| Code | 3586E | ||||||||||
| MA number | 36/0117/23-S | ||||||||||
| Product Form: | tbl flm 10x60 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Teva B.V., Netherland | ||||||||||
| Therapeutic Class: | 36 - ANTITUSSICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 11.05.2023 |
| Validity: | 11.05.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Ditustat Neo filmom obalené tablety_05_2023.pdf
|
| PIL: |
PIL_Ditustat Neo filmom obalené tablety_05_2023.pdf
|
| Safety feature | No |
| Data update: | 12.05.2023 |
