Veterinary Medicines

FYPRYST pro psy, 402mg, Spot-on solution

Authorised
  • Fipronil
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Product identification

Medicine name:
FYPRYST pro psy, 402mg, Spot-on solution
FYPRYST 402 mg kožne kapljice, raztopina za pse
Active substance:
  • Fipronil
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Fipronil
    402.00
    milligram(s)
    /
    1.00
    Pipette
Pharmaceutical form:
  • Spot-on solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AX15
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:
  • Plastic Pipette 20 x 1.0 Pipette
  • Plastic Pipette 10 x 1.0 Pipette
  • Plastic Pipette 6 x 1.0 Pipette
  • Plastic Pipette 1 x 1.0 Pipette
  • Plastic Pipette 3 x 1.0 Pipette

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:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • DC/V/0146/005
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0107/005
Concerned member states:
  • Bulgaria
  • Estonia
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Slovakia
  • Slovenia

Documents

Summary of Product Characteristics

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Slovenian (PDF)
Published on: 2/03/2022
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Labelling

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Slovenian (PDF)
Published on: 2/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 2/03/2022
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