Sumamed 500 mg tablete za oralnu suspenziju
| Name | Sumamed 500 mg tablete za oralnu suspenziju |
|---|---|
| Marketing Authorisation Number | HR-H-120748759 |
| Active Substance | azitromicin dihidrat |
| Composition | svaka tableta za oralnu suspenziju sadrži 500 mg azitromicina u obliku azitromicin dihidrata |
| Pharmaceutical Form | tableta za oralnu suspenziju |
| Packaging [MA Number for Packaging] | 1 tableta u blisteru, u kutiji [HR-H-120748759-01] 2 tablete u blisteru, u kutiji [HR-H-120748759-02] 3 tablete u blisteru, u kutiji [HR-H-120748759-03] 6 tableta u blisteru, u kutiji [HR-H-120748759-04] 12 tableta u blisteru, u kutiji [HR-H-120748759-05] 24 tablete u blisteru, u kutiji [HR-H-120748759-06] |
| Manufacturer | Pliva Hrvatska d.o.o., Zagreb, Hrvatska |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 30.01.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/22-02/72 |
| Registration Number | 381-12-01/70-23-03 |
| Prescription | na recept |
| Type of prescription | neponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | J01FA10 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
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. |
