Veterinary Medicines

ENROSYVA 100 mg/ml

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
ENROSYVA 100 mg/ml
ENROSYVA 100MG/ML ΕΝΕΣΙΜΟ ΔΙΑΛΥΜΑ
Active substance:
  • Enrofloxacin
Target species:
  • Cattle
  • Pig
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Enrofloxacin
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        13
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        13
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        13
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
This information is not available for this product.
Authorisation status:
  • Valid
Authorised in:
  • Greece
Available in:
  • Greece
Package description:
  • polypropylene vial of 250 ml
  • box containing 1 glass vial of 100 ml

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:
  • Laboratorios Syva S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Syva S.A.U.
Responsible authority:
  • National Organization For Medicines
Authorisation number:
  • 105063/08-11-2021/K-0233201
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0247/001
Concerned member states:
  • Greece
  • Italy
  • Poland
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/04/2023
Download

Package Leaflet

English (PDF)
Published on: 11/04/2023
Download

Labelling

English (PDF)
Published on: 11/04/2023
Download

eu-PUAR-enrosyva-100-mg-ml-en.pdf

English (PDF)
Published on: 11/04/2023
Download
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