Code | 7843E | ||||||||||
MA number | 59/0239/24-S | ||||||||||
Product Form: | cps dur 21x3 mg (blis.OPA/Al/PVC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Sandoz Pharmaceuticals d.d., Slovenia | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
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: | 04.11.2024 |
Validity: | 04.11.2029 |
PIL: | PIL_Pomalidomide Sandoz_10_2024.pdf |
SPC: | SPC_Pomalidomide Sandoz_10_2024.pdf |
Dokument: | Pomalidomid_Prirucka pre zdravotnickych pracovnikov.pdf |
Dokument: | Pomalidomid_Prirucka pre pacientov.pdf |
Dokument: | Pomalidomid_Formulár informovanosti o rizikách.pdf |
Safety feature | Yes |
Data update: | 05.11.2024 |