Veterinary Medicines

OTOSTATIC

Authorised
  • Nystatin
  • NEOMYCIN SULFATE
  • Bacitracin
  • Hydrocortisone acetate
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Product identification

Medicine name:
OTOSTATIC
Active substance:
  • Nystatin
  • NEOMYCIN SULFATE
  • Bacitracin
  • Hydrocortisone acetate
Target species:
  • Dog
  • Cat
Route of administration:
  • Auricular use

Product details

Active substance and strength:
  • Nystatin
    10.00
    milligram(s)
    /
    1.00
    gram(s)
  • NEOMYCIN SULFATE
    4.00
    milligram(s)
    /
    1.00
    gram(s)
  • Bacitracin
    16.00
    milligram(s)
    /
    1.00
    gram(s)
  • Hydrocortisone acetate
    10.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Ear drops, suspension
Withdrawal period by route of administration:
  • Auricular use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02CA03
Legal status of supply:
This information is not available for this product.
Authorisation status:
  • Valid
Authorised in:
  • Romania
Available in:
  • Romania
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Complete application (stand-alone) - Directive No 2001/82/EC
Marketing authorisation holder:
  • Pasteur Filiala Filipesti S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Pasteur Filiala Filipesti S.A.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 150151
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: 4/05/2022
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