Veterinary Medicines

URSOFERRAN 200 mg/ml Solution for injection for pigs

Not authorised
  • Gleptoferron
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Product identification

Medicine name:
URSOFERRAN 200 mg/ml Solution for injection for pigs
Ursoferran 200 mg/ml Roztwór do wstrzykiwań
Active substance:
  • Gleptoferron
Target species:
  • Pig (suckling 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 (suckling 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:
  • Surrendered
Authorised in:
  • Poland
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) 1000 millilitre(s): unspecified outer container with 10 Vial (Glass) each with 100 millilitre(s)
  • (ID2) 100 millilitre(s): unspecified outer container with 1 Vial (Low Density PolyEthylene) 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:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Serumwerk Bernburg AG
Marketing authorisation date:
Manufacturing sites for batch release:
  • Serumwerk Bernburg AG
  • CEVA SANTE ANIMALE - LIBOURNE
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2282
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0149/001

Documents

Combined File of all Documents

English (PDF)
Published on: 10/07/2024
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