Veterinary Medicines

PERMACYL Powder and solvent for suspension for injection for cattle

Authorised
  • Penethamate hydriodide
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Product identification

Medicine name:
PERMACYL Powder and solvent for suspension for injection for cattle
Permacyl 250.000 IE/ml pulver og solvens til injektionsvæske, suspension
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
        60
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CE90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • box containing 1 x 5,000,000 IU powder vial and 1 x 18 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 10,000,000 IU powder vial and 1 x 36 ml solvent vial
  • box containing 5 x 10,000,000 IU powder vial and 5 x 36 ml solvent vial
  • box containing 10 x 10,000,000 IU powder vial and 10 x 36 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:
  • Danish Medicines Agency
Authorisation number:
  • 54225
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0227/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/04/2023
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Danish (000 IE-ML)
Published on: 29/06/2023
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