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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
Active substance:
  • Bismuth subnitrate, heavy
Target species:
  • Cattle (dry 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 (dry 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:
  • Denmark
Available in:
  • Denmark
Package description:
  • Boxe of 24 syringes
  • Plastic bucket of 120 syringes
  • Boxes of 60 syringes
  • Plastic bucket of 144 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:
  • Danish Medicines Agency
Authorisation number:
  • 34489
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.
Danish (, INTRAMAMMÆR SUSPENSION 2,6 G-DOSIS)
Published on: 7/04/2025
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