Azibiot 500 mg filmom obložene tablete
| Name | Azibiot 500 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-890943761 |
| Active Substance | azitromicin dihidrat |
| Composition | jedna filmom obložena tableta sadrži 500 mg azitromicina u obliku azitromicindihidrata |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Krka d.d., Novo mesto, Novo Mesto, Slovenija Krka Polska Sp. z o.o., Varšava, Poljska |
| Marketing Authorisation Holder | Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska |
| Marketing Authorisation Date | 09.11.2020 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/18-02/279 |
| Registration Number | 381-12-01/38-20-07 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | neponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | J01FA10 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| SmPC | download |
| PL | download |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o povećanoj stopi recidiva hematoloških maligniteta i smrtnosti kod bolesnika podvrgnutih transplantaciji hematopoetskih matičnih stanica (HSCT) liječenih azitromicinom | 02.05.2018 | Belupo lijekovi i kozmetika, Jadran – Galenski Laboratorij d.d., Krka-Farma d.o.o., PharmaS d.o.o., Pliva Hrvatska d.o.o. i Sandoz d.o.o. |
