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
Prohydol 35 mg/ml Gel voor oraal gebruik
Prohydol 35 mg/ml Gel oral
Prohydol 35 mg/ml Gel zum Einnehmen
Active substance:
- Acepromazine maleate
Target species:
-
Horse
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Acepromazine maleate47.50/milligram(s)1.00millilitre(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:
-
Belgium
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:
- Federal Agency For Medicines And Health Products
Authorisation number:
This information is not available for this product.
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
Summary of Product Characteristics
This document does not exist in this language (English). You can find it
in another language below.
Package Leaflet
This document does not exist in this language (English). You can find it
in another language below.
Labelling
This document does not exist in this language (English). You can find it
in another language below.
