Veterinary Medicines

Denagard vet 200 mg/ml injeksjonsvæske

Authorised
  • Tiamulin hydrogen fumarate
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Product identification

Medicine name:
Denagard vet 200 mg/ml injeksjonsvæske
Active substance:
  • Tiamulin hydrogen fumarate
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Tiamulin hydrogen fumarate
    200.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        22
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01XQ01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Available in:
  • Norway
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Elanco France S.A.S.
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 7236
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Norwegian (PDF)
Published on: 14/05/2025
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Package Leaflet

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Norwegian (PDF)
Published on: 14/05/2025
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Labelling

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Norwegian (PDF)
Published on: 14/05/2025
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