Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Veterinary medicine
|
Name of medicinal product:
|
Ototop
|
Active substances:
|
|
ATC code:
|
QS02CA81
|
Dosage form:
|
ear drops, suspension
|
Strength:
|
5mg+23mg+5500RÜ 1ml
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
(last updated March 21, 2022)
|
Package information leaflet (PIL):
|
EST (last updated May 5, 2020)
|
Labelling:
|
(last updated March 21, 2022)
|
Indication:
|
For the treatment of infection of external auditory canal (otitis externa) in dogs and cats as well as primary and secondary infections of the skin and skin adnexa (hair, nails, sweat glands) in dogs, cats and guinea pigs, caused by the following miconazole and polymyxin B susceptible pathogens:
Fungi (including yeasts)
- Malassezia pachydermatis
- Candida spp.
- Microsporum spp.
- Trichophyton spp.
Gram-positive bacteria
- Staphylococcus spp.
- Streptococcus spp.
Gram-negative bacteria
- Pseudomonas spp.
- Escherichia coli
For the adjunct treatment of an infestation with Otodectes cynotis (ear mites) associated with Otitis externa.
|
Safety features:
|
No
|
Marketing authorization holder:
|
Livisto Int'l S.L.
|
Marketing authorization number:
|
2236
|
Marketing authorization issued on:
|
May 5, 2020
|
Marketing authorization expires on:
|
May 5, 2025
|
Marketing authorization procedure type:
|
Decentralised
|
Assessment report:
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1786754
|
Ototop
|
ear drops, suspension
|
5mg +23mg +5500RÜ 1ml 15ml 1TK
|
Prescription
|
|
|
|
|
|
1786765
|
Ototop
|
ear drops, suspension
|
5mg +23mg +5500RÜ 1ml 30ml 1TK
|
Prescription
|
|
|
|
|
|
1786776
|
Ototop
|
ear drops, suspension
|
5mg +23mg +5500RÜ 1ml 100ml 1TK
|
Prescription
|
|
|
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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