Veterinary Medicines

Butox Protect 7.5 mg/ml pour-on suspension for cattle and sheep

Authorised
  • Deltamethrin
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Product identification

Medicine name:
Butox Protect 7.5 mg/ml pour-on suspension for cattle and sheep
Butox Protect 7.5 mg/ml, суспензия за накапване за говеда и овце
Active substance:
  • Deltamethrin
Target species:
  • Cattle
  • Sheep
Route of administration:
  • Pour-on use

Product details

Active substance and strength:
  • Deltamethrin
    7.50
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Pour-on suspension
Withdrawal period by route of administration:
  • Pour-on use
    • Cattle
      • Milk
        0
        day
      • Meat and offal
        18
        day
    • Sheep
      • Milk
        12
        hour
      • Meat and offal
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AC11
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Package description:
  • (ID3): 1 unspecified outer container with 1 Bottle (High Density PolyEthylene) with 2500 millilitre(s) (2500 millilitre(s))
  • (ID2): 1 unspecified outer container with 1 Bottle (High Density PolyEthylene) with 1000 millilitre(s) (1000 millilitre(s))
  • (ID1): 1 unspecified outer container with 1 Bottle (High Density PolyEthylene) with 250 millilitre(s) (250 millilitre(s))

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:
  • Intervet International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet Productions S.A.
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-2482
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0134/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Denmark
  • Finland
  • Greece
  • Luxembourg
  • Netherlands
  • Slovenia
  • Sweden

Documents

Summary of Product Characteristics

English (PDF)
Published on: 14/02/2022
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Bulgarian (PDF)
Published on: 22/03/2024
Download

Combined File of all Documents

English (PDF)
Published on: 24/04/2024
Download

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 22/03/2024
Download
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