Veterinary Medicines

ORBESEAL DRY COW 2.6G INTRAMAMMARY SUSPENSION

Authorised
  • Bismuth subnitrate, heavy
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Product identification

Medicine name:
ORBESEAL DRY COW 2.6G INTRAMAMMARY SUSPENSION
Orbeseal vet. 2,6 g intramammarie, suspensjon til sinkyr
Active substance:
  • Bismuth subnitrate, heavy
Target species:
  • Cattle (cow)
Route of administration:
  • Intramammary use

Product details

Active substance and strength:
  • Bismuth subnitrate, heavy
    2.60
    gram(s)
    /
    1.00
    Syringe
Pharmaceutical form:
  • Intramammary suspension
Withdrawal period by route of administration:
  • Intramammary use
    • Cattle (cow)
      • Meat and offal
        0
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG52X
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Package description:
  • Boxes of 60 syringes
  • Plastic bucket of 120 syringes
  • Boxe of 24 syringes

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:
  • Zoetis Animal Health ApS
Marketing authorisation date:
Manufacturing sites for batch release:
  • Cross Vetpharm Group Limited
  • Haupt Pharma Latina S.r.l.
Responsible authority:
  • Norwegian Medicines Agency
Authorisation number:
  • 02-1548
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0341/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Denmark
  • Finland
  • Germany
  • Greece
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Romania
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 6/06/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 6/06/2023
Download
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