Veterinary Medicines

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

Authorised
  • Chlortetracycline hydrochloride
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Product identification

Medicine name:
Ophtocycline 10mg/g eye ointment for horses, dogs and cats
Ophtocycline 10 mg/g Oogzalf
Ophtocycline 10 mg/g Pommade ophtalmique
Ophtocycline 10 mg/g Augensalbe
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:
  • Belgium
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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V515102
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

Combined File of all Documents

English (PDF)
Published on: 13/07/2022
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 3/11/2022
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French (PDF)
Published on: 3/11/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 3/11/2022
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French (PDF)
Published on: 3/11/2022
Download
German (PDF)
Published on: 3/11/2022
Download

Final PUAR Opthcocyline NLV0209001DC clean.pdf

English (PDF)
Published on: 13/07/2022
Download
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