Veterinary Medicines

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

Authorised
  • ADRENALINE TARTRATE PH. EUR.
  • Procaine hydrochloride
Download as PDF

Product identification

Medicine name:
PRONESTESIC 40 mg/ml + 0.036 mg/ml solution for injection for horses, cattle, swine and sheep
Pronestesic 40 mg/ml + 0,036 mg/ml Injektionslösung für Pferde, Rinder, Schweine und Schafe
Active substance:
  • ADRENALINE TARTRATE PH. EUR.
  • Procaine hydrochloride
Target species:
  • Cattle
  • Sheep
  • Pig
  • Horse
Route of administration:
  • Perineural use
  • Subcutaneous use

Product details

Active substance and strength:
  • ADRENALINE TARTRATE PH. EUR.
    0.04
    milligram(s)
    /
    1.00
    millilitre(s)
  • Procaine hydrochloride
    40.00
    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:
  • Medicinal product on medical prescription for renewable delivery
Authorisation status:
  • Valid
Authorised in:
  • Austria
Available in:
  • Austria
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:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 836934
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

Package Leaflet

English (PDF)
Published on: 25/12/2023
Download
German (PDF)
Published on: 27/04/2021
Download

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
Download
German (PDF)
Published on: 27/04/2021
Download

Labelling

English (PDF)
Published on: 25/12/2023
Download
German (PDF)
Published on: 27/04/2021
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
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."