| Code | 2191B | ||||||||||
| MA number | 42/0074/91-S | ||||||||||
| Product Form: | tbl 28x480 mg (blis.PVC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| MAH, country: | Adamed Pharma S.A., Poland | ||||||||||
| Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 60 | ||||||||||
| Container: | blister PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 11.10.1991 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_BISEPTOL 100 mg_20mg, 400 mg_80 mg tbl_10.2021.pdf
|
| SPC: |
SPC_BISEPTOL 100 mg_20mg, 400 mg_80 mg tbl_10.2021.pdf
|
| Safety feature | Yes |
| Data update: | 27.09.2021 |
