Veterinary Medicines

Ursocalcin 240 mg/ml + 30 mg/ml solution for infusion for horses, cattle, sheep, goats, pigs

Authorised
  • Calcium gluconate monohydrate
  • Boric acid
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Product identification

Medicine name:
Ursocalcin 240 mg/ml + 30 mg/ml solution for infusion for horses, cattle, sheep, goats, pigs
Ursocalcin 240 mg/ml + 30 mg/ml Solução de infusão para cavalos, bovinos, ovinos, caprinos, suínos
Active substance:
  • Calcium gluconate monohydrate
  • Boric acid
Target species:
  • Cattle
  • Goat
  • Sheep
  • Horse
  • Pig
Route of administration:
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Calcium gluconate monohydrate
    240.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Boric acid
    30.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for infusion
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Goat
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Horse
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Pig
      • Meat and offal
        0
        day
  • Subcutaneous use
    • Cattle
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Goat
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Horse
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA12AA03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Package description:
  • (ID1) 500 millilitre(s): 1 Bottle (polypropylene) with 500 millilitre(s), closed with Stopfen (chlorobutyl rubber)
  • (ID2) 5000 millilitre(s): Box (board) with 10 Bottle (polypropylene) each with 500 millilitre(s), closed with Stopfen (chlorobutyl rubber)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Serumwerk Bernburg AG
Marketing authorisation date:
Manufacturing sites for batch release:
  • Serumwerk Bernburg AG
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 1749/01/25DFVPT
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0352/001
Concerned member states:
  • Italy
  • Portugal
  • Spain
Generic of:

Documents

Combined File of all Documents

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Portuguese (PDF)
Published on: 19/12/2025
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7020235-paren-20251029.pdf

English (PDF)
Published on: 2/01/2026
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