| 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: |
|
||||||||||
| 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 |
