Veterinary Medicines

Intramar Lacto, 200 mg + 50 mg + 10mg, Intramammary suspension

Authorised
  • Prednisolone
  • Amoxicillin trihydrate
  • Potassium clavulanate
Download as PDF

Product identification

Medicine name:
Intramar Lacto, 200 mg + 50 mg + 10mg, Intramammary suspension
INTRAMAR Lacto 200 mg + 50 mg + 10 mg sospensione intramammaria per bovini
Active substance:
  • Prednisolone
  • Amoxicillin trihydrate
  • Potassium clavulanate
Target species:
  • Cattle (lactating cow)
Route of administration:
  • Intramammary use

Product details

Active substance and strength:
  • Prednisolone
    10.00
    milligram(s)
    /
    1.00
    Applicator
  • Amoxicillin trihydrate
    229.61
    milligram(s)
    /
    1.00
    Applicator
  • Potassium clavulanate
    59.56
    milligram(s)
    /
    1.00
    Applicator
Pharmaceutical form:
  • Intramammary suspension
Withdrawal period by route of administration:
  • Intramammary use
    • Cattle (lactating cow)
      • Meat and offal
        7
        day
      • Milk
        84
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ51RV01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • Plastic (LDPE) Applicator 24 x 1.0 Applicator 24x dezinf. ubrousky
  • Plastic (LDPE) Applicator 24 x 1.0 Applicator bez ubrousků

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:
  • Bioveta a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • European Medicines Agency
Authorisation number:
  • 105794
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0188/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Cyprus
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 18/11/2025
Download