Veterinary Medicines

LABIMYCIN LA 300 mg/ml SOLUTION FOR INJECTION

Authorised
  • Oxytetracycline dihydrate
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Product identification

Medicine name:
LABIMYCIN LA 300 mg/ml SOLUTION FOR INJECTION
LABIMYCIN LA 300 mg/ml soluție injectabilă
Active substance:
  • Oxytetracycline dihydrate
Target species:
  • Pig
  • Cattle
  • Sheep
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Oxytetracycline dihydrate
    323.50
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        28
        day
    • Cattle
      • Meat and offal
        35
        day
      • Milk
        7
        day
    • Sheep
      • Meat and offal
        35
        day
      • Milk
        9
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01AA06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Available in:
  • Romania
Package description:
  • Box with 10 Vials of 250 ml
  • Box with 10 Vials of 100 ml
  • Box with 12 Vials of 50 ml
  • Box with 1 vial of 250 ml
  • Box with 1 vial of 100 ml
  • Box with 1 Vial of 50 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:
  • Labiana Life Sciences S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • LABIANA LIFE SCIENCES, S.A.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 220070
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0406/001
Concerned member states:
  • Belgium
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Portugal
  • Romania

Documents

Package Leaflet

English (PDF)
Published on: 27/06/2024
Download

Labelling

English (PDF)
Published on: 27/06/2024
Download

eu-PUAR-esv0406001-dcp-labimycin-la-300-mg-ml-solution-for-injection-en.pdf

English (PDF)
Published on: 27/06/2024
Download
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