Veterinary Medicines

CENSULFATRIM 200 mg/ml + 40 mg/ml solution for injection

Authorised
  • Trimethoprim
  • Sulfadiazine
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Product identification

Medicine name:
CENSULFATRIM 200 mg/ml + 40 mg/ml solution for injection
Neuton Vet 200 mg/ml + 40 mg/ml injektionsvätska, lösning
Active substance:
  • Trimethoprim
  • Sulfadiazine
Target species:
  • Cattle
  • Pig
  • Horse
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Trimethoprim
    40.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Sulfadiazine
    200.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        12
        day
    • Pig
      • Meat and offal
        20
        day
    • Cattle
      • Milk
        48
        hour
  • Intravenous use
    • Cattle
      • Meat and offal
        12
        day
    • Horse
      • Meat and offal
        28
        day
    • Pig
      • Meat and offal
        20
        day
    • Cattle
      • Milk
        48
        hour
    • Horse
      • Milk
        no withdrawal period
  • Subcutaneous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01EW10
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Sweden
Package description:
  • Box with 10 vials of 250 ml
  • Box with 10 vials of 100 ml
  • Box with 1 vial of 250 ml
  • Box with 1 vial of 100 ml

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:
  • Cenavisa S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Cenavisa S.L.
Responsible authority:
  • Swedish Medical Products Agency
Authorisation number:
  • 64058
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0381/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Romania
  • Sweden

Documents

Summary of Product Characteristics

English (PDF)
Published on: 5/04/2023
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Swedish (PDF)
Published on: 9/01/2024
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Package Leaflet

English (PDF)
Published on: 5/04/2023
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Swedish (PDF)
Published on: 20/09/2024
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Labelling

English (PDF)
Published on: 5/04/2023
Download
Swedish (PDF)
Published on: 9/01/2024
Download
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