Pergosafe 1 mg film-coated tablets for horses
Pergosafe 1 mg film-coated tablets for horses
Authorised
- Pergolide mesilate
Product identification
Medicine name:
Pergosafe 1 mg film-coated tablets for horses
Pergosafe 1 mg film-coated tablets for horses
Active substance:
- Pergolide mesilate
Target species:
-
Horse
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Pergolide mesilate1.31milligram(s)1.00Tablet
Pharmaceutical form:
-
Film-coated tablet
Withdrawal period by route of administration:
-
Oral use
- Horse
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN04BC02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Ireland
Package description:
- PVC-PE-PVDC-aluminium blisters, containing 10 tablets each, in a carton box (160 tablets)
- PVC-PE-PVDC-aluminium blisters, containing 10 tablets each, in a carton box (90 tablets)
- PVC-PE-PVDC-aluminium blisters, containing 10 tablets each, in a carton box (60 tablets)
- PVC-PE-PVDC-aluminium blisters, containing 10 tablets each, in a carton box (30 tablets)
- PVC-PE-PVDC-aluminium blisters, containing 10 tablets each, in a carton box (240 tablets)
- OPA-aluminium-PVC-aluminium blisters, containing 10 tablets each, in a carton box (240 tablets)
- OPA-aluminium-PVC-aluminium blisters, containing 10 tablets each, in a carton box (160 tablets)
- OPA-aluminium-PVC-aluminium blisters, containing 10 tablets each, in a carton box (120 tablets)
- OPA-aluminium-PVC-aluminium blisters, containing 10 tablets each, in a carton box (100 tablets)
- OPA-aluminium-PVC-aluminium blisters, containing 10 tablets each, in a carton box (10 tablets)
- PVC-PE-PVDC-aluminium blisters, containing 10 tablets each, in a carton box (120 tablets)
- PVC-PE-PVDC-aluminium blisters, containing 10 tablets each, in a carton box (100 tablets)
- PVC-PE-PVDC-aluminium blisters, containing 10 tablets each, in a carton box (10 tablets)
- OPA-aluminium-PVC-aluminium blisters, containing 10 tablets each, in a carton box (90 tablets)
- OPA-aluminium-PVC-aluminium blisters, containing 10 tablets each, in a carton box (60 tablets)
- OPA-aluminium-PVC-aluminium blisters, containing 10 tablets each, in a carton box (30 tablets)
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:
- Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Alfasan Nederland B.V.
- Lelypharma B.V.
Responsible authority:
- Health Products Regulatory Authority
Authorisation number:
- VPA10980/042/002
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0357/002
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
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: 28/03/2023
Updated on: 3/09/2023
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