Veterinary Medicines

GIROLAN/APRALAN

Authorised
  • Apramycin sulfate
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Product identification

Medicine name:
GIROLAN/APRALAN
APRALAN SOLUBILE
Active substance:
  • Apramycin sulfate
Target species:
  • Pig (weaned piglet)
  • Rabbit
  • Cattle (pre-ruminant)
  • Chicken (broiler)
Route of administration:
  • In drinking water/milk use

Product details

Active substance and strength:
  • Apramycin sulfate
    552000.00
    international unit(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Powder for use in drinking water/milk
Withdrawal period by route of administration:
  • In drinking water/milk use
    • Pig (weaned piglet)
      • Meat and offal
        0
        day
    • Rabbit
      • Meat and offal
        0
        day
    • Cattle (pre-ruminant)
      • Meat and offal
        28
        day
    • Chicken (broiler)
      • Meat and offal
        0
        day
      • Eggs
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01GB90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • box containing 50 sachets containing 2 x 10e6 UI of apramycin sulfate and 3,6 g of product
  • box containing 50 sachets containing 1 x 10e6 UI of apramycin sulfate and 1,8 g of product
  • bag containing 1.000 x 10e6 UI of apramycin sulfate and 1.812 g of product
  • bottle containing 50 x 10e6 UI of apramycin sulfate and 91 g of product

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Elanco France S.A.S
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 102442
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0321/001
Concerned member states:
  • Denmark
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Portugal
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Italian (PDF)
Published on: 3/06/2022
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