Veterinary Medicines

PROBENCIL 300 mg/ml suspension for injection for cattle and pigs

Authorised
  • Benzylpenicillin procaine
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Product identification

Medicine name:
PROBENCIL 300 mg/ml suspension for injection for cattle and pigs
Probencil 300 mg/ml Zawiesina do wstrzykiwań
Active substance:
  • Benzylpenicillin procaine
Target species:
  • Cattle
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Benzylpenicillin procaine
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        6
        day
      • Meat and offal
        8
        day
      • Milk
        96
        hour
    • Pig
      • Meat and offal
        6
        day
      • Meat and offal
        8
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CE09
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Available in:
  • Poland
Package description:
  • 250 ml colourless polyethylene terephthalate (PET) bottle with type I bromobutyl rubber stopper and flip-off cap.Pack size: Carton box with 1 bottle of 250 ml.
  • 100 ml colourless polyethylene terephthalate (PET) bottle with type I bromobutyl rubber stopper and flip-off cap.Pack size: Carton 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:
  • Mevet S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Syva S.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2873
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0398/001
Concerned member states:
  • Poland
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 19/01/2025
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Polish (PDF)
Published on: 13/03/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 13/03/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 13/03/2025
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Combined File of all Documents

English (PDF)
Published on: 19/01/2025
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ie-puar-mr-iev0398001-probencil-300-mgml-suspension-for-injection-for-ca-en.pdf

English (PDF)
Published on: 25/09/2024
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