Veterinary Medicines

FERROFERON 200 mg/ml Solution for injection for pigs

Authorised
  • Gleptoferron
Download as PDF

Product identification

Medicine name:
FERROFERON 200 mg/ml Solution for injection for pigs
Ursoglepto Vet. 200 mg/ml injektionsvæske, opløsning
Active substance:
  • Gleptoferron
Target species:
  • Pig (sucking piglet)
Route of administration:
  • Subcutaneous use
  • 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:
  • Subcutaneous use
    • Pig (sucking piglet)
      • Meat and offal
        0
        day
  • Intramuscular use
    • Pig (sucking piglet)
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QB03AC
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • (ID6) 2000 millilitre(s): unspecified outer container with 10 Vial (Low Density PolyEthylene) each with 200 millilitre(s)
  • (ID5) 200 millilitre(s): unspecified outer container with 1 Vial (Low Density PolyEthylene) with 200 millilitre(s)
  • (ID4) 1000 millilitre(s): unspecified outer container with 10 Vial (Low Density PolyEthylene) each with 100 millilitre(s)
  • (ID3) 100 millilitre(s): unspecified outer container with 1 Vial (Low Density PolyEthylene) with 100 millilitre(s)
  • (ID2) 1000 millilitre(s): unspecified outer container with 10 Vial (Glass) each with 100 millilitre(s)
  • (ID1) 100 millilitre(s): unspecified outer container with 1 Vial (Glass) with 100 millilitre(s)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Informed consent application (Article 13c of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Iron4u ApS
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
  • Serumwerk Bernburg AG
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 52519
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0157/001
Concerned member states:
  • Belgium
  • Denmark

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/03/2023
Download
Danish (PDF)
Published on: 29/06/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."