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PRODUCT DETAIL

Infalin duo 3 mg/ml + 0,25 mg/ml ušná roztoková instilácia

Code 2323A
MA number 69/0387/12-S
Product Form: int ots 1x10 ml (fľ.PE s kvapkadlom)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Mutual recognition procedure
Therapeutic Class: 69 - OTORHINOLARYNGOLOGICA
ATC:
S SENSORY ORGANS
S02 OTOLOGICALS
S02C CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION
S02CA Corticosteroids and antiinfectives in combination
S02CA05 Fluocinolone acetonide and antiinfectives
Shelf life: 24
Container: dropper bottle PE
Route of admin.: Auricular use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - known active substance
MA issued: 21.08.2012
Pediatric indication: Yes
Pediatric posology: Yes
SPC: SPC_Infalin duo_01.2020.doc  
PIL: PIL_Infalin duo_09.2020.docx  
Safety feature Yes
Data update: 15.04.2019
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