Namaxir 15 mg otopina za injekciju u napunjenoj štrcaljki
| Name | Namaxir 15 mg otopina za injekciju u napunjenoj štrcaljki |
|---|---|
| Marketing Authorisation Number | HR-H-214162779 |
| Active Substance | metotreksat |
| Composition | jedna napunjena štrcaljka od 0,38 ml sadrži 15 mg metotreksata |
| Pharmaceutical Form | otopina za injekciju u napunjenoj štrcaljki |
| Manufacturer | S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska Biomedica Foscama Industria Chimico-farmaceutica S.p.A., Ferentino, Italija |
| Marketing Authorisation Holder | Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date | 24.02.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/19-02/213 |
| Registration Number | 381-12-01/38-23-13 |
| 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 | L04AX03 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o preporukama za sprječavanje potencijalno fatalnih pogrešaka u doziranju metotreksata za liječenje upalnih bolesti | 02.12.2019 | Sandoz d.o.o., Pliva Hrvatska d.o.o., Actavis Group PTC ehf, Cipla Europe NV |
