| Code | 7277E | ||||||||||
| MA number | 59/0205/24-S | ||||||||||
| Product Form: | tbl flm 27 (4x10 mg + 4x20 mg + 19x30 mg - začiat.liečba) (blis.OPA/Al/PVC//Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | blister OPA/Al/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: | 28.08.2024 |
| Validity: | 28.08.2029 |
| PIL: |
PIL_Apremilast Krka d.d._08.2024.pdf
|
| SPC: |
SPC_Apremilast Krka d.d._08.2024.pdf
|
| Dokument: |
VHS_SK_H_0306_0307_0309_001-002_DC_Apremilast Krka d.d.Apremilast Krka Apremilast HCS_PAR.pdf
|
| Dokument: |
VHS_súhrn_SK_H_0306_0307_0309_001-002_DC_Apremilast Krka d.d.,Apremilast Krka, Apremilast HCS_Summary PAR.pdf
|
| Safety feature | Yes |
| Data update: | 09.09.2024 |
