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PRODUCT DETAIL

XYBAID 500 mg tvrdé kapsuly

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:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01X OTHER ANTINEOPLASTIC AGENTS
L01XX Other antineoplastic agents
L01XX05 Hydroxycarbamide
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
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