Veterinary Medicines

PRONESTESIC 40 mg/ml + 0.036 mg/ml solution for injection for horses, cattle, swine and sheep

Authorised
  • Procaine hydrochloride
  • ADRENALINE TARTRATE PH. EUR.
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Product identification

Medicine name:
PRONESTESIC 40 mg/ml + 0.036 mg/ml solution for injection for horses, cattle, swine and sheep
Pronestesic vet 40 mg/ml + 0,036 mg/ml stungulyf, lausn handa hestum, nautgripum, svínum og sauðfé
Active substance:
  • Procaine hydrochloride
  • ADRENALINE TARTRATE PH. EUR.
Target species:
  • Cattle
  • Sheep
  • Pig
  • Horse
Route of administration:
  • Perineural use
  • Subcutaneous use

Product details

Active substance and strength:
  • Procaine hydrochloride
    40.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • ADRENALINE TARTRATE PH. EUR.
    0.04
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Perineural use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Pig
      • Meat and offal
        0
        day
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Pig
      • Meat and offal
        0
        day
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN01BA52
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Iceland
Package description:
  • box containing 10 vials of 100 ml
  • box containing 1 vial of 250 ml
  • box containing 1 vial of 100 ml
  • box containing 1 vial of 50 ml

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:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • Icelandic Medicines Agency
Authorisation number:
  • IS/2/16/001/01
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0238/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
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Package Leaflet

English (PDF)
Published on: 25/12/2023
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Labelling

English (PDF)
Published on: 25/12/2023
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
Download

eu-PUAR-esv0238001-dcp-pronestesic-40-mg-ml-+-0.036-mg-ml-solution-for-injection-for-horses--cattle--swine-and-sheep-en.pdf

English (PDF)
Published on: 22/12/2023
Download