Veterinary Medicines

Procapen, 300 mg/ml, Suspension for injection for cattle, pigs and horses

Authorised
  • Benzylpenicillin procaine monohydrate
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Product identification

Medicine name:
Procapen, 300 mg/ml, Suspension for injection for cattle, pigs and horses
Procapen, 300mg/ml, Injekční suspenze
Active substance:
  • Benzylpenicillin procaine monohydrate
Target species:
  • Cattle
  • Horse
  • 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
      • Milk
        6
        day
      • Meat and offal
        14
        day
      • Meat and offal
        16
        day
    • Horse
      • Milk
        no withdrawal period
      • Meat and offal
        14
        day
      • Meat and offal
        16
        day
    • Pig
      • Meat and offal
        15
        day
      • Meat and offal
        17
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CE09
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • (ID8) 3000 millilitre(s): Box (Cardboard) with 12 Vial (Polypropylen) each with 250 millilitre(s), closed with Stopfen (bromobutyl rubber`)
  • (ID7) 3000 millilitre(s): Box (Cardboard) with 12 Vial (Glass) each with 250 millilitre(s), closed with Stopfen (bromobutyl rubber`)
  • (ID6) 250 millilitre(s): Box (Cardboard) with 1 Vial (Polypropylen) with 250 millilitre(s), closed with Stopfen (bromobutyl rubber`)
  • (ID5) 250 millilitre(s): Box (Cardboard) with 1 Vial (Glass) with 250 millilitre(s), closed with Stopfen (bromobutyl rubber`)
  • (ID4) 1200 millilitre(s): Box (Cardboard) with 12 Vial (Polypropylen) each with 100 millilitre(s), closed with Stopfen (bromobutyl rubber`)
  • (ID3) 100 millilitre(s): Box (Cardboard) with 1 Vial (Polypropylen) with 100 millilitre(s), closed with Stopfen (bromobutyl rubber`)
  • (ID2) 1200 millilitre(s): Box (Cardboard) with 12 Vial (Glass) each with 100 millilitre(s), closed with Stopfen (bromobutyl rubber`)
  • (ID1) 100 millilitre(s): Box (Cardboard) with 1 Vial (Glass) with 100 millilitre(s), closed with Stopfen (bromobutyl rubber`)

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:
  • aniMedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • aniMedica GmbH
  • Industrial Veterinaria S.A.
  • aniMedica Herstellungs GmbH
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/042/19-C
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0126/001
Concerned member states:
  • Austria
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Malta
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 14/02/2022
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Czech (PDF)
Published on: 27/11/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 27/11/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 27/11/2024
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Combined File of all Documents

English (PDF)
Published on: 2/10/2024
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