Veterinary Medicines

Prinovox 250 mg + 62.5 mg spot-on solution for large dogs

Authorised
  • Moxidectin
  • Imidacloprid
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Product identification

Medicine name:
Prinovox 250 mg + 62.5 mg spot-on solution for large dogs
PRINOVOX
Active substance:
  • Moxidectin
  • Imidacloprid
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Moxidectin
    62.50
    milligram(s)
    /
    2.50
    millilitre(s)
  • Imidacloprid
    250.00
    milligram(s)
    /
    2.50
    millilitre(s)
Pharmaceutical form:
  • Spot-on solution
Withdrawal period by route of administration:
  • Cutaneous use
    • Dog
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): 1 unspecified outer container with 21 Pipette (PolyPropylene) with 2.5 millilitre(s) (52.5 millilitre(s))
  • (ID5): 1 unspecified outer container with 6 Pipette (PolyPropylene) with 2.5 millilitre(s) (15.0 millilitre(s))
  • (ID4): 1 unspecified outer container with 4 Pipette (PolyPropylene) with 2.5 millilitre(s) (10.0 millilitre(s))
  • (ID3): 1 unspecified outer container with 3 Pipette (PolyPropylene) with 2.5 millilitre(s) (7.5 millilitre(s))
  • (ID2): 1 unspecified outer container with 2 Pipette (PolyPropylene) with 2.5 millilitre(s) (5.0 millilitre(s))
  • (ID1): 1 unspecified outer container with 1 Pipette (PolyPropylene) with 2.5 millilitre(s) (2.5 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+Veterinär Produkte GmbH
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 105081
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0196/005
Concerned member states:
  • Ireland
  • Italy
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 15/02/2022
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