutyl) and aluminium caps.Pack sizes:Cardboard box with 6 pairs of vials (10 g powder and 30 ml solvent)
  • Powder:Colourless, glass vials (siliconised) (50 ml) (type II) closed with rubber stoppers (bromobutyl) and aluminium caps.Solvent:Colourless, glass vials (50 ml) (type II) closed with rubber stoppers (bromobutyl) and aluminium caps.Pack sizes:Cardboard box with 2 pairs of vials (10 g powder and 30 ml solvent)

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Lohmann Pharma Herstellung GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lohmann Pharma Herstellung GmbH
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0613/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • France
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/08/2025
Updated on: 13/03/2026
Download
French (PDF)
Published on: 18/01/2023
Dutch (PDF)
Published on: 18/08/2025
German (PDF)
Published on: 18/08/2025

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
German (PDF)
Published on: 18/08/2025
French (PDF)
Published on: 18/08/2025

Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
German (PDF)
Published on: 18/08/2025
French (PDF)
Published on: 18/08/2025