Veterinary Medicines

URSOFERRAN 200 mg/ml Solution for injection for pigs

Authorised
  • Gleptoferron
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Product identification

Medicine name:
URSOFERRAN 200 mg/ml Solution for injection for pigs
Ursoferran 200 mg/ml oplossing voor injectie voor varkens
Active substance:
  • Gleptoferron
Target species:
  • Pig (sucking 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 (sucking 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:
  • Netherlands
Available in:
  • Netherlands
Package description:
  • (ID6): 1 unspecified outer container with 10 Vial (Low Density PolyEthylene) with 200 millilitre(s) (2000 millilitre(s))
  • (ID5): 1 unspecified outer container with 1 Vial (Low Density PolyEthylene) with 200 millilitre(s) (200 millilitre(s))
  • (ID4): 1 unspecified outer container with 10 Vial (Low Density PolyEthylene) with 100 millilitre(s) (1000 millilitre(s))
  • (ID3): 1 unspecified outer container with 10 Vial (Glass) with 100 millilitre(s) (1000 millilitre(s))
  • (ID2): 1 unspecified outer container with 1 Vial (Low Density PolyEthylene) with 100 millilitre(s) (100 millilitre(s))
  • (ID1): 1 unspecified outer container with 1 Vial (Glass) with 100 millilitre(s) (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
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 113079
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0149/001
Concerned member states:
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 17/12/2023
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