Namaxir 10 mg otopina za injekciju u napunjenoj štrcaljki
| Name | Namaxir 10 mg otopina za injekciju u napunjenoj štrcaljki |
|---|---|
| Marketing Authorisation Number | HR-H-138716970 |
| Active Substance | metotreksat |
| Composition | jedna napunjena štrcaljka od 0,40 ml sadrži 10 mg metotreksata |
| Pharmaceutical Form | otopina za injekciju u napunjenoj štrcaljki |
| Manufacturer | Actavis Italy S.p.A., Nerviano (Milano), Italija S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska |
| 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-530-09/19-02/211 |
| Registration Number | 381-12-01/38-23-13 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L04AX03 |
| Medicinal product marketed in the Croatia | Da |
| 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 |
