Veterinary Medicines

Alfamed Fipronil 402 mg 100 mg/ml Spot-on solution

Authorised
  • Fipronil
Download as PDF

Product identification

Medicine name:
FIPRALONE 402 mg Spot-on solution for very large dogs
Alfamed Fipronil 402 mg 100 mg/ml Spot-on solution
Alfamed Fipronil 402 mg 100 mg/ml Spot-on oplossing
Alfamed Fipronil 402 mg 100 mg/ml Solution pour spot-on
Alfamed Fipronil 402 mg 100 mg/ml Lösung zum Auftropfen
Active substance:
  • Fipronil
Target species:
  • Dog
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Fipronil
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Spot-on solution
Withdrawal period by route of administration:
  • Spot-on use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AX15
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • White multi-layer plastic single-dose pipettes containing an extractible volume of 4.02 ml. The internal layers in contact with the product are made of polyacrylonitrile-methacrylate. The white external complex is composed of polypropylene/ cyclic olefine copolymer/ polypropylene. Boxes of 1, 2, 3, 4, 6, 8, 12, 24, 30, 60, 90 or 150 pipettes. The boxes contain pipettes either with or without an individual blister for each pipette.
  • White multi-layer plastic single-dose pipettes containing an extractible volume of 4.02 ml. The internal layers in contact with the product are made of polyacrylonitrile-methacrylate. The white external complex is composed of polypropylene/ cyclic olefine copolymer/ polypropylene. Boxes of 1, 2, 3, 4, 6, 8, 12, 24, 30, 60, 90 or 150 pipettes. The boxes contain pipettes either with or without an individual blister for each pipette.
  • White multi-layer plastic single-dose pipettes containing an extractible volume of 4.02 ml. The internal layers in contact with the product are made of polyacrylonitrile-methacrylate. The white external complex is composed of polypropylene/ cyclic olefine copolymer/ polypropylene. Boxes of 1, 2, 3, 4, 6, 8, 12, 24, 30, 60, 90 or 150 pipettes. The boxes contain pipettes either with or without an individual blister for each pipette.
  • White multi-layer plastic single-dose pipettes containing an extractible volume of 4.02 ml. The internal layers in contact with the product are made of polyacrylonitrile-methacrylate. The white external complex is composed of polypropylene/ cyclic olefine copolymer/ polypropylene. Boxes of 1, 2, 3, 4, 6, 8, 12, 24, 30, 60, 90 or 150 pipettes. The boxes contain pipettes either with or without an individual blister for each pipette.
  • White multi-layer plastic single-dose pipettes containing an extractible volume of 4.02 ml. The internal layers in contact with the product are made of polyacrylonitrile-methacrylate. The white external complex is composed of polypropylene/ cyclic olefine copolymer/ polypropylene. Boxes of 1, 2, 3, 4, 6, 8, 12, 24, 30, 60, 90 or 150 pipettes. The boxes contain pipettes either with or without an individual blister for each pipette.
  • White multi-layer plastic single-dose pipettes containing an extractible volume of 4.02 ml. The internal layers in contact with the product are made of polyacrylonitrile-methacrylate. The white external complex is composed of polypropylene/ cyclic olefine copolymer/ polypropylene. Boxes of 1, 2, 3, 4, 6, 8, 12, 24, 30, 60, 90 or 150 pipettes. The boxes contain pipettes either with or without an individual blister for each pipette.
  • White multi-layer plastic single-dose pipettes containing an extractible volume of 4.02 ml. The internal layers in contact with the product are made of polyacrylonitrile-methacrylate. The white external complex is composed of polypropylene/ cyclic olefine copolymer/ polypropylene. Boxes of 1, 2, 3, 4, 6, 8, 12, 24, 30, 60, 90 or 150 pipettes. The boxes contain pipettes either with or without an individual blister for each pipette.
  • White multi-layer plastic single-dose pipettes containing an extractible volume of 4.02 ml. The internal layers in contact with the product are made of polyacrylonitrile-methacrylate. The white external complex is composed of polypropylene/ cyclic olefine copolymer/ polypropylene. Boxes of 1, 2, 3, 4, 6, 8, 12, 24, 30, 60, 90 or 150 pipettes. The boxes contain pipettes either with or without an individual blister for each pipette.
  • White multi-layer plastic single-dose pipettes containing an extractible volume of 4.02 ml. The internal layers in contact with the product are made of polyacrylonitrile-methacrylate. The white external complex is composed of polypropylene/ cyclic olefine copolymer/ polypropylene. Boxes of 1, 2, 3, 4, 6, 8, 12, 24, 30, 60, 90 or 150 pipettes. The boxes contain pipettes either with or without an individual blister for each pipette.
  • White multi-layer plastic single-dose pipettes containing an extractible volume of 4.02 ml. The internal layers in contact with the product are made of polyacrylonitrile-methacrylate. The white external complex is composed of polypropylene/ cyclic olefine copolymer/ polypropylene. Boxes of 1, 2, 3, 4, 6, 8, 12, 24, 30, 60, 90 or 150 pipettes. The boxes contain pipettes either with or without an individual blister for each pipette.
  • White multi-layer plastic single-dose pipettes containing an extractible volume of 4.02 ml. The internal layers in contact with the product are made of polyacrylonitrile-methacrylate. The white external complex is composed of polypropylene/ cyclic olefine copolymer/ polypropylene. Boxes of 1, 2, 3, 4, 6, 8, 12, 24, 30, 60, 90 or 150 pipettes. The boxes contain pipettes either with or without an individual blister for each pipette.
  • White multi-layer plastic single-dose pipettes containing an extractible volume of 4.02 ml. The internal layers in contact with the product are made of polyacrylonitrile-methacrylate. The white external complex is composed of polypropylene/ cyclic olefine copolymer/ polypropylene. Boxes of 1, 2, 3, 4, 6, 8, 12, 24, 30, 60, 90 or 150 pipettes. The boxes contain pipettes either with or without an individual blister for each pipette.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic (abridged application) - art 13(1)
Marketing authorisation holder:
  • Alfamed
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alfamed
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V421102
Date of authorisation status change:
Reference member state:
  • Hungary
Procedure number:
  • HU/V/0138/001-006
Concerned member states:
  • Belgium
  • Romania
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
Download
French (PDF)
Published on: 22/03/2022
Download
German (PDF)
Published on: 22/03/2022
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
Download
French (PDF)
Published on: 22/03/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."