| Code | 3221B | ||||||||||
| MA number | 58/0064/15-S | ||||||||||
| Product Form: | tbl flm 112x62,5 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Accord Healthcare Polska Sp. z o.o., Poland | ||||||||||
| Therapeutic Class: | 58 - HYPOTENSIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 02.03.2015 |
| Pediatric posology: | Yes |
| PIL: |
PIL_Bosentan Accord_02_2023.docx
|
| SPC: |
SPC_Bosentan Accord_02/2023.pdf
|
| Safety feature | Yes |
| Data update: | 31.08.2021 |
