600000984127

Product identification

Medicine name:

Prasequine 1 mg tablets for horses

Active substance:

Pergolide

Target species:

Horse (non food-producing)

Route of administration:

Oral use

Product details

Active substance and strength:

Pergolide

1.00

milligram(s)

/

1.00

Tablet

Pharmaceutical form:

Tablet

Withdrawal period by route of administration:

Oral use
- Horse (non food-producing)
  - Not applicable
    
    no withdrawal period
    
    Not authorised for use in horses intended for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation. Not authorised for use in mares producing milk for human consumption.

Anatomical therapeutic chemical veterinary (ATCvet) codes:

QN04BC02

Legal status of supply:

Veterinary medicinal product subject to veterinary prescription

Authorisation status:

Valid

Authorised in:

Hungary

Package description:

Carton box containing 13 OPA/aluminium/PVC-aluminium blisters, containing 7 tablets each
Carton box containing 24 OPA/aluminium/PVC-aluminium blisters, containing 10 tablets each
Carton box containing 16 OPA/aluminium/PVC-aluminium blisters, containing 10 tablets each
Carton box containing 10 OPA/aluminium/PVC-aluminium blisters, containing 10 tablets each
Carton box containing 6 OPA/aluminium/PVC-aluminium blisters, containing 10 tablets each

Additional information

Entitlement type:

Marketing Authorisation

Legal basis of product authorisation:

Generic (abridged application) - art 13(1)

Marketing authorisation holder:

CP-Pharma Handelsgesellschaft mbH

Marketing authorisation date:

11/07/2023

Manufacturing sites for batch release:

CP-Pharma Handelsgesellschaft mbH

Responsible authority:

Directorate Of Veterinary Medicinal Products

Authorisation number:

4374/X/23 NÉBIH ÁTI

Date of authorisation status change:

11/07/2023

Reference member state:

Netherlands

Procedure number:

NL/V/0368/001

Concerned member states:

Austria
Belgium
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
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

Summary of Product Characteristics

English (PDF)

Published on: 9/05/2023

Updated on: 10/05/2023

Download

Package Leaflet and Labelling