| Code | 5725D | ||||||||||
| MA number | 58/0232/20-S | ||||||||||
| Product Form: | tbl flm 30x1x5 mg (blis.PVC/PE/PVDC/Al-jednotliv.dáv.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | AOP Orphan Pharmaceuticals GmbH, Austria | ||||||||||
| Therapeutic Class: | 58 - HYPOTENSIVA | ||||||||||
| ATC: |
|
||||||||||
| 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 |
| SPC: |
SPC_Ambrisentan AOP_tbl flm_05_2024.pdf
|
| PIL: |
PIL_Ambrisentan AOP_tbl flm_05_2024.pdf
|
| Safety feature | Yes |
| Data update: | 18.03.2025 |
