Veterinary Medicines

Sedanol 40 mg/ml solution for injection for pigs

Authorised
  • Azaperone
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Product identification

Medicine name:
Sedanol 40 mg/ml solution for injection for pigs
Sedanol 40 mg/ml soluzione iniettabile per suini
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:
  • Italy
Package description:
  • (ID2) 100 millilitre(s): unspecified outer container with 1 Vial (Glass) with 100 millilitre(s), closed with Stopper (chlorobutyl rubber`)
  • (ID1) 50 millilitre(s): unspecified outer container with 1 Vial (Glass) with 50 millilitre(s), closed with Stopper (chlorobutyl rubber`)

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:
  • Vetviva Richter GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetviva Richter GmbH
  • Richter Pharma AG
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 105315
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0300/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 5/06/2023
Download
Italian (PDF)
Published on: 16/11/2023
Download
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