Code | 3753D | ||||||||||
MA number | 14/0338/16-S | ||||||||||
Product Form: | plv icd 30x10 µg (fľ.HDPE+1 inhalátor-bal.samostat.vydávané spoločne) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
Therapeutic Class: | 14 - BRONCHODILATANTIA, ANTIASTHMATICA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Inhalation use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 14.07.2016 |
SPC: | SPC_Braltus 10 mg_03.2020.doc |
PIL: | PIL_Braltus 10 mcg_09/2023.pdf |
Safety feature | Yes |
Data update: | 16.09.2021 |