| Code | 9036E | ||||||||||
| MA number | 59/0059/25-S | ||||||||||
| Product Form: | tbl flm 27 (4 x 10 mg + 4 x 20 mg + 19 x 30 mg) (blis.PVC/Al - bal.na zač.liečby) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
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| Shelf life: | 60 | ||||||||||
| Container: | blister 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: | 24.02.2025 |
| Validity: | 24.02.2030 |
| PIL: |
PIL_Apremilast STADA_02.2025.pdf
|
| SPC: |
SPC_Apremilast STADA_02.2025.pdf
|
| Safety feature | Yes |
| Data update: | 26.02.2025 |
