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PRODUCT DETAIL

Amidil Combi AmiHaler

Code 2193F
MA number 14/0437/25-S
Product Form: plv icd 30x1x85 µg/43 µg (blis.OPA/Al/PVC - Al/PET + inhalátor)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: Zaklady Farmaceutyczne POLPHARMA S.A., Poland
Therapeutic Class: 14 - BRONCHODILATANTIA, ANTIASTHMATICA
ATC:
R RESPIRATORY SYSTEM
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03A ADRENERGICS, INHALANTS
R03AL Adrenergics in combinations with anticholinergics incl. triple combinations with corticosteroids
R03AL04 Indacaterol and glycopyrronium bromide
Shelf life: 24
Route of admin.: Inhalation use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(3) hybrid application
MA issued: 06.01.2026
Validity: 06.01.2031
SPC: SPC_Amidil Combi AmiHaler_plv icd_12/2025_REG.pdf  
PIL: PIL_Amidil Combi AmiHaler_plv icd_12/2025_REG.pdf  
Safety feature Yes
Data update: 27.01.2026
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