Veterinary Medicines

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

Authorised
  • Penethamate hydriodide
Download as PDF

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
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."