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PRODUCT DETAIL

Pulmozyme

Code 80404
MA number 52/0392/97-S
Product Form: sol neb 30x2,5 ml (amp.PE)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
Therapeutic Class: 52 - EXPECTORANTIA, MUCOLYTICA
ATC:
R RESPIRATORY SYSTEM
R05 COUGH AND COLD PREPARATIONS
R05C EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
R05CB Mucolytics
R05CB13 Dornase alfa (desoxyribonuclease)
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: 30.09.1997
Pediatric indication: Yes
Pediatric posology: Yes
SPC: SPC_Pulmozyme_06.2018.doc  
PIL: PIL_Pulmozyme_06.2018.doc  
Safety feature Yes
Data update: 08.06.2018
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