Veterinary Medicines

Otimectin vet. 1 mg/g ear gel for cats

Authorised
  • Ivermectin
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Product identification

Medicine name:
Otimectin vet. 1 mg/g ear gel for cats
Otimectin vet. 1 mg/ g Żel do uszu
Active substance:
  • Ivermectin
Target species:
  • Cat
Route of administration:
  • Auricular use

Product details

Active substance and strength:
  • Ivermectin
    1.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Ear gel
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02QA03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • 10 gram gel in a tube consisting of aluminium with an external coating of white polyurethane and an internal coating of epoxy resin and a screw cap of polyethylene.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • Le Vet. B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2267
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0112/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Iceland
  • Ireland
  • Italy
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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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.
Polish (PDF)
Published on: 4/02/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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