Veterinary Medicines

IVERTOTAL 10 mg/ml solution for injection

Authorised
  • Ivermectin
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Product identification

Medicine name:
IVERTOTAL 10 mg/ml solution for injection
IVERTOTAL 10 mg/ml SOLUCION INYECTABLE
Active substance:
  • Ivermectin
Target species:
  • Cattle
  • Sheep
  • Pig
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Ivermectin
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        49
        day
      • Milk
        no withdrawal period
    • Sheep
      • Meat and offal
        42
        day
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        28
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:
  • box containing 10 polypropylene vials of 500 ml
  • box containing 1 polypropylene vial of 500 ml
  • box containing 1 polypropylene vial of 250 ml
  • box containing 10 polypropylene vials of 250 ml

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:
  • S P Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • S P Veterinaria S.A.
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2937 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0311/001
Concerned member states:
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/04/2023
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Spanish (PDF)
Published on: 24/07/2024
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Package Leaflet

English (PDF)
Published on: 11/04/2023
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Spanish (PDF)
Published on: 5/02/2025
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Labelling

English (PDF)
Published on: 11/04/2023
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Spanish (PDF)
Published on: 24/07/2024
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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eu-PUAR-ivertotal-10-mg-ml-solution-for-injection-en.pdf

English (PDF)
Published on: 11/04/2023
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es-puar-ivertotal-10-mg-ml-solution-for-injection-es.pdf

Spanish (PDF)
Published on: 17/03/2023
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