Authorised

Product identification

Medicine name:
Ubrolexin intramammary suspension for lactating dairy cows
Ubrolexin, intramaminė suspensija pieninėms karvėms laktacijos metu
Active substance:
  • Cefalexin monohydrate
  • KANAMYCIN MONOSULPHATE
Target species:
  • Cattle
Route of administration:
  • Intramammary use

Product details

Active substance and strength:
  • Cefalexin monohydrate
    210.36
    milligram(s)
    /
    1.00
    Syringe
  • KANAMYCIN MONOSULPHATE
    120247.00
    international unit(s)
    /
    1.00
    Syringe
Pharmaceutical form:
  • Intramammary suspension
Withdrawal period by route of administration:
  • Intramammary use
    • Cattle
      • Meat and offal
        10
        day
      • Milk
        5
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ51RD01
Legal status of supply:
This information is not available for this product.
Authorisation status:
  • Valid
Authorised in:
  • Lithuania
Package description:
  • Cardboard box with 20 single use intramammary syringes and 20 teat wipes (containing isopropanol 70%). Each 10 g syringe contains 12 ml intramammary suspension and consists of a barrel with plunger and sealed sterile tip, all made of low density polyethylene.
  • Cardboard box with 10 single use intramammary syringes and 10 teat wipes (containing isopropanol 70%). Each 10 g syringe contains 12 ml intramammary suspension and consists of a barrel with plunger and sealed sterile tip, all made of low density polyethylene.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Univet Limited
Responsible authority:
  • SFVS
Authorisation number:
  • LT/2/08/1805/001/002
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0221/001
Concerned member states:
  • Austria
  • Belgium
  • Cyprus
  • Czechia
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
Download

RV1805.pdf

Lithuanian (PDF)
Published on: 27/05/2022
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000053012