Veterinary Medicines

Prinovox 40 mg + 10 mg spot-on solution for small dogs

Authorised
  • Moxidectin
  • Imidacloprid
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Product identification

Medicine name:
Prinovox 40 mg + 10 mg spot-on solution for small dogs
PRINOVOX
Active substance:
  • Moxidectin
  • Imidacloprid
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Moxidectin
    10.00
    milligram(s)
    /
    0.40
    millilitre(s)
  • Imidacloprid
    40.00
    milligram(s)
    /
    0.40
    millilitre(s)
Pharmaceutical form:
  • Spot-on solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AB52
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • (ID6) 8.4 millilitre(s): unspecified outer container with 21 Pipette (polypropylene) each with 0.4 millilitre(s)
  • (ID5) 2.4 millilitre(s): unspecified outer container with 6 Pipette (polypropylene) each with 0.4 millilitre(s)
  • (ID4) 1.6 millilitre(s): unspecified outer container with 4 Pipette (polypropylene) each with 0.4 millilitre(s)
  • (ID3) 1.2 millilitre(s): unspecified outer container with 3 Pipette (polypropylene) each with 0.4 millilitre(s)
  • (ID2) 0.8 millilitre(s): unspecified outer container with 2 Pipette (polypropylene) each with 0.4 millilitre(s)
  • (ID1) 0.4 millilitre(s): unspecified outer container with 1 Pipette (polypropylene) with 0.4 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:
  • Elanco Italia S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • KVP Pharma+Veterinaer Produkte GmbH
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 105081
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0196/003
Concerned member states:
  • Ireland
  • Italy
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Italian (PDF)
Published on: 3/06/2022
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