Veterinary Medicines

GLEPTOVEX 200 mg/ml

Authorised
  • Iron
Download as PDF

Product identification

Medicine name:
GLEPTOVEX 200 mg/ml
GLEPTOVEX 200 mg/ml soluție injectabilă pentru porci
Active substance:
  • Iron
Target species:
  • Pig (piglet)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Iron
    200.00
    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
Available in:
  • Romania
Package description:
  • box containing 10 vials of 200 ml
  • box containing 10 vials of 100 ml
  • box containing 1 vial of 200 ml
  • box containing 1 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:
  • S P Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • S P Veterinaria S.A.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 210154
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0265/001
Concerned member states:
  • Bulgaria
  • Cyprus
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Malta
  • Poland
  • Portugal
  • Romania
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
Download
Romanian (PDF)
Published on: 14/12/2023
Download

Package Leaflet

English (PDF)
Published on: 22/12/2023
Download

Labelling

English (PDF)
Published on: 22/12/2023
Download

eu-PUAR-esv0265001-dcp-gleptovex-200-mg-ml-en.pdf

English (PDF)
Published on: 22/12/2023
Download
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