Veterinary Medicines

Biopronil spot-on 67 mg/0,67 ml Roztwór do nakrapiania dla psów

Authorised
  • Fipronil
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Product identification

Medicine name:
Biopronil spot-on 67 mg/0,67 ml Roztwór do nakrapiania dla psów
Active substance:
  • Fipronil
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Fipronil
    67.00
    milligram(s)
    /
    0.67
    millilitre(s)
Pharmaceutical form:
  • Spot-on solution
Withdrawal period by route of administration:
  • Spot-on use
    • Dog
      • All relevant tissues
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AX15
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Available in:
  • Poland
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Biowet Drwalew Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Drwalewskie Zaklady Przemyslu Bioweterynaryjnego S.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 3214
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Polish (PDF)
Published on: 19/05/2023
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Package Leaflet

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Polish (PDF)
Published on: 19/05/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 19/05/2023
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