Veterinary Medicines

PRIMOPEN 300 mg/ml suspension for injection for cattle, pigs and horses

Authorised
  • Benzylpenicillin procaine monohydrate
Download as PDF

Product identification

Medicine name:
PRIMOPEN 300 mg/ml suspension for injection for cattle, pigs and horses
Primopen 300 mg/ml injektionsvæske, suspension
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
      • Meat and offal
        8
        day
      • Meat and offal
        6
        day
      • Milk
        4
        day
    • Horse
      • Meat and offal
        180
        day
      • Meat and offal
        182
        day
    • Pig
      • Meat and offal
        4
        day
      • Meat and offal
        6
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CE09
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • Type II colourless glass bottle, closed with chlorobutyl rubber stopper (Type I) and flip-off aluminium collar with tamper-evident polypropylene seal, in a cardboard box.Pack-size:1 x 100 ml glass bottle
  • Type II colourless glass bottle, closed with chlorobutyl rubber stopper (Type I) and flip-off aluminium collar with tamper-evident polypropylene seal, in a cardboard box.Pack-size:1 x 250 ml glass bottle
  • Colourless polyethylene terephthalate (PET) bottles, closed with chlorobutyl rubber stopper (Type I) and flip-off aluminium collar with tamper-evident polypropylene seal, in a cardboard boxes.Pack-size:10 x 100 ml PET bottle
  • Colourless polyethylene terephthalate (PET) bottles, closed with chlorobutyl rubber stopper (Type I) and flip-off aluminium collar with tamper-evident polypropylene seal, in a cardboard boxes.Pack-size:30 x 100 ml PET bottle
  • Colourless polyethylene terephthalate (PET) bottles, closed with chlorobutyl rubber stopper (Type I) and flip-off aluminium collar with tamper-evident polypropylene seal, in a cardboard boxes.Pack-size:6 x 250 ml PET bottle
  • Colourless polyethylene terephthalate (PET) bottle, closed with chlorobutyl rubber stopper (Type I) and flip-off aluminium collar with tamper-evident polypropylene seal, in a cardboard box.Pack-size:1 x 100 ml PET bottle
  • Colourless polyethylene terephthalate (PET) bottle, closed with chlorobutyl rubber stopper (Type I) and flip-off aluminium collar with tamper-evident polypropylene seal, in a cardboard box.Pack-size:1 x 250 ml PET bottle

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:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 63269
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0640/001
Concerned member states:
  • Denmark
  • Greece
  • Italy
  • Norway
  • Poland
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 25/09/2024
Download
Danish (PDF)
Published on: 4/11/2024
Download

ie-puar-mr-iev0640001-primopen-300-mgml-suspension-for-injection-for-cat-en.pdf

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