Veterinary Medicines

SULFAPREX 250/50 mg/g Premix for medicated feeding stuff for pigs

Authorised
  • Sulfadiazine
  • Trimethoprim
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Product identification

Medicine name:
SULFAPREX 250/50 mg/g Premix for medicated feeding stuff for pigs
SULFAPREX 250/50 mg PREMEZCLA MEDICAMENTOSA PARA PORCINO
Active substance:
  • Sulfadiazine
  • Trimethoprim
Target species:
  • Pig
Route of administration:
  • In-feed use

Product details

Active substance and strength:
  • Sulfadiazine
    250.00
    milligram(s)
    /
    1.00
    gram(s)
  • Trimethoprim
    50.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Premix for medicated feeding stuff
Withdrawal period by route of administration:
  • In-feed use
    • Pig
      • Meat and offal
        5
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01EW10
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Laboratorios Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 2684 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0186/001
Concerned member states:
  • Austria
  • Belgium
  • Hungary
  • Ireland
  • Italy
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 6/04/2023
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Spanish (PDF)
Published on: 17/03/2023
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Package Leaflet

English (PDF)
Published on: 6/04/2023
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Spanish (PDF)
Published on: 17/03/2023
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Labelling

English (PDF)
Published on: 6/04/2023
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Spanish (PDF)
Published on: 17/03/2023
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