Veterinary Medicines

Azaporc 40 mg/ml solution for injection for pigs

Authorised
  • Azaperone
Download as PDF

Product identification

Medicine name:
Azaporc 40 mg/ml solution for injection for pigs
Azaporc 40 mg/ml oplossing voor injectie voor varkens
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:
  • Netherlands
Available in:
  • Netherlands
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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 127527
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
Download

Combined File of all Documents

English (PDF)
Published on: 10/08/2022
Download
Dutch (PDF)
Published on: 23/08/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."