Novomate 277.8 mg/ml powder and solvent for suspension for injection for cattle
Novomate 277.8 mg/ml powder and solvent for suspension for injection for cattle
Authorised
- Penethamate hydriodide
- Water for injection
Product identification
Medicine name:
Novomate 277.8 mg/ml Poudre et solvant pour suspension injectable
Novomate 277.8 mg/ml Poeder en oplosmiddel voor suspensie voor injectie
Novomate 277.8 mg/ml Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension
Novomate 277.8 mg/ml powder and solvent for suspension for injection for cattle
Active substance:
- Penethamate hydriodide
- Water for injection
Target species:
-
Cattle
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Penethamate hydriodide277.80milligram(s)1.00millilitre(s)
-
Water for injection1.00other1.00millilitre(s)
Pharmaceutical form:
-
Powder and solvent for suspension for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle
-
Meat and offal10day
-
Milk96hour
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01CE90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
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
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:
- 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:
-
Belgium
-
Denmark
-
France
-
Netherlands
-
Poland
-
Portugal
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Package Leaflet
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