Relaquine 35 mg/ml Oral Gel for Horses
Relaquine 35 mg/ml Oral Gel for Horses
Authorised
- Acepromazine maleate
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 maleate47.50milligram(s)1.00millilitre(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 PRODUCTEN 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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
English (PDF)
Download Published on: 13/06/2024
How useful was this page?: