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PRODUCT DETAIL

SINGULAIR 4 mg granulát

Code 64443
MA number 14/0039/09-S
Product Form: gra por 20x4 mg (vrecko PE/Al/PES)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Mutual recognition procedure
Therapeutic Class: 14 - BRONCHODILATANTIA, ANTIASTHMATICA
ATC:
R RESPIRATORY SYSTEM
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03D OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03DC Leukotriene receptor antagonists
R03DC03 Montelukast
Shelf life: 24
Container: sachet PE/Al/PES
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 27.01.2009
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
PIL: PIL_Singulair 4 mg_05/2023.pdf  
SPC: SPC_Singulair 4 mg_05/2023.pdf  
Safety feature Yes
Data update: 15.03.2018
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