Veterinary Medicines

Procactive 300 mg/ml Suspension for injection for cattle, sheep and pigs

Authorised
  • Benzylpenicillin procaine monohydrate
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Product identification

Medicine name:
Procactive 300 mg/ml Suspension for injection for cattle, sheep and pigs
Procactive, 300 mg/ml süstesuspensioon veistele ja sigadele
Active substance:
  • Benzylpenicillin procaine monohydrate
Target species:
  • Cattle
  • Sheep
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Benzylpenicillin procaine monohydrate
    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
    • Sheep
      • Meat and offal
        4
        day
      • Meat and offal
        6
        day
      • Milk
        156
        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:
  • Estonia
Package description:
  • Polyethylene terephthalate (PET) colourless bottles (250 ml) with type I bromobutyl rubber stoppers and flip-off caps.Pack size: Carton box with 12 boxes containing 1 bottle of 250 ml
  • Polyethylene terephthalate (PET) colourless vials (100 ml) with type I bromobutyl rubber stoppers and flip-off caps.Pack size: Carton box with 30 boxes containing 1 vial of 100 ml
  • Polyethylene terephthalate (PET) colourless vials (100 ml) with type I bromobutyl rubber stoppers and flip-off caps.Pack size: Carton box with 10 boxes containing 1 vial of 100 ml
  • Polyethylene terephthalate (PET) colourless bottle (250 ml) with type I bromobutyl rubber stoppers and flip-off caps.Pack size: Carton box with 1 bottle of 250 ml
  • Polyethylene terephthalate (PET) colourless vial (100 ml) with type I bromobutyl rubber stoppers and flip-off caps.Pack size: Carton box with 1 vial of 100 ml

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 Syva S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Syva S.A.U.
Responsible authority:
  • State Agency Of Medicines
Authorisation number:
  • 2159
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0397/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download
Estonian (PDF)
Published on: 11/03/2022
Download
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