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PRODUCT DETAIL

Apremilast Krka 10 mg filmom obalené tablety Apremilast Krka 20 mg filmom obalené tablety Apremilast Krka 30 mg filmom obalené tablety

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:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AA Selective immunosuppressants
L04AA32 Apremilast
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
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