| Name |
Nilmat 50 mg tvrde kapsule |
| Marketing Authorisation Number |
HR-H-516585980 |
| Active Substance |
nilotinibklorid hidrat |
| Composition |
jedna tvrda kapsula sadrži 50 mg nilotiniba u obliku nilotinibklorid hidrata |
| Pharmaceutical Form |
Kapsula, tvrda |
| Manufacturer |
PharOS MT Ltd, Birzebbugia, Malta |
| Marketing Authorisation Holder |
Galenika International Kft., Baross utca 165/3, Budaörs, Mađarska |
| Marketing Authorisation Date |
30.10.2024 |
| MA Period of Validity |
30.10.2029 |
| Classification Number |
UP/I-530-09/23-01/305 |
| Registration Number |
381-12-01/70-24-15 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
L01EA03 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
