| Code | 0890F | ||||||||||
| MA number | 65/0285/25-S | ||||||||||
| Product Form: | tbl flm 50x1x75 mg/25 mg (blis.OPA/Al/PVC/Al) - jednotk.bal. | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
| Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 12 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 28.08.2025 |
| Validity: | 28.08.2030 |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Delanxara 75 mg_25 mg filmom obalené tablety_08_2025.pdf
|
| SPC: |
SPC_Delanxara 75 mg_25 mg filmom obalené tablety_08_2025.pdf
|
| Safety feature | Yes |
| Data update: | 28.08.2025 |
