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: |
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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 |