Veterinary Medicines

OTOSPECTRINE

Authorised
  • Dexamethasone
  • Sulfiram
  • Lidocaine hydrochloride
  • POLYMYXIN B SULFATE
  • NEOMYCIN SULFATE
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Product identification

Medicine name:
OTOSPECTRINE
Active substance:
  • Dexamethasone
  • Sulfiram
  • Lidocaine hydrochloride
  • POLYMYXIN B SULFATE
  • NEOMYCIN SULFATE
Target species:
  • Dog
  • Cat
Route of administration:
  • Ocular use

Product details

Active substance and strength:
  • Dexamethasone
    1.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Sulfiram
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Lidocaine hydrochloride
    40.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • POLYMYXIN B SULFATE
    10000.00
    international unit(s)
    /
    1.00
    millilitre(s)
  • NEOMYCIN SULFATE
    5000.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Ear drops, suspension
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02AA07
  • QS02AA11
  • QS02BA06
  • QS02QA02
Legal status of supply:
This information is not available for this product.
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • KELA Kempisch Laboratorium Kela Laboratoria
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 210198
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Romanian (PDF)
Published on: 21/12/2021
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