Veterinary Medicines

Dophacyl SB 1000 mg/g, powder for use in drinking water/milk for cattle and pigs

Authorised
  • Sodium salicylate
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Product identification

Medicine name:
Dophacyl SB 1000 mg/g, powder for use in drinking water/milk for cattle and pigs
Dophacyl 1000 mg/g pulver til anvendelse i drikkevand/mælk
Active substance:
  • Sodium salicylate
Target species:
  • Cattle (calf)
  • Pig
Route of administration:
  • In drinking water/milk use

Product details

Active substance and strength:
  • Sodium salicylate
    1000.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Powder for use in drinking water/milk
Withdrawal period by route of administration:
  • In drinking water/milk use
    • Cattle (calf)
      • Meat and offal
        no withdrawal period
    • Pig
      • Meat and offal
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN02BA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • Bucket: white polypropylene square container provided with a polypropylene lid. The bucket contains 1 kg of product.
  • - Securitainer: white cylindrical polypropylene container, covered with a low-density polyethylene lid. The securitainer contains 500 g of product
  • Securitainer: white cylindrical polypropylene container, covered with a low-density polyethylene lid. The securitainer contains 1 kg of product
  • Bucket: white polypropylene square container provided with a polypropylene lid. The bucket contains 5 kg of product.
  • Bucket: white polypropylene square container provided with a polypropylene lid. The bucket contains 2.5 kg of product.

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 B.V.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 67568
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0392/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • Sweden

Documents

Combined File of all Documents

English (PDF)
Published on: 20/09/2023
Updated on: 21/09/2023
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NLV0392001DC_DophacylSB_RMS PuAR_Final.pdf

English (PDF)
Published on: 27/03/2024
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