Code | 8895B | ||||||||||
MA number | 14/0126/16-S | ||||||||||
Product Form: | plv inh 1x60 dávok (inhalátor plast.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
Therapeutic Class: | 14 - BRONCHODILATANTIA, ANTIASTHMATICA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | plastic inhaler | ||||||||||
Route of admin.: | Inhalation use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 06.04.2016 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Bufomix Easyhaler 80_4,5_12.2019.doc |
SPC: | SPC_Bufomix Easyhaler 80_4,5_10.2020.doc |
Safety feature | Yes |
Data update: | 16.12.2019 |