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PRODUCT DETAIL

Pulmicort 0,5 mg/ml

Code 13033
MA number 14/0318/00-S
Product Form: sus neb 20x2 ml (amp.PE)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
Therapeutic Class: 14 - BRONCHODILATANTIA, ANTIASTHMATICA
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: ampoule PE
Route of admin.: Inhalation use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 31.10.2000
Pediatric posology: Yes
Pediatric warnings: Yes
PIL: PIL Pulmicort 5 mg/ml_06/2023.pdf  
SPC: SPC_Pulmicort 0,5 mg_ml_01/2024.pdf  
Safety feature Yes
Data update: 05.02.2024
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