Veterinary Medicines

FIPRALONE 268 mg Spot-on solution for large dogs

Authorised
  • Fipronil
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Product identification

Medicine name:
FIPRALONE 268 mg Spot-on solution for large dogs
FIPRALONE 268 mg soluție spot-on pentru câini de talie mare
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 not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:
  • White multi-layer plastic single-dose pipettes containing an extractible volume of 2.68 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 2.68 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 2.68 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 2.68 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 2.68 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 2.68 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 2.68 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 2.68 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 2.68 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 2.68 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 2.68 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 2.68 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:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 180012
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

Summary of Product Characteristics

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Romanian (PDF)
Published on: 22/02/2022
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