Veterinary Medicines

PENETHAONE Powder and solvent for suspension for injection for cattle

Authorised
  • Penethamate hydriodide
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Product identification

Medicine name:
PENETHAONE Powder and solvent for suspension for injection for cattle
Penethaone 236.3 mg/ml Poeder en oplosmiddel voor suspensie voor injectie
Penethaone 236.3 mg/ml Poudre et solvant pour suspension injectable
Penethaone 236.3 mg/ml Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension
Active substance:
  • Penethamate hydriodide
Target species:
  • Cattle (lactating cow)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Penethamate hydriodide
    236.30
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Powder and solvent for suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (lactating cow)
      • Meat and offal
        4
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CE90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • box containing 10 x 10,000,000 IU powder vial and 10 x 36 ml solvent vial
  • box containing 5 x 10,000,000 IU powder vial and 5 x 36 ml solvent vial
  • box containing 1 x 10,000,000 IU powder vial and 1 x 36 ml solvent vial
  • box containing 10 x 5,000,000 IU powder vial and 10 x 18 ml solvent vial
  • box containing 5 x 5,000,000 IU powder vial and 5 x 18 ml solvent vial
  • box containing 1 x 5,000,000 IU powder vial and 1 x 18 ml solvent vial

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Divasa Farmavic S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Divasa Farmavic S.A.
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:
  • Spain
Procedure number:
  • ES/V/0226/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 26/12/2023
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Dutch (PDF)
Published on: 17/08/2025
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French (PDF)
Published on: 17/08/2025
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German (PDF)
Published on: 17/08/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 17/08/2025
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French (PDF)
Published on: 17/08/2025
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German (PDF)
Published on: 17/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 17/08/2025
Download
French (PDF)
Published on: 17/08/2025
Download
German (PDF)
Published on: 17/08/2025
Download