| Code | 0383C | ||||||||||
| MA number | 14/0338/16-S | ||||||||||
| Product Form: | plv icd 15x10 µg (fľ.HDPE+1 inhalátor) | ||||||||||
| 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 |
