Ulcergold 370 mg/g Oral Paste for Horses
Ulcergold 370 mg/g Oral Paste for Horses
Authorised
- Omeprazole
Product identification
Medicine name:
Peptizole 370 mg/g Oral Paste for Horses
Ulcergold 370 mg/g Oral Paste for Horses
Active substance:
- Omeprazole
Target species:
-
Horse
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Omeprazole370.00milligram(s)1.00gram(s)
Pharmaceutical form:
-
Oral paste
Withdrawal period by route of administration:
-
Oral use
- Horse
-
Meat and offal1day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QA02BC01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
United Kingdom (Northern Ireland)
Package description:
- Immediate package Immediate packaging: 7 ml oral syringe containing 7.57 g of paste composed of polyethylene barrel, plunger and end cap, with polypropylene dosing rings. Outer package and sales presentations - Bucket of 72 oral syringes
- Immediate package Immediate packaging: 7 ml oral syringe containing 7.57 g of paste composed of polyethylene barrel, plunger and end cap, with polypropylene dosing rings. Outer package and sales presentations - Carton box of 7 oral syringes
- Immediate package Immediate packaging: 7 ml oral syringe containing 7.57 g of paste composed of polyethylene barrel, plunger and end cap, with polypropylene dosing rings. Outer package and sales presentations - Carton box of 1 oral syringe
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:
- Norbrook Laboratories Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Norbrook Laboratories Limited
- Norbrook Manufacturing Limited
Responsible authority:
- The Veterinary Medicines Directorate
Authorisation number:
- Vm 02000/4390
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0307/001
Concerned member states:
-
Austria
-
Belgium
-
Czechia
-
Estonia
-
Finland
-
France
-
Hungary
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Malta
-
Netherlands
-
Poland
-
Portugal
-
Slovakia
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 11/02/2022
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