| Code | 4499D | ||||||||||
| MA number | 30/0112/20-S | ||||||||||
| Product Form: | tbl mod 60x150 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Neuraxpharm Bohemia s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 30 - ANTIDEPRESSIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 18.05.2020 |
| Validity: | 18.05.2025 |
| MA renewed: | Renewal application submitted |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Azoneurax_05.2023.pdf
|
| SPC: |
SPC_Azoneurax_05.2023.pdf
|
| Safety feature | Yes |
| Data update: | 10.05.2022 |
