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Mamyzin 269.5 mg/ml Powder and Solvent for Suspension for Injection for cattle

Authorised
  • Penethamate hydriodide
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Product identification

Medicine name:
Mamyzin 269.5 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
    269.50
    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
        7
        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:
  • Ireland
Package description:
  • Colourless, Type I Ph Eur glass vials, closed with butyl rubber stoppers and metalcaps containing 5 or 10 g of penethamate hydriodide and 15 or 30 ml solvent toproduce a reconstituted suspension.Pack sizes:10g vials and 30ml solvent x 10
  • Colourless, Type I Ph Eur glass vials, closed with butyl rubber stoppers and metalcaps containing 5 or 10 g of penethamate hydriodide and 15 or 30 ml solvent toproduce a reconstituted suspension.Pack sizes:5g vials and 15ml solvent x 10

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lohmann Pharma Herstellung GmbH
  • Haupt Pharma Latina S.r.l.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10454/009/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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