Veterinary Medicines

Butagran Equi 200 mg/g Oral powder

Authorised
  • Phenylbutazone
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Product identification

Medicine name:
Butagran Equi 200 mg/g Oral powder
Butagran Equi 200 mg/g oralt pulver
Active substance:
  • Phenylbutazone
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Phenylbutazone
    200.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Oral powder
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Meat and offal
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • Butagran Equi 200 mg/g 20 sachets (ALU/LDPE/paper/LDPE) of 5g or. pwdr.
  • Butagran Equi 200 mg/g 100 sachet ((ALU/LDPE/paper/LDPE)) 5 g or. pwdr.)
  • Butagran Equi 200 mg/g 20 sachet (PET/LDPE/ALU/LDPE) 5 g or. pwdr.
  • Butagran Equi 200 mg/g 100 sachet (PET/LDPE/ALU/LDPE) 5 g or. pwdr.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Dopharma Research B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dopharma Research B.V.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 49966
Date of authorisation status change:
Reference member state:
  • Belgium
Procedure number:
  • BE/V/0035/001
Concerned member states:
  • Austria
  • Bulgaria
  • Denmark
  • Estonia
  • Germany
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Spain
  • United Kingdom (Northern Ireland)
Generic of:

Documents

Summary of Product Characteristics

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Danish (PDF)
Published on: 29/06/2023
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