Code | 2855C | ||||||||||
MA number | 56/0369/01-S | ||||||||||
Product Form: | plv icd 120(2 bal.po 6x10)x400 µg (blis.PVC/PVDC/Al+2 inhalátory Breezhaler-multibal.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | National | ||||||||||
MAH, country: | Novartis Slovakia s.r.o., Slovakia | ||||||||||
Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PVC/PVDC/Al | ||||||||||
Route of admin.: | Inhalation use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 08.11.2001 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Miflonide Breezhaler_08.2018.doc |
PIL: | PIL_Miflonide Breezhaler_07_2021.pdf |
Safety feature | Yes |
Data update: | 30.05.2018 |