| Code | 0347D | ||||||||||
| MA number | 42/0025/19-S | ||||||||||
| Product Form: | tbl flm 30x1x0,5 mg (blis.Al/OPA/Al/PVC-jednotliv.dáv.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Farmak International Sp. z o.o., Poland | ||||||||||
| Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 30.01.2019 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Entecavir FMK_tbl flm_05.2025.pdf
|
| SPC: |
SPC_Entecavir FMK_tbl flm_05.2025.pdf
|
| Safety feature | Yes |
| Data update: | 16.10.2023 |
