| Code | 66359 | ||||||||||
| MA number | 15/0144/19-S | ||||||||||
| Product Form: | tbl flm 12x1000 KU (blis.Al/PVC/PVDC) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| MAH, country: | Sandoz GmbH, Austria | ||||||||||
| Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 28.12.1995 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Ospen_tbl flm_11.2024.pdf
|
| SPC: |
SPC_Ospen_tbl flm_11.2024.pdf
|
| Safety feature | Yes |
| Data update: | 16.05.2019 |
