Nilotinib STADA 50 mg tvrde kapsule
| Name | Nilotinib STADA 50 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-000953694 |
| Active Substance | nilotinibklorid dihidrat |
| Composition | jedna tvrda kapsula sadrži 50 mg nilotiniba (u obliku nilotinibklorid dihidrata) |
| Pharmaceutical Form | Kapsula, tvrda |
| Manufacturer | STADA Arzneimittel AG, Bad Vilbel, Njemačka
Clonmel Healthcare Ltd., Clonmel, Co. Tipperary, Irska STADA Arzneimittel GmbH, Beč, Austrija Pharos Pharmaceutical Oriented Services Ltd., Metamorfossi Attikis, Grčka |
| Marketing Authorisation Holder | Stada d.o.o., Hercegovačka 14, Zagreb, Hrvatska |
| Marketing Authorisation Date | 27.06.2024 |
| MA Period of Validity | 27.06.2029 |
| Classification Number | UP/I-530-09/23-01/92 |
| Registration Number | 381-12-01/70-24-08 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L01EA03 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
