Veterinary Medicines

Procipen 300 mg/ml suspension for injection for cattle, sheep and pigs

Authorised
  • Benzylpenicillin procaine
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Product identification

Medicine name:
Procipen 300 mg/ml suspension for injection for cattle, sheep and pigs
PROCIPEN 300 mg/mL SUSPENSION INYECTABLE PARA BOVINO OVINO Y PORCINO
Active substance:
  • Benzylpenicillin procaine
Target species:
  • Cattle
  • Sheep
  • 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
        10
        day
      • Meat and offal
        12
        day
      • Milk
        108
        hour
    • Sheep
      • Meat and offal
        4
        day
      • Meat and offal
        6
        day
    • Pig
      • Meat and offal
        7
        day
      • Meat and offal
        9
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CE09
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • The product is packaged in clear 100 ml Type I and 250 ml clear Type III glass vials sealed with red or grey, siliconised bromobutyl rubber stoppers and aluminium overseal, containing a sterile aqueous suspension. Carton box with 48 boxes containing 1 vial of 250 mlThe vials are colourless.
  • The product is packaged in clear 100 ml Type I glass vials sealed with red or grey, siliconised bromobutyl rubber stoppers and aluminium overseal, containing a sterile aqueous suspension. Carton box with 48 boxes containing 1 vial of 100 mlThe vials are colourless.
  • The product is packaged in clear 100 ml Type I and 250 ml clear Type III glass vials sealed with red or grey, siliconised bromobutyl rubber stoppers and aluminium overseal, containing a sterile aqueous suspension. 12 shrink-wrapped boxes containing 1 vial of 250 mlThe vials are colourless.
  • The product is packaged in clear 100 ml Type I glass vials sealed with red or grey, siliconised bromobutyl rubber stoppers and aluminium overseal, containing a sterile aqueous suspension. 12 shrink-wrapped boxes containing 1 vial of 100 mlThe vials are colourless.
  • The product is packaged in clear 100 ml Type I and 250 ml clear Type III glass vial sealed with red or grey, siliconised bromobutyl rubber stopper and aluminium overseal, containing a sterile aqueous suspension. Carton box with 1 vial of 250 mlThe vial is colourless.
  • The product is packaged in clear 100 ml Type I glass vial sealed with red or grey, siliconised bromobutyl rubber stopper and aluminium overseal, containing a sterile aqueous suspension. Carton box with 1 vial of 100 mlThe vial is colourless.

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:
  • Bimeda Animal Health Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bimeda Animal Health Limited
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 4022 ESP
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0416/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
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Spanish (PDF)
Published on: 13/09/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 13/09/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 13/09/2024
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ie-puar-mr-iev0416001-procipen-300-mgml-suspension-for-injection-for-cat-en.pdf

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