Veterinary Medicine Information website

Cubarmix Equi 400 mg/g and 80 mg/g oral powder for horses

Authorised
  • Sulfadiazine
  • Trimethoprim
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Product identification

Medicine name:
Cubarmix Equi 400 mg/g and 80 mg/g oral powder for horses
Active substance:
  • Sulfadiazine
  • Trimethoprim
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Sulfadiazine
    400.00
    milligram(s)
    /
    1.00
    gram(s)
  • Trimethoprim
    80.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Oral powder
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Meat and offal
        6
        month
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01EW10
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:
  • White cylindrical polypropylene container, covered with a low density polyethylene lid containing 500g of oral powder.
  • White cylindrical polypropylene container, covered with a low density polyethylene lid containing 800g of oral powder.
  • Heat-sealed, white coloured, 4-layer sachet containing 12.5 g of oral powder. 15 sachets per pack.
  • Heat-sealed, white coloured, 4-layer sachet containing 12.5 g of oral powder. 100 sachets per pack
  • Heat-sealed, white coloured, 4-layer sachet containing 37.5 g of oral powder. 5 sachets per pack
  • Heat-sealed, white coloured, 4-layer sachet containing 37.5 g of oral powder. 10 sachets per pack
  • Heat-sealed, white coloured, 4-layer sachet containing 37.5 g of oral powder. 100 sachets per pack
  • Heat-sealed, white coloured, 4-layer sachet containing 50 g of oral powder. 5 sachets per pack
  • Heat-sealed, white coloured, 4-layer sachet containing 50 g of oral powder. 10 sachets per pack
  • Heat-sealed, white coloured, 4-layer sachet containing 50 g of oral powder. 100 sachets per pack

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Dopharma Research B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dopharma B.V.
  • Dopharma France
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 260020
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0673/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Romania
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 15/02/2026
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Romanian (PDF)
Published on: 10/02/2026
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Summary of Product Characteristics

English (PDF)
Published on: 15/02/2026
Download

ie-puar-mr-iev0673001-cubarmix-equi-400-mgg-and-80-mgg-oral-powder-for-h-en.pdf

English (PDF)
Published on: 15/02/2026
Download