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BONADIX
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1876776
Name of medicinal product:
BONADIX
Active substances:
Fluocinolone acetonide+Ciprofloxacin
Estonian
,
English
,
Latin
ATC code:
S02CA86
Dosage form:
ear drops, solution in single-dose container
Route of administration:
auricular use
Strengh:
0,25mg+3mg 1ml
Amount in package:
0.25ml 15TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Cetraxal Plus is indicated in adults and in children aged 6 months and older for the following infections: - Acute otitis externa (AOE) - Acute otitis media in patients with tympanostomy tubes (AOMT) caused by ciprofloxacin susceptible microorganisms (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated February 7, 2023)
Package information leaflet (PIL):
EST
(last updated February 7, 2023)
Labelling:
(last updated February 7, 2023)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Orivas UAB
Marketing authorization number:
1097323
Marketing authorization issued on:
February 7, 2023
Marketing authorization expires on:
February 7, 2028
Marketing authorization procedure type:
Mutual recognition
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Perscription conditions and restrictions
Description
Additional condition
Ei ole lubatud väljastada korduvretsepti
Entry/Changing date: March 21, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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