| Code | 5726D | ||||||||||
| MA number | 58/0233/20-S | ||||||||||
| Product Form: | tbl flm 30x1x10 mg (blis.PVC/PVDC/Al-jednotliv.dáv) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 58 - HYPOTENSIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 60 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 27.10.2020 |
| Validity: | 27.10.2025 |
| PIL: |
PIL_Ambrisentan AOP_09/2021.pdf
|
| SPC: |
SPC_Ambrisentan AOP_02/2023.pdf
|
| Safety feature | Yes |
| Data update: | 03.02.2023 |
