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PRODUCT DETAIL

Hydroxykarbamid medac 500 mg tvrdé kapsuly

Code 8089E
MA number 44/0306/24-S
Product Form: cps dur 100x500 mg (blis.Al/PVC/PVDC)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
MAH, country: medac Gesellschaft für klinische Spezialpräparate m.b.H., Germany
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: 48
Container: blister Al/PVC/PVDC
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10a well-established use application
MA issued: 22.11.2024
Validity: 22.11.2029
SPC: SPC_Hydroxykarbamid medac 500 mg tvrdé kapsuly_12.2024.pdf  
PIL: PIL_Hydroxykarbamid medac 500 mg tvrdé kapsuly_12.2024.pdf  
Safety feature Yes
Data update: 02.12.2024
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