Code | 7287E | ||||||||||
MA number | 59/0207/24-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_08.2024.pdf |
SPC: | SPC_Apremilast_Krka _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 |