Veterinary Medicines

TYLMASIN 200 MG/ML SOLUTION FOR INJECTION FOR CATTLE, SHEEP, GOATS AND PIGS

Authorised
  • Tylosin
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Product identification

Medicine name:
TYLMASIN 200 MG/ML SOLUTION FOR INJECTION FOR CATTLE, SHEEP, GOATS AND PIGS
Tylmasin 200 mg/ml solutie injectabila pentru bovine, ovine, caprine si porcine
Active substance:
  • Tylosin
Target species:
  • Cattle
  • Pig
  • Sheep
  • Goat
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Tylosin
    200000.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        28
        day
      • Milk
        108
        hour
    • Pig
      • Meat and offal
        16
        day
    • Sheep
      • Meat and offal
        42
        day
      • Milk
        108
        hour
    • Goat
      • Meat and offal
        42
        day
      • Milk
        108
        hour
  • Intravenous use
    • Cattle
      • Meat and offal
        28
        day
      • Milk
        108
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:

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:
  • Biovet AD
Marketing authorisation date:
Manufacturing sites for batch release:
  • Biovet AD
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 180087
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0240/001
Concerned member states:
  • Austria
  • Bulgaria
  • Denmark
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Poland
  • Portugal
  • Romania
  • Spain

Documents

Combined File of all Documents

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Romanian (PDF)
Published on: 25/07/2022
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