Veterinary Medicines

Prinocate 400 mg/100 mg spot-on solution for extra-large dogs

Authorised
  • Moxidectin
  • Imidacloprid
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Product identification

Medicine name:
Prinocate 400 mg/100 mg spot-on solution for extra-large dogs
Prinocate 400 mg/100 mg διάλυμα για επίχυση σε σημείο για υπερμεγέθεις σκύλους
Active substance:
  • Moxidectin
  • Imidacloprid
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Moxidectin
    100.00
    milligram(s)
    /
    1.00
    Pipette
  • Imidacloprid
    400.00
    milligram(s)
    /
    1.00
    Pipette
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:
  • Greece
Package description:
  • A white polypropylene (PP) unit dose pipette with a closure with a spike composed of high density polyethylene (HDPE) orpolyoxymethylene (POM) or polypropylene (PP) packed into a laminated triplex bag composed of polyester (PETP), aluminium(Al) and low density polyetylene (LDPE).Cardboard box containing 1 pipette.
  • A white polypropylene (PP) unit dose pipette with a closure with a spike composed of high density polyethylene (HDPE) orpolyoxymethylene (POM) or polypropylene (PP) packed into a laminated triplex bag composed of polyester (PETP), aluminium(Al) and low density polyetylene (LDPE).Cardboard box containing 3 pipettes.
  • A white polypropylene (PP) unit dose pipette with a closure with a spike composed of high density polyethylene (HDPE) orpolyoxymethylene (POM) or polypropylene (PP) packed into a laminated triplex bag composed of polyester (PETP), aluminium(Al) and low density polyetylene (LDPE).Cardboard box containing 4 pipettes.
  • A white polypropylene (PP) unit dose pipette with a closure with a spike composed of high density polyethylene (HDPE) orpolyoxymethylene (POM) or polypropylene (PP) packed into a laminated triplex bag composed of polyester (PETP), aluminium(Al) and low density polyetylene (LDPE).Cardboard box containing 6 pipettes.
  • A white polypropylene (PP) unit dose pipette with a closure with a spike composed of high density polyethylene (HDPE) orpolyoxymethylene (POM) or polypropylene (PP) packed into a laminated triplex bag composed of polyester (PETP), aluminium(Al) and low density polyetylene (LDPE).Cardboard box containing 24 pipettes.
  • A white polypropylene (PP) unit dose pipette with a closure with a spike composed of high density polyethylene (HDPE) orpolyoxymethylene (POM) or polypropylene (PP) packed into a laminated triplex bag composed of polyester (PETP), aluminium(Al) and low density polyetylene (LDPE).Cardboard box containing 48 pipettes.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • National Organization For Medicines
Authorisation number:
  • 38183/02-04-2020/K-0240406
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0392/006
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Estonia
  • France
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 23/02/2025
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Greek (PDF)
Published on: 2/10/2025
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Combined File of all Documents

English (PDF)
Published on: 23/02/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Greek (PDF)
Published on: 2/10/2025
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ie-puar-mr-iev0392006-prinocate-400-mg100-mg-spot-on-solution-for-extra--en.pdf

English (PDF)
Published on: 23/02/2025
Download