Veterinary Medicine Information website

Equizol 400 mg gastro-resistant granules for horses

Authorised

Omeprazole

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Product identification

Medicine name:

Equizol 400 mg gastro-resistant granules for horses

Active substance:

Omeprazole

Target species:

Horse

Route of administration:

Oral use

Product details

Active substance and strength:

Omeprazole

80.00

milligram(s)

/

1.00

gram(s)

Pharmaceutical form:

Gastro-resistant granules

Withdrawal period by route of administration:

Oral use
- Horse
  - Meat and offal
    
    2
    
    day
  - Milk
    
    no withdrawal period
    
    Not authorised for use in animals producing milk for human consumption.

Anatomical therapeutic chemical veterinary (ATCvet) codes:

QA02BC01

Legal status of supply:

Veterinary medicinal product subject to veterinary prescription

Authorisation status:

Valid

Authorised in:

Belgium

Available in:

Belgium

Package description:

(ID7) 1000 gram(s): Box (cardboard) with 200 Bag (polyethylene; aluminium; paper) each with 5 gram(s)
(ID6) 560 gram(s): Box (cardboard) with 112 Bag (polyethylene; aluminium; paper) each with 5 gram(s)
(ID5) 500 gram(s): Box (cardboard) with 100 Bag (polyethylene; aluminium; paper) each with 5 gram(s)
(ID4) 420 gram(s): Box (cardboard) with 84 Bag (polyethylene; aluminium; paper) each with 5 gram(s)
(ID3) 280 gram(s): Box (cardboard) with 56 Bag (polyethylene; aluminium; paper) each with 5 gram(s)
(ID2) 140 gram(s): Box (cardboard) with 28 Bag (polyethylene; aluminium; paper) each with 5 gram(s)
(ID1) 70 gram(s): Box (cardboard) with 14 Bag (polyethylene; aluminium; paper) each with 5 gram(s)

Additional information

Entitlement type:

Marketing Authorisation

Legal basis of product authorisation:

Hybrid application (Article 13(3) of Directive No 2001/82/EC)

Marketing authorisation holder:

CP-Pharma Handelsgesellschaft mbH

Marketing authorisation date:

25/07/2018

Manufacturing sites for batch release:

CP-Pharma Handelsgesellschaft mbH

Responsible authority:

Federal Agency For Medicines And Health Products

Authorisation number:

BE-V532577

Date of authorisation status change:

25/07/2018

Reference member state:

Germany

Procedure number:

DE/V/0318/001

Concerned member states:

Austria
Belgium
Czechia
Denmark
Finland
France
Hungary
Ireland
Italy
Netherlands
Norway
Poland
Portugal
Slovakia
Spain
Sweden
United Kingdom (Northern Ireland)

To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.

Other languages (3)

French (PDF)

Published on: 14/01/2026

German (PDF)

Published on: 14/01/2026

Dutch (PDF)

Published on: 14/01/2026

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.

Other languages (3)

French (PDF)

Published on: 14/01/2026

German (PDF)

Published on: 14/01/2026

Dutch (PDF)

Published on: 14/01/2026

Labelling

This document does not exist in this language (English). You can find it in another language below.

Other languages (3)

French (PDF)

Published on: 14/01/2026

German (PDF)

Published on: 14/01/2026

Dutch (PDF)

Published on: 14/01/2026

Combined File of all Documents

English (PDF)

Published on: 5/03/2026

2402376-paren-20190327.rtf

English (RTF)

Published on: 27/01/2026