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PRODUCT DETAIL

Miflonide Breezhaler 400

Code 2641C
MA number 56/0369/01-S
Product Form: plv icd 20(2x10)x400 µg (blis.PVC/PVDC/Al+1 inhalátor Breezhaler)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
Therapeutic Class: 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU)
ATC:
R RESPIRATORY SYSTEM
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03B OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03BA Glucocorticoids
R03BA02 Budesonide
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
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