| Code | 8003E | ||||||||||
| MA number | 59/0292/24-S | ||||||||||
| Product Form: | tbl flm 27 (4x10 mg + 4x20 mg + 19x30 mg) - (blis.PVC/PCTFE/PVC/Al) - zač. liečba | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | TEVA Pharmaceuticals Slovakia s.r.o., Slovakia | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PCTFE/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 25.11.2024 |
| Validity: | 25.11.2029 |
| SPC: |
SPC_Apremilast Teva_05.2025.pdf
|
| PIL: |
PIL_Apremilast Teva_05.2025.pdf
|
| Safety feature | Yes |
| Data update: | 10.06.2025 |
