Veterinary Medicines

Otimectin vet. 1 mg/g ear gel for cats

Authorised
  • Ivermectin
Download as PDF

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
Withdrawal period by route of administration:
  • Auricular use
    • Cat
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
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
Download

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
Download

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
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."