Veterinary Medicines

Presedine 10 mg/ml solution for injection for horses and cattle

Authorised
  • Dexmedetomidine hydrochloride
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Product identification

Medicine name:
Presedine 10 mg/ml solution for injection for horses and cattle
Active substance:
  • Dexmedetomidine hydrochloride
Target species:
  • Horse
  • Cattle
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Dexmedetomidine hydrochloride
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Horse
      • Meat and offal
        2
        day
    • Cattle
      • Meat and offal
        2
        day
      • Milk
        12
        hour
  • Intravenous use
    • Horse
      • Meat and offal
        2
        day
    • Cattle
      • Meat and offal
        2
        day
      • Milk
        12
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Package description:
  • Cardboard box with one type I clear glass vial containing 20 mL of product (in a 20 mL sized vial), with coated grey bromobutyl rubber stopper and aluminium cap.
  • Cardboard box with one type I clear glass vial containing 10 mL of product (in a 10 mL sized vial) with coated grey bromobutyl rubber stopper and aluminium cap.
  • Cardboard box with one type I clear glass vial containing 5 mL of product (in a 10 mL sized vial) with coated grey bromobutyl rubber stopper and aluminium cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alfasan Nederland B.V.
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 22-14738
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0385/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
Generic of:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 18/08/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 3/10/2024
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Combined File of all Documents

English (PDF)
Published on: 28/07/2023
Download
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