Veterinary Medicines

Finilac 50 mcg/ml

Authorised
  • Cabergoline
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Product identification

Medicine name:
Finilac 50 mcg/ml
FINILAC 50 mcg/ml solutie orala pentru caini si pisici
Active substance:
  • Cabergoline
Target species:
  • Dog
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Cabergoline
    50.00
    microgram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02CB03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:
  • Cardboard box containing 1 bottle (brown type-III glass, closed by a LDPE conical Luer slip syringe adapter and a HDPE screw cap) filled with 25 ml
  • Cardboard box containing 1 bottle (brown type-III glass, closed by a LDPE conical Luer slip syringe adapter and a HDPE screw cap) filled with 3 ml
  • Cardboard box containing 1 bottle (brown type-III glass, closed by a LDPE conical Luer slip syringe adapter and a HDPE screw cap) filled with 10 ml
  • Cardboard box containing 1 bottle (brown type-III glass, closed by a LDPE conical Luer slip syringe adapter and a HDPE screw cap) filled with 50 ml
  • Cardboard box containing 1 bottle (brown type-III glass, closed by a LDPE conical Luer slip syringe adapter and a HDPE screw cap) filled with 15 ml

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:
  • Le Vet. Beheer B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dreluso Pharmazeutika Dr. Elten und Sohn GmbH
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 200053
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0188/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Romanian (PDF)
Published on: 17/09/2024
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