Prascend 1 mg tablets for horses
Prascend 1 mg tablets for horses
Authorised
- Pergolide mesilate
Product identification
Medicine name:
Prascend 1 mg tablets for horses
Prascend 1 mg compresse per cavalli non destinati alla produzione di alimenti per il consumo umano
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
Authorised in:
-
Italy
Package description:
- (ID5): 1 Box with 3 Box with 16 Blister (PolyAmide, Aluminium, PolyVinyl Chloride) with 10 Piece (480.0 Piece)
- (ID4): 1 Box with 13 Blister (PolyAmide, Aluminium, PolyVinyl Chloride) with 7 Piece (91.0 Piece)
- (ID3): 1 Box with 1 Blister (Aluminium, PolyVinyl Chloride, PolyAmide) with 160 Piece (160.0 Piece)
- (ID2): 1 Box with 1 Blister (Aluminium, PolyVinyl Chloride, PolyAmide) with 60 Piece (60.0 Piece)
- (ID1): 1 Box with 1 Blister (Aluminium, PolyVinyl Chloride, PolyAmide) with 100 Piece (100.0 Piece)
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
- Boehringer Ingelheim Vetmedica GmbH
- Haupt Pharma Amareg GmbH
Responsible authority:
- Ministry Of Health
Authorisation number:
- 104134
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
Documents
Combined File of all Documents
English (PDF)
Download Published on: 6/08/2024
Italian (PDF)
Published on: 25/09/2023
Updated on: 26/09/2023
