Pergolide GNRC 1 mg filmomhulde tabletten voor paarden
Pergolide GNRC 1 mg filmomhulde tabletten voor paarden
Authorised
- Pergolide
Product identification
Medicine name:
Pergolide GNRC 1 mg filmomhulde tabletten voor paarden
Active substance:
- Pergolide
Target species:
-
Horse
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Pergolide1.00/milligram(s)1.00Tablet
Pharmaceutical form:
-
Film-coated tablet
Withdrawal period by route of administration:
-
Oral use
-
Horse
-
Not applicableno withdrawal periodNiet goedgekeurd voor gebruik bij paarden die bestemd zijn voor humane consumptie.
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN04BC02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Netherlands
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) 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:
- Medicines Evaluation Board
Authorisation number:
- REG NL 127313
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
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Dutch (PDF)
Published on: 26/02/2024
