Veterinary Medicines

Dormazolam 5 mg/ml solution for injection for horses

Authorised
  • Midazolam
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Product identification

Medicine name:
Dormazolam 5 mg/ml solution for injection for horses
Dormazolam 5 mg/ml raztopina za injiciranje za konje
Active substance:
  • Midazolam
Target species:
  • Horse
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Midazolam
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CD08
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:
  • Colourless type I glass vials of 50 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.
  • Colourless type I glass vials of 20 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.
  • Colourless type I glass vials of 10 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.
  • Colourless type I glass vials of 5 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.

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:
  • Le Vet. Beheer B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0634/001
Date of authorisation status change:
Reference member state:
  • Portugal
Procedure number:
  • PT/V/0138/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 24/01/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 24/01/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 24/01/2025
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Combined File of all Documents

English (PDF)
Published on: 6/06/2025
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