Veterinary Medicines

Fypryst 2.5 mg/ml cutaneous spray, solution for cats and dogs

Authorised
  • Fipronil
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Product identification

Medicine name:
Fypryst 2.5 mg/ml cutaneous spray, solution for cats and dogs
Fypryst 2,5 mg/ml, dermalno pršilo, raztopina za mačke in pse
Active substance:
  • Fipronil
Target species:
  • Cat
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Fipronil
    2.50
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Cutaneous spray, solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AX15
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Available in:
  • Slovenia
Package description:
  • Opaque, white 100 ml high density polyethylene bottle fitted with a pump sprayer capable of delivering 0.5 ml per spray.
  • Opaque, white 500 ml high density polyethylene bottle fitted with a pump sprayer capable of delivering 3.0 ml per spray.
  • Opaque, white 250 ml high density polyethylene bottle fitted with a pump sprayer capable of delivering 1.5 ml per spray.

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/0146/006
Date of authorisation status change:
Reference member state:
  • Hungary
Procedure number:
  • HU/V/0134/001
Concerned member states:
  • Bulgaria
  • Estonia
  • 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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