Veterinary Medicines

Laxatract 667 mg/ml oral solution

Authorised
  • LACTULOSE, LIQUID
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Product identification

Medicine name:
Laxatract 667 mg/ml oral solution
Laxatract, 667mg/ml, Perorální roztok
Active substance:
  • LACTULOSE, LIQUID
Target species:
  • Dog
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • LACTULOSE, LIQUID
    667.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Syrup
Withdrawal period by route of administration:
  • Oral use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA06AD11
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • HDPE bottle closed with a (LDPE) syringe inlay and a (HDPE) cap. Cardboard box of 1 bottle of 50 ml with a 5ml oral syringe.
  • HDPE bottle closed with a (LDPE) syringe inlay and a (HDPE) cap. Cardboard box of 1 bottle of 125 ml with a 5ml oral syringe.
  • HDPE bottle closed with a (LDPE) syringe inlay and a cap (PP). Cardboard box of 1 bottle of 325 ml with a 10ml oral syringe.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Feramed B.V.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/069/19-C
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0241/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • 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.
Czech (PDF)
Published on: 25/10/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 25/10/2022
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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: 25/10/2022
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