| Code | 1786F | ||||||||||
| MA number | 58/0375/25-S | ||||||||||
| Product Form: | tbl flm 30x1x10 mg (blis.PVC/PVDC/Al-jednotk.bal.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | TEVA GmbH, Germany | ||||||||||
| Therapeutic Class: | 58 - HYPOTENSIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 06.11.2025 |
| Validity: | 06.11.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Macitentan Teva_11_2025.pdf
|
| SPC: |
SPC_Macitentan Teva_11_2025.pdf
|
| Safety feature | Yes |
| Data update: | 07.11.2025 |
