| Code | 2189F | ||||||||||
| MA number | 58/0445/25-S | ||||||||||
| Product Form: | tbl flm 15x10 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
| Therapeutic Class: | 58 - HYPOTENSIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 48 | ||||||||||
| Container: | blister PVC/PE/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 01.01.2026 |
| Validity: | 01.01.2031 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Macitentan STADA 10 mg filmom obalené teblety_12_2025.pdf
|
| SPC: |
SPC_Macitentan STADA 10 mg filmom obalené tablety_12_2025.pdf
|
| Safety feature | Yes |
| Data update: | 05.01.2026 |
