Veterinary Medicines

Azaporc 40 mg/ml solution for injection for pigs

Authorised
  • Azaperone
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Product identification

Medicine name:
Azaporc 40 mg/ml solution for injection for pigs
Azaporc 40 mg/ml инжекционен разтвор за прасета
Active substance:
  • Azaperone
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Azaperone
    40.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        18
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05AD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Available in:
  • Bulgaria
Package description:
  • (ID1): 1 Box with 1 Vial (Glass) with 100 millilitre(s) (100 millilitre(s))

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:
  • Serumwerk Bernburg AG
Marketing authorisation date:
Manufacturing sites for batch release:
  • Serumwerk Bernburg AG
Responsible authority:
  • Bulgarian Agency For Food Safety
Authorisation number:
  • 0022-3119
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0330/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • France
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 10/08/2022
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Bulgarian (PDF)
Published on: 24/11/2022
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Combined File of all Documents

English (PDF)
Published on: 10/08/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 24/11/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 24/11/2022
Download

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 24/11/2022
Download
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