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PRODUCT DETAIL

Rumixafen 500 mikrogramov

Code 2360D
MA number 14/0270/19-S
Product Form: tbl flm 84x500 µg (blis.PVC/PVDC/Al)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Decentralised
Therapeutic Class: 14 - BRONCHODILATANTIA, ANTIASTHMATICA
ATC:
R RESPIRATORY SYSTEM
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03D OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03DX Other systemic drugs for obstructive airway diseases
R03DX07 Roflumilast
Shelf life: 36
Container: blister PVC/PVDC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 10.09.2019
SPC: SPC_Rumixafen_11.2020.doc  
PIL: PIL_Rumixafen_03/2023.pdf  
Safety feature Yes
Data update: 03.01.2024
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