Veterinary Medicines

Relaquine 35 mg/ml oral gel for horses

Authorised
  • Acepromazine maleate
Download as PDF

Product identification

Medicine name:
Relaquine 35 mg/ml oral gel for horses
Plegicil Vet - Oralgel - 35 mg/ml
Active substance:
  • Acepromazine maleate
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Acepromazine maleate
    47.50
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral gel
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05AA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Package description:
  • 9 ml gel in a amber Type III glass bottle of 10 ml fitted with syringe adaptors and HDPE/LDPE CRC closure
  • 48 ml gel in a amber Type III glass bottle of 50 ml fitted with syringe adaptors and HDPE/LDPE CRC closure
  • 28 ml gel in a amber Type III glass bottle of 30 ml fitted with syringe adaptors and HDPE/LDPE CRC closure
  • 15 ml gel in a white, high-density polyethylene syringe barrel and a white, low-density polyethylene syringe plunger closed with a white, high-density polyethylene, push-fit cap.
  • 14 ml gel in a amber Type III glass bottle of 15 ml fitted with syringe adaptors and HDPE/LDPE CRC closure
  • 18 ml gel in a amber Type III glass bottle of 20 ml fitted with syringe adaptors and HDPE/LDPE CRC closure
  • 10 ml gel in a white, high-density polyethylene syringe barrel and a white, low-density polyethylene syringe plunger closed with a white, high-density polyethylene, push-fit cap.
  • 10 ml gel in white, linear low-density polyethylene syringe closed with a linear low-density polyethylene, push-fit cap.
  • 15 ml gel in white, linear low-density polyethylene syringe closed with a linear low-density polyethylene, push-fit cap.

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:
  • Floris Holding B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Floris Veterinaire Producten B.V.
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 20-13441
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0303/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Norway
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 13/06/2024
Download

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: 13/08/2024
Updated on: 14/08/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 13/08/2024
Updated on: 14/08/2024
Download