Code | 8458C | ||||||||||
MA number | 69/0232/18-S | ||||||||||
Product Form: | aer ors 1x30 ml/176 vstrekov (fľ.HDPE s dáv.pumpou) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Cassella-med GmbH & Co. KG, Germany | ||||||||||
Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 36 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Oromucosal use |
Prescription Status: | Medicinal product not subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 20.07.2018 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: | PIL_Orocalm 1,5 mg/ml _11/2023.pdf |
SPC: | SPC_Orocalm 1,5 mg/ml_11/2023.pdf |
Safety feature | No |
Data update: | 13.12.2023 |