Code | 5725D | ||||||||||
MA number | 58/0232/20-S | ||||||||||
Product Form: | tbl flm 30x1x5 mg (blis.PVC/PE/PVDC/Al-jednotliv.dáv.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | AOP Orphan Pharmaceuticals GmbH, Austria | ||||||||||
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 |
SPC: | SPC_Ambrisentan AOP_tbl flm_05_2024.pdf |
PIL: | PIL_Ambrisentan AOP_tbl flm_05_2024.pdf |
Safety feature | Yes |
Data update: | 03.02.2023 |