Code | 0644E | ||||||||||
MA number | 87/0117/22-S | ||||||||||
Product Form: | pas ocp 1x20x4 mg (obal PP) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | OMEGA PHARMA a.s., Czechia | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 30 | ||||||||||
Route of admin.: | Oromucosal use |
Prescription Status: | Medicinal product not subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 24.05.2022 |
Validity: | 24.05.2027 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
Pediatric warnings: | Yes |
SPC: |
|
PIL: |
|
Safety feature | No |
Data update: | 02.03.2023 |