Code | 6797C | ||||||||||
MA number | 69/0018/18-S | ||||||||||
Product Form: | aer nao 1x10 ml (fľ.HDPE biela) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | McNeil Healthcare (Ireland) Limited, Ireland | ||||||||||
Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 36 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Nasal use |
Prescription Status: | Medicinal product not subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 22.01.2018 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
PIL: | PIL_OLYNTH PLUS 1mg/50 mg/ml_10/2023.pdf |
SPC: | SPC_OLYNTH PLUS 1 mg/50 mg/ml_10/2023.pdf |
Safety feature | No |
Data update: | 25.09.2023 |