Veterinary Medicines

Ophtocycline 10mg/g eye ointment for horses, dogs and cats

Authorised
  • Chlortetracycline hydrochloride
Download as PDF

Product identification

Medicine name:
Ophtocycline 10mg/g eye ointment for horses, dogs and cats
Ophtaclin vet 10 mg/g augnsmyrsli fyrir hunda, ketti og hesta
Active substance:
  • Chlortetracycline hydrochloride
Target species:
  • Horse
  • Dog
  • Cat
Route of administration:
  • Ocular use

Product details

Active substance and strength:
  • Chlortetracycline hydrochloride
    10.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Eye ointment
Withdrawal period by route of administration:
  • Ocular use
    • Horse
      • Meat and offal
        1
        day
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS01AA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Iceland
Package description:
  • Epoxy resin lacquered aluminium tube with a content of 5 g, with a HDPE cannula and screw cap. One tube in a cardboard box.

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:
  • Le Vet. Beheer B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Icelandic Medicines Agency
Authorisation number:
  • IS/2/17/007/01
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0209/001
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.
Icelandic (PDF)
Published on: 7/04/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Icelandic (PDF)
Published on: 7/04/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."