Code | 7212E | ||||||||||
MA number | 18/0210/24-S | ||||||||||
Product Form: | tbl flm 30x100 mg (blis.PVC/PE/PVDC//Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Zentiva, k.s., Czechia | ||||||||||
Therapeutic Class: | 18 - ANTIDIABETICA (VRÁTANE INZULÍNU) | ||||||||||
ATC: |
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Shelf life: | 18 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 26.08.2024 |
Validity: | 26.08.2029 |
PIL: | PIL_Jazeta Novum 50 mg, 100 mg_tbl flm_08.2024.pdf |
SPC: | SPC_Jazeta Novum 50 mg, 100 mg_tbl flm_08.2024.pdf |
Safety feature | Yes |
Data update: | 09.09.2024 |