Veterinary Medicines

DrySeal intramammary suspension

Authorised
  • Bismuth subnitrate
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Product identification

Medicine name:
DrySeal intramammary suspension
DrySeal, 2,6g, Intramamární suspenze
Active substance:
  • Bismuth subnitrate
Target species:
  • Cattle
Route of administration:
  • Intramammary use

Product details

Active substance and strength:
  • Bismuth subnitrate
    2.60
    gram(s)
    /
    1.00
    Syringe
Pharmaceutical form:
  • Intramammary suspension
Withdrawal period by route of administration:
  • Intramammary use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG52X
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • A 4 g single dose low-density polyethylene intramammary syringe with a smooth, tapered hermetically sealed nozzle with a low-density polyethylene cap and plunger.Carton box of 20 syringes and alcohol disinfectant wipes.
  • A 4 g single dose low-density polyethylene intramammary syringe with a smooth, tapered hermetically sealed nozzle with a low-density polyethylene cap and plunger.Plastic bucket of 144 syringes and alcohol disinfectant wipes.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Univet Limited
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/048/24-C
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0885/001
Concerned member states:
  • Austria
  • Czechia
  • Germany
  • Hungary
  • Italy
  • Poland
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 6/10/2024
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Czech (PDF)
Published on: 17/10/2024
Download

Combined File of all Documents

English (PDF)
Published on: 6/10/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 17/10/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 17/10/2024
Download

ie-puar-mr-iev0885001-dryseal-intramammary-suspension-en.pdf

English (PDF)
Published on: 6/10/2024
Download
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