Code | 4159E | ||||||||||
MA number | 44/0166/23-S | ||||||||||
Product Form: | cps dur 100x500 mg (blis.PVC/Aclar/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | MAKPHARM d.o.o., Croatia | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 31.07.2023 |
Validity: | 31.07.2028 |
MA renewed: | Renewal application submitted |
SPC: | SPC_XYBAID 500 mg tvrdé kapsuly_09.2024.pdf |
PIL: | PIL_XYBAID 500 mg tvrdé kapsuly_09.2024.pdf |
Safety feature | Yes |
Data update: | 13.06.2024 |