Veterinary Medicines

VALEMAS 50 mg/ml solution for injection for cattle, sheep, goats, pigs, dogs and cats.

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
VALEMAS 50 mg/ml solution for injection for cattle, sheep, goats, pigs, dogs and cats.
VALEMAS 50 mg/ml solution for injection for cattle, sheep, goats, pigs, dogs and cats.
Active substance:
  • Enrofloxacin
Target species:
  • Pig
  • Cattle
  • Dog
  • Goat
  • Sheep
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Enrofloxacin
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        13
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        5
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        12
        day
    • Goat
      • Meat and offal
        6
        day
      • Milk
        96
        hour
    • Sheep
      • Meat and offal
        4
        day
      • Milk
        72
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Available in:
  • Ireland
Package description:
  • The product is presented in amber Type II glass bottle of 50 ml with chlorobutyl rubber stopper sealed with a flip-off aluminium cap with a tamper-evident polypropylene seal.
  • The product is presented in amber Type II glass bottle of 100 ml with chlorobutyl rubber stoppers sealed with a flip-off aluminium cap with a tamper-evident polypropylene seal.
  • The product is presented in amber Type II glass bottle of 250 ml with chlorobutyl rubber stoppers sealed with a flip-off aluminium cap with a tamper-evident polypropylene seal.

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:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10836/005/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0445/001
Concerned member states:
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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