Veterinary Medicines

Ototop Ear Drops and Cutaneous Suspension for Dogs, Cats and Guinea Pigs

Authorised
  • POLYMYXIN B SULFATE
  • Prednisolone acetate
  • Miconazole nitrate
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Product identification

Medicine name:
Ototop Ear Drops and Cutaneous Suspension for Dogs, Cats and Guinea Pigs
OTOTOP, picături auriculare și suspensie cutanată pentru câini, pisici și porcușori de Guineea
Active substance:
  • POLYMYXIN B SULFATE
  • Prednisolone acetate
  • Miconazole nitrate
Target species:
  • Dog
  • Cat
  • Guinea pig
Route of administration:
  • Cutaneous use
  • Auricular use

Product details

Active substance and strength:
  • POLYMYXIN B SULFATE
    0.53
    milligram(s)
    /
    1.00
    millilitre(s)
  • Prednisolone acetate
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Miconazole nitrate
    23.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Cutaneous/ear drops suspension
Withdrawal period by route of administration:
  • Cutaneous use
    • Dog
    • Cat
    • Guinea pig
  • Auricular use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02CA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Available in:
  • Romania
Package description:
  • (ID3) 100 millilitre(s): Box (Cardboard) with 1 Bottle (Low Density PolyEthylene) with 100 millilitre(s), closed with Screw cap (PolyPropylene)
  • (ID2) 30 millilitre(s): Box (Cardboard) with 1 Bottle (Low Density PolyEthylene) with 30 millilitre(s), closed with Screw cap (PolyPropylene)
  • (ID1) 15 millilitre(s): Box (Cardboard) with 1 Bottle (Low Density PolyEthylene) with 15 millilitre(s), closed with Screw cap (PolyPropylene)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Industrial Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Industrial Veterinaria S.A.
  • aniMedica Herstellungs GmbH
  • aniMedica GmbH
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 200073
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0321/001
Concerned member states:
  • Austria
  • Belgium
  • Cyprus
  • Czechia
  • Estonia
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Malta
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain

Documents

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Romanian (PDF)
Published on: 12/11/2024
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