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SPIRAZINA, polvere per soluzione orale per vitelli da latte

Authorised
  • Sulfadimidine
  • Spiramycin
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Product identification

Medicine name:
SPIRAZINA, polvere per soluzione orale per vitelli da latte
Active substance:
  • Sulfadimidine
  • Spiramycin
Target species:
  • Cattle (suckling calf)
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Sulfadimidine
    200.00
    milligram(s)
    /
    1.00
    gram(s)
  • Spiramycin
    384000.00
    international unit(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Oral powder
Withdrawal period by route of administration:
  • Oral use
    • Cattle (suckling calf)
      • Meat and offal
        48
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01RA91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Salute Animale S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Salute Animale S.p.A.
  • Vetem S.p.A.
  • Unione Commerciale Lombarda S.p.A.
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 102700
Date of authorisation status change:

Documents

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Italian (PDF)
Published on: 3/08/2023
Updated on: 4/08/2023
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