Veterinary Medicines

DOMOSEDAN GEL 7.6 mg/ml oromucosal gel

Authorised
  • DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
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Product identification

Medicine name:
DOMOSEDAN GEL 7.6 mg/ml oromucosal gel
Domosedan Vet. 7,6 mg/ml mundhulegel
Active substance:
  • DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
Target species:
  • Horse
Route of administration:
  • Sublingual use

Product details

Active substance and strength:
  • DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
    7.60
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oromucosal gel
Withdrawal period by route of administration:
  • Sublingual use
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • Pre-filled, single-dose syringe enabling doses from 1.0 ml to 3.0 ml packed in outer carton. Pre-filled syringes consist of a syringe barrel (HDPE), cap (LDPE), plunger (HDPE) and a locking ring. Package sizes: 1 x 3.0 ml (1 syringe per carton)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Orion Corporation
Marketing authorisation date:
Manufacturing sites for batch release:
  • Orion Corporation
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 42440
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0218/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download
Danish (, MUNDHULEGEL 7,6 MG-ML)
Published on: 29/06/2023
Download
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