Veterinary Medicines

ALFAGLANDIN C 0.250 mg/ml solution for injection for cattle

Authorised
  • Cloprostenol
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Product identification

Medicine name:
ALFAGLANDIN C 0.250 mg/ml solution for injection for cattle
Alfaglandin C 0.25 mg/ml Oplossing voor injectie
Alfaglandin C 0.25 mg/ml Solution injectable
Alfaglandin C 0.25 mg/ml Injektionslösung
Active substance:
  • Cloprostenol
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Cloprostenol
    0.25
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • 28 vials in a polystyrene box. Amber glass, 20 ml, type II vial with bromobutyl rubber stopper and aluminium closure.
  • 1 vial in a carton box. Amber glass, 20 ml, type II vial with bromobutyl rubber stopper and aluminium closure.

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.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V467786
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0146/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Denmark
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Poland
  • Slovenia

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
Download
French (PDF)
Published on: 22/03/2022
Download
German (PDF)
Published on: 22/03/2022
Download
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