Veterinary Medicines

GLEPTAFER 200 mg/ml solution for injection for pigs

Authorised
  • Gleptoferron
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Product identification

Medicine name:
GLEPTAFER 200 mg/ml solution for injection for pigs
GLEPTAFER 200 mg/ml solutie injectabila pentru porcine
Active substance:
  • Gleptoferron
Target species:
  • Pig (piglet)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Gleptoferron
    532.60
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig (piglet)
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QB03AC
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:
  • box containing 1 vial of 100 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a 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.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 220145
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0284/001
Concerned member states:
  • Poland
  • Portugal
  • Romania

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/03/2023
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Romanian (PDF)
Published on: 18/06/2024
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Package Leaflet

English (PDF)
Published on: 24/03/2023
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Labelling

English (PDF)
Published on: 24/03/2023
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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eu-PUAR-gleptafer-200-mg-ml-solution-for-injection-for-pigs-en.pdf

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