Veterinary Medicines

Dexdormostart 0.5 mg/ml solution for injection for dogs and cats

Authorised
  • Dexmedetomidine hydrochloride
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Product identification

Medicine name:
Dexdormostart 0.5 mg/ml solution for injection for dogs and cats
Dexdormostart Vet 0,5 mg/ml injektionsvätska, lösning för hund och katt
Active substance:
  • Dexmedetomidine hydrochloride
Target species:
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Dexmedetomidine hydrochloride
    0.50
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM18
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Sweden
Package description:

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:
  • Swedish Medical Products Agency
Authorisation number:
  • 63825
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0400/001
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.
Swedish (PDF)
Published on: 8/11/2023
Updated on: 13/11/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 15/10/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 8/11/2023
Updated on: 13/11/2023
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Combined File of all Documents

English (PDF)
Published on: 14/12/2023
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PuAR Dexdormostart NL-V-0400-001-DC.pdf

English (PDF)
Published on: 24/11/2023
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