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
Relaquine 35 mg/ml Oral Gel for Horses
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
Withdrawal period by route of administration:
  • Oral use
    • Horse
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05AA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • United Kingdom (Northern Ireland)
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.

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 Produkten B.V.
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • Vm 56190/3001
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
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."