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PRODUCT DETAIL

Septolete extra 1,5 mg/ml + 5 mg/ml

Code 5043B
MA number 69/0294/15-S
Product Form: aer ors 1x30 ml/250 vstrekov (fľ.HDPEs rozpraš.)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Decentralised
Therapeutic Class: 69 - OTORHINOLARYNGOLOGICA
ATC:
R RESPIRATORY SYSTEM
R02 THROAT PREPARATIONS
R02A THROAT PREPARATIONS
R02AX Other throut preparations
R02AX03 Benzydamine
Shelf life: 36
Container: bottle HDPE with nebuliser
Route of admin.: Oromucosal use
Prescription Status: Medicinal product not subject to medical prescription.
Legal basis: Article 10(3) hybrid application
MA issued: 17.07.2015
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric contraindication: Yes
SPC: SPC_Septolete extra 1,5mg_03.2021.pdf  
PIL: PIL_Septolete extra 1,5mg_03.2021.pdf  
Safety feature No
Data update: 06.08.2021
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