Veterinary Medicines

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

Authorised
  • Penethamate hydriodide
  • Water for injection
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Product identification

Medicine name:
Novomate 277.8 mg/ml powder and solvent for suspension for injection for cattle
LOHMASTITE 214,5 MG/ML POUDRE ET SOLVANT POUR SUSPENSION INJECTABLE POUR BOVINS
Active substance:
  • Penethamate hydriodide
  • Water for injection
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Penethamate hydriodide
    277.80
    milligram(s)
    /
    1.00
    millilitre(s)
  • Water for injection
    1.00
    other
    /
    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
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Available in:
  • France
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
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Lohmann Pharma Herstellung GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lohmann Pharma Herstellung GmbH
Responsible authority:
  • National Veterinary Medicines Agency
Authorisation number:
  • FR/V/3189558 1/2015
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0613/001
Concerned member states:
  • Belgium
  • Denmark
  • France
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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French (PDF)
Published on: 7/04/2022
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