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 suspensie voor injectie voor runderen, schapen en varkens
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:
  • Netherlands
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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 126684
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

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 13/06/2024
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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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