| Code | 1722F | ||||||||||
| MA number | 59/0362/25-S | ||||||||||
| Product Form: | tbl flm 56x30 mg (blis.PVC/Al-neperfor.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Sandoz Pharmaceuticals d.d., Slovenia | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 19.11.2025 |
| Validity: | 19.11.2030 |
| PIL: |
PIL_Apremilast Sandoz_10_2025.pdf
|
| SPC: |
SPC_Apremilast Sandoz_10_2025.pdf
|
| Safety feature | Yes |
| Data update: | 21.11.2025 |
