Veterinary Medicines

belfer 100 mg/ml Solution for injection for horses, cattle, pigs, sheep, goats and dogs

Authorised
  • IRON(III)-HYDROXIDE DEXTRAN COMPLEX
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Product identification

Medicine name:
belfer 100 mg/ml Solution for injection for horses, cattle, pigs, sheep, goats and dogs
Belfer 100 mg/ml
Active substance:
  • IRON(III)-HYDROXIDE DEXTRAN COMPLEX
Target species:
  • Cattle
  • Pig
  • Dog
  • Goat
  • Sheep
  • Horse (suckling foal)
Route of administration:
  • Intravenous use
  • Intramuscular use

Product details

Active substance and strength:
  • IRON(III)-HYDROXIDE DEXTRAN COMPLEX
    333.33
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Pig
      • Meat and offal
        0
        day
  • Intramuscular use
    • Cattle
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Dog
    • Goat
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Sheep
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Pig
      • Meat and offal
        0
        day
    • Horse (suckling foal)
      • Meat and offal
        0
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QB03AC
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Package description:
  • (ID3): 1 unspecified outer container with 12 Vial (Glass) with 100 millilitre(s) (1200 millilitre(s))
  • (ID2): 1 unspecified outer container with 6 Vial (Glass) with 100 millilitre(s) (600 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:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Bela-Pharm GmbH & Co. KG
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bela-Pharm GmbH & Co. KG
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 402337.00.00
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0167/001
Concerned member states:
  • Austria
  • Cyprus
  • Denmark
  • Estonia
  • Finland
  • Greece
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Romania
  • Slovenia
  • Spain
  • Sweden

Documents

Summary of Product Characteristics

English (PDF)
Published on: 14/02/2022
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