Product identification
Medicine name:
Prascend 1 mg tablets for horses
Active substance:
- Pergolide mesilate
Target species:
-
Horse (non food-producing)
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Pergolide mesilate1.31/milligram(s)1.00Tablet
Pharmaceutical form:
-
Tablet
Withdrawal period by route of administration:
-
Oral use
-
Horse (non food-producing)
-
Meat and offalno withdrawal periodNot 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.
-
Milkno withdrawal periodNot 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
Package description:
- (ID1) 100 Tablet: Box (cardboard) with 1 Blister (aluminium; polyvinyl chloride; nylon) with 100 Tablet
- (ID2) 60 Tablet: Box (cardboard) with 1 Blister (aluminium; polyvinyl chloride; nylon) with 60 Tablet
- (ID3) 160 Tablet: Box (cardboard) with 1 Blister (aluminium; polyvinyl chloride; nylon) with 160 Tablet
- (ID4) 91 Tablet: Box (cardboard) with 13 Blister (nylon; aluminium; polyvinyl chloride) each with 7 Tablet, closed with Foil (vinyl, aluminium)
- (ID5) 480 Tablet: Box (cardboard) with 3 Box (cardboard) each with 16 Blister (nylon; aluminium; polyvinyl chloride) each with 10 Tablet, closed with Foil (vinyl, aluminium)
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Manufacturing sites for batch release:
- Boehringer Ingelheim Vetmedica GmbH
- Haupt Pharma Amareg GmbH
Authorisation number:
- VPA10454/011/001
Date of authorisation status change:
Reference member state:
-
Germany
Procedure number:
- DE/V/0130/001
Concerned member states:
-
Austria
-
Belgium
-
Denmark
-
Finland
-
France
-
Iceland
-
Ireland
-
Italy
-
Luxembourg
-
Netherlands
-
Norway
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet