Veterinary Medicines

VIRBAMEC 10 mg/ml injectable solution for swine

Authorised
  • Ivermectin
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Product identification

Medicine name:
VIRBAMEC 10 mg/ml injectable solution for swine
Virbamec-S, 10mg/ml Injektionslösung für Schweine
Active substance:
  • Ivermectin
Target species:
  • 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
    • Pig
      • Meat and offal
        35
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Package description:
  • (ID3) 500 millilitre(s): unspecified outer container with 1 Vial (Low Density PolyEthylene) with 500 millilitre(s), closed with Stopper and Cap (Rubber, Aluminium)
  • (ID2) 50 millilitre(s): unspecified outer container with 1 Vial (Low Density PolyEthylene) with 50 millilitre(s), closed with Cap and Stopper (Aluminium, Rubber)
  • (ID1) 200 millilitre(s): unspecified outer container with 1 Vial (Low Density PolyEthylene) with 200 millilitre(s), closed with Cap and Stopper (Aluminium, Rubber)

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:
  • Virbac
Marketing authorisation date:
Manufacturing sites for batch release:
  • Sofarimex-Industria Quimica E Farmaceutica S.A.
  • Virbac
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 400362.00.00
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0104/001
Concerned member states:
  • France
  • Luxembourg
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
Download

Combined File of all Documents

English (PDF)
Published on: 14/06/2024
Download
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